<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01688310</url>
  </required_header>
  <id_info>
    <org_study_id>PRO11080657</org_study_id>
    <nct_id>NCT01688310</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision</brief_title>
  <official_title>A Randomized Controlled Trial of Open Surgical vs. Minimally-invasive Voluntary Adult Male Circumcision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Católica de Moçambique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Catholic University of Mozambique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Católica de Moçambique</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposed randomized controlled trial will provide important data which will inform and&#xD;
      enable the Mozambican government and global health programs to more effectively scale-up&#xD;
      circumcision services. The investigators postulate that voluntary medical male circumcision&#xD;
      using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method:&#xD;
      it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and&#xD;
      is more cost effective than any other currently available technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Voluntary medical male circumcision (VMMC) is a priority preventive intervention and&#xD;
      Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV&#xD;
      infection would be prevented between now and 2025 for every seven circumcisions performed in&#xD;
      Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13%&#xD;
      among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where&#xD;
      the study will take place, are currently circumcised.&#xD;
&#xD;
      In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC&#xD;
      techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows&#xD;
      in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male&#xD;
      Circumcision (WHO, 2011): &quot;WHO and other health authorities wish to identify one or more&#xD;
      devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid&#xD;
      healing than current methods and/or might entail less risk of HIV transmission in the&#xD;
      post-operative period; (c) could be performed safely by health-care providers with a minimal&#xD;
      level of training; and (d) would be cost-effective compared to standard surgical methods for&#xD;
      male circumcision scale up.&quot;&#xD;
&#xD;
      This proposed randomized controlled trial will provide important data which will inform and&#xD;
      enable the Mozambican government and PEPFAR to more effectively scale-up circumcision&#xD;
      services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue&#xD;
      adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer&#xD;
      for both surgeons and patients, heals sooner, and is more cost effective than any other&#xD;
      currently available technique.&#xD;
&#xD;
      The investigators propose a randomized controlled trial (RCT) comparing this&#xD;
      minimally-invasive circumcision technique to the open surgical technique:&#xD;
&#xD;
        -  Gomco clamp with tissue adhesive: 100 men&#xD;
&#xD;
        -  Open surgical circumcision: 100 men&#xD;
&#xD;
      The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on&#xD;
      its use in Africa. Tissue adhesive is widely used in multiple areas of medicine;&#xD;
      specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue&#xD;
      adhesives to be superior to suture closure in circumcision in boys. The investigators refer&#xD;
      to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these&#xD;
      two independently-validated components have only been coupled in observational studies among&#xD;
      men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT&#xD;
      among adult men. The open surgical method is PEPFAR-approved and will serve as the control&#xD;
      intervention.&#xD;
&#xD;
      Population: Men &gt; 18 years of age who desire male circumcision Sample size: 200 (100 men in&#xD;
      each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision&#xD;
      plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14 days&#xD;
      and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative Duration</measure>
    <time_frame>1 year</time_frame>
    <description>Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difficulty in Learning and Performing Technique</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated by doctor survey, 5 point Likert scale:&#xD;
Gomco technique is much easier&#xD;
Gomco technique is easier&#xD;
Neutral&#xD;
Open surgical technique is easier&#xD;
Open surgical technique is much easier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Required for Healing</measure>
    <time_frame>Within 6 weeks after surgery</time_frame>
    <description>Time required for healing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct Costs</measure>
    <time_frame>Within 6 weeks after surgery</time_frame>
    <description>the cost of labor, supplies and equipment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Experienced</measure>
    <time_frame>2 days after surgery</time_frame>
    <description>Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Patient Satisfaction</measure>
    <time_frame>Within 6 weeks after surgery</time_frame>
    <description>Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic Result</measure>
    <time_frame>Within 6 weeks after surgery</time_frame>
    <description>Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 yr</time_frame>
    <description>Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Surgical Technique</condition>
  <arm_group>
    <arm_group_label>Open surgical circumcision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gomco clamp with tissue adhesive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gomco Clamp with Tissue Adhesive</intervention_name>
    <description>According to WHO (2011), the Gomco clamp has &quot;…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision.&quot; Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC.</description>
    <arm_group_label>Gomco clamp with tissue adhesive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open surgical circumcision</intervention_name>
    <description>The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.</description>
    <arm_group_label>Open surgical circumcision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men &gt; 18 years of age requesting circumcision&#xD;
&#xD;
          -  No penile anatomical abnormalities or infections&#xD;
&#xD;
          -  Able to provide informed consent to participate&#xD;
&#xD;
          -  Willing to participate in follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current illness&#xD;
&#xD;
          -  Penile abnormality or infection which contraindicates or would complicate circumcision&#xD;
&#xD;
          -  History of bleeding disorder&#xD;
&#xD;
          -  Past reaction to local anesthetic&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Millard, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Catholic de Mozambique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Saúde São Lucas, UCM</name>
      <address>
        <city>Beira</city>
        <state>Sofala</state>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
  </location_countries>
  <reference>
    <citation>Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.</citation>
    <PMID>17321311</PMID>
  </reference>
  <reference>
    <citation>Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.</citation>
    <PMID>11798403</PMID>
  </reference>
  <reference>
    <citation>Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.</citation>
    <PMID>12478073</PMID>
  </reference>
  <reference>
    <citation>Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.</citation>
    <PMID>15832878</PMID>
  </reference>
  <reference>
    <citation>Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.</citation>
    <PMID>15763713</PMID>
  </reference>
  <reference>
    <citation>Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.</citation>
    <PMID>15788922</PMID>
  </reference>
  <reference>
    <citation>Bailey RC, Egesah O, Rosenberg S. Male circumcision for HIV prevention: a prospective study of complications in clinical and traditional settings in Bungoma, Kenya. Bull World Health Organ. 2008 Sep;86(9):669-77. doi: 10.2471/blt.08.051482.</citation>
    <PMID>18797642</PMID>
  </reference>
  <reference>
    <citation>Kim HH, Goldstein M. High complication rates challenge the implementation of male circumcision for HIV prevention in Africa. Nat Clin Pract Urol. 2009 Feb;6(2):64-5. doi: 10.1038/ncpuro1279. Epub 2008 Dec 23.</citation>
    <PMID>19107114</PMID>
  </reference>
  <reference>
    <citation>Lane V, Vajda P, Subramaniam R. Paediatric sutureless circumcision: a systematic literature review. Pediatr Surg Int. 2010 Feb;26(2):141-4. doi: 10.1007/s00383-009-2475-y. Epub 2009 Aug 26.</citation>
    <PMID>19707772</PMID>
  </reference>
  <reference>
    <citation>Elmore JM, Smith EA, Kirsch AJ. Sutureless circumcision using 2-octyl cyanoacrylate (Dermabond): appraisal after 18-month experience. Urology. 2007 Oct;70(4):803-6. doi: 10.1016/j.urology.2007.07.002.</citation>
    <PMID>17991565</PMID>
  </reference>
  <reference>
    <citation>Kaye JD, Kalisvaart JF, Cuda SP, Elmore JM, Cerwinka WH, Kirsch AJ. Sutureless and scalpel-free circumcision--more rapid, less expensive and better? J Urol. 2010 Oct;184(4 Suppl):1758-62. doi: 10.1016/j.juro.2010.03.081. Epub 2010 Aug 21.</citation>
    <PMID>20728122</PMID>
  </reference>
  <reference>
    <citation>World Health Organization. Male circumcision: Global trends and determinants of prevalence, safety and acceptability, 2007</citation>
  </reference>
  <reference>
    <citation>World Health Organization. Manual for Male Circumcision under Local Anaesthesia. 2009.</citation>
  </reference>
  <reference>
    <citation>World Health Organization. Manual for early infant male circumcision under local anaesthesia. 2010.</citation>
  </reference>
  <reference>
    <citation>World Health Organization. Framework for Clinical Evaluation of Devices for Adult Male Circumcision. 2011.</citation>
  </reference>
  <reference>
    <citation>PEPFAR Next Generation Indicators Reference Guide, Vers 1.1, 2009 At www.pepfar.gov/documents/organization/81097.pdf</citation>
  </reference>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>June 7, 2013</results_first_submitted>
  <results_first_submitted_qc>June 30, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 10, 2013</results_first_posted>
  <last_update_submitted>June 30, 2013</last_update_submitted>
  <last_update_submitted_qc>June 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Católica de Moçambique</investigator_affiliation>
    <investigator_full_name>Dr. Peter Millard</investigator_full_name>
    <investigator_title>Clinical Director of the Health Center</investigator_title>
  </responsible_party>
  <keyword>Gomco clamp instrument</keyword>
  <keyword>Tissue adhesive</keyword>
  <keyword>Open surgical circumcision</keyword>
  <keyword>Minimally-invasive circumcision</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment between October 30, 2012 and February 2, 2013. University teaching clinic.</recruitment_details>
      <pre_assignment_details>241 interviewed, Excluded (n=41)&#xD;
Inclusion criteria not met (n=19)&#xD;
Under 18 years of age (n=17)&#xD;
Phimosis (n=2)&#xD;
Declined to participate (n=22) 200 were randomized and underwent circumcision in the arm allocated</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Open Surgical Circumcision</title>
          <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
        </group>
        <group group_id="P2">
          <title>Gomco Clamp With Tissue Adhesive</title>
          <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Open Surgical Circumcision</title>
          <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
        </group>
        <group group_id="B2">
          <title>Gomco Clamp With Tissue Adhesive</title>
          <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.8" spread="4.9"/>
                    <measurement group_id="B2" value="22.3" spread="4.7"/>
                    <measurement group_id="B3" value="22.5" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18-20 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>21-24 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=25 yrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Mozambique</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intraoperative Duration</title>
        <description>Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.</description>
        <time_frame>1 year</time_frame>
        <population>All participants</population>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Duration</title>
          <description>Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.</description>
          <population>All participants</population>
          <units>Min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="6.6"/>
                    <measurement group_id="O2" value="12.8" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difficulty in Learning and Performing Technique</title>
        <description>Evaluated by doctor survey, 5 point Likert scale:&#xD;
Gomco technique is much easier&#xD;
Gomco technique is easier&#xD;
Neutral&#xD;
Open surgical technique is easier&#xD;
Open surgical technique is much easier</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Senior Physicians</title>
            <description>Physicians who had extensive prior experience performing open surgical circumcisions.</description>
          </group>
          <group group_id="O2">
            <title>Junior Physicians</title>
            <description>Physicians who had very limited prior experience performing open surgical circumcisions.</description>
          </group>
        </group_list>
        <measure>
          <title>Difficulty in Learning and Performing Technique</title>
          <description>Evaluated by doctor survey, 5 point Likert scale:&#xD;
Gomco technique is much easier&#xD;
Gomco technique is easier&#xD;
Neutral&#xD;
Open surgical technique is easier&#xD;
Open surgical technique is much easier</description>
          <units>units on Likert scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Required for Healing</title>
        <description>Time required for healing</description>
        <time_frame>Within 6 weeks after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Required for Healing</title>
          <description>Time required for healing</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
                <count group_id="O2" value="96"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Healed at 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Healed at 4 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8"/>
                    <measurement group_id="O2" value="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Healed at 6 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Direct Costs</title>
        <description>the cost of labor, supplies and equipment</description>
        <time_frame>Within 6 weeks after surgery</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Experienced</title>
        <description>Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)</description>
        <time_frame>2 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Experienced</title>
          <description>Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)</description>
          <units>units on 10 point pain scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.9"/>
                    <measurement group_id="O2" value="1.8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Patient Satisfaction</title>
        <description>Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.</description>
        <time_frame>Within 6 weeks after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Patient Satisfaction</title>
          <description>Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="95"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not satisfied</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cosmetic Result</title>
        <description>Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).</description>
        <time_frame>Within 6 weeks after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmetic Result</title>
          <description>Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Regular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irregular</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Scalloped</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Events</title>
        <description>Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection</description>
        <time_frame>1 yr</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Open Surgical Circumcision</title>
            <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
          </group>
          <group group_id="O2">
            <title>Gomco Clamp With Tissue Adhesive</title>
            <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate bleeding (suturing required)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Infection (antibiotic required)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Open Surgical Circumcision</title>
          <description>Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.</description>
        </group>
        <group group_id="E2">
          <title>Gomco Clamp With Tissue Adhesive</title>
          <description>Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Serious post-operative complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Mild post-operative bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Moderate post-operative bleeding</sub_title>
                <description>Required suturing to stop bleeding</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Post-operative infection</sub_title>
                <description>Required antibiotic</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Peter Millard</name_or_title>
      <organization>Catholic University of Mozambique Medical School</organization>
      <phone>2078663503</phone>
      <email>pmillard@mac.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01688310
org study id: PRO11080657
nct id: NCT01688310
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This proposed randomized controlled trial will provide important data which will inform and
      enable the Mozambican government and global health programs to more effectively scale-up
      circumcision services. The investigators postulate that voluntary medical male circumcision
      using the Gomco clamp coupled with tissue adhesive meets WHO criteria for the ideal method:
      it is much easier to learn, faster, safer for both surgeons and patients, heals sooner, and
      is more cost effective than any other currently available technique.
Voluntary medical male circumcision (VMMC) is a priority preventive intervention and
      Mozambique is a priority country for VMMC scale-up. PEPFAR recently estimated that one HIV
      infection would be prevented between now and 2025 for every seven circumcisions performed in
      Mozambique. Sofala Province, where the study will be conducted, has an HIV prevalence of 13%
      among men and 18% among women. Approximately 8% of men aged 15-49 in Sofala Province, where
      the study will take place, are currently circumcised.

      In spite of their widely acknowledged drawbacks, open surgical techniques are the only VMMC
      techniques the President's Emergency Plan for AIDS Relief (PEPFAR) program currently allows
      in Africa. According to the Framework for Clinical Evaluation of Devices for Adult Male
      Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more
      devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid
      healing than current methods and/or might entail less risk of HIV transmission in the
      post-operative period; (c) could be performed safely by health-care providers with a minimal
      level of training; and (d) would be cost-effective compared to standard surgical methods for
      male circumcision scale up."

      This proposed randomized controlled trial will provide important data which will inform and
      enable the Mozambican government and PEPFAR to more effectively scale-up circumcision
      services. The investigators postulate that VMMC using the Gomco clamp coupled with tissue
      adhesive meets WHO criteria for the ideal method: it is much easier to learn, faster, safer
      for both surgeons and patients, heals sooner, and is more cost effective than any other
      currently available technique.

      The investigators propose a randomized controlled trial (RCT) comparing this
      minimally-invasive circumcision technique to the open surgical technique:

        -  Gomco clamp with tissue adhesive: 100 men

        -  Open surgical circumcision: 100 men

      The Gomco clamp is an FDA-approved device widely used in the US, but there are few data on
      its use in Africa. Tissue adhesive is widely used in multiple areas of medicine;
      specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue
      adhesives to be superior to suture closure in circumcision in boys. The investigators refer
      to Gomco clamp circumcision coupled with tissue adhesive as a 'new' technique because these
      two independently-validated components have only been coupled in observational studies among
      men, and in randomized controlled trials among pre-pubertal boys, but never before in an RCT
      among adult men. The open surgical method is PEPFAR-approved and will serve as the control
      intervention.

      Population: Men > 18 years of age who desire male circumcision Sample size: 200 (100 men in
      each group) Study design: Randomized controlled trial Intervention: Gomco clamp circumcision
      plus tissue adhesive vs. open surgical circumcision Follow-up visits: 2 days, 7 days, 14 days
      and 28 days. Optional 42 day follow-up if not completely healed by 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intraoperative Duration
time frame: 1 year
description: Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.
measure: Difficulty in Learning and Performing Technique
time frame: 1 year
description: Evaluated by doctor survey, 5 point Likert scale:
Gomco technique is much easier
Gomco technique is easier
Neutral
Open surgical technique is easier
Open surgical technique is much easier
measure: Time Required for Healing
time frame: Within 6 weeks after surgery
description: Time required for healing
measure: Direct Costs
time frame: Within 6 weeks after surgery
description: the cost of labor, supplies and equipment
measure: Pain Experienced
time frame: 2 days after surgery
description: Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)
measure: Overall Patient Satisfaction
time frame: Within 6 weeks after surgery
description: Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.
measure: Cosmetic Result
time frame: Within 6 weeks after surgery
description: Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).
measure: Adverse Events
time frame: 1 yr
description: Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection
arm group label: Open surgical circumcision
arm group type: Active Comparator
description: Open surgical techniques, which are commonly used for circumcision in Mozambique, require good surgical skills and minor complications are common.
arm group label: Gomco clamp with tissue adhesive
arm group type: Experimental
description: Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
intervention type: Procedure
intervention name: Gomco Clamp with Tissue Adhesive
description: According to WHO (2011), the Gomco clamp has "…an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision." Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC.
arm group label: Gomco clamp with tissue adhesive
intervention type: Procedure
intervention name: Open surgical circumcision
description: The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.
arm group label: Open surgical circumcision
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter Millard, MD, PhD
role: Principal Investigator
affiliation: Universidade Catholic de Mozambique
facility: 
country: Mozambique
citation: Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007 Feb 24;369(9562):657-66. doi: 10.1016/S0140-6736(07)60313-4.
PMID: 17321311
citation: Bailey RC, Muga R, Poulussen R, Abicht H. The acceptability of male circumcision to reduce HIV infections in Nyanza Province, Kenya. AIDS Care. 2002 Feb;14(1):27-40. doi: 10.1080/09540120220097919.
PMID: 11798403
citation: Lagarde E, Dirk T, Puren A, Reathe RT, Bertran A. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS. 2003 Jan 3;17(1):89-95. doi: 10.1097/00002030-200301030-00012.
PMID: 12478073
citation: Scott BE, Weiss HA, Viljoen JI. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, Kwazulu-Natal, South Africa. AIDS Care. 2005 Apr;17(3):304-13. doi: 10.1080/09540120412331299744.
PMID: 15832878
citation: Mattson CL, Bailey RC, Muga R, Poulussen R, Onyango T. Acceptability of male circumcision and predictors of circumcision preference among men and women in Nyanza Province, Kenya. AIDS Care. 2005 Feb;17(2):182-94. doi: 10.1080/09540120512331325671.
PMID: 15763713
citation: Halperin DT, Fritz K, McFarland W, Woelk G. Acceptability of adult male circumcision for sexually transmitted disease and HIV prevention in Zimbabwe. Sex Transm Dis. 2005 Apr;32(4):238-9. doi: 10.1097/01.olq.0000149782.47456.5b. No abstract available.
PMID: 15788922
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responsible party type: Principal Investigator
investigator affiliation: Universidade Católica de Moçambique
investigator full name: Dr. Peter Millard
investigator title: Clinical Director of the Health Center
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