xml: <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/NCT06042088</url>
    </required_header>
    <id_info>
      <org_study_id>2023/170</org_study_id>
      <nct_id>NCT06042088</nct_id>
    </id_info>
    <brief_title>Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity</brief_title>
    <official_title>Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Medipol University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Medipol University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial aims to test the effect of double surgical gloves worn in different sizes&#xD;
        on the surgical team's comfort, sensitivity, and dexterity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of using surgical gloves is to create a protective barrier against blood-borne&#xD;
        pathogens. According to studies, gloves can puncture during surgical procedures. Many studies&#xD;
        recommend wearing double gloves. However, the World Health Organization reported that in the&#xD;
        guideline for surgical site infections published in 2018, there is not enough evidence for&#xD;
        wearing double or single gloves to prevent surgical site infections. However, he recommends&#xD;
        that the surgical team prefer to use double gloves to protect themselves against punctures.&#xD;
  &#xD;
        Although wearing double gloves is considered to be positive in terms of patient and employee&#xD;
        safety, it is not preferred by the surgical team in some cases. The sense of touch and&#xD;
        sensitivity of the human hand is at the center of surgical procedures. Finger pulp is&#xD;
        extremely sensitive and contains many sensory receptors. Placing a barrier, such as a glove,&#xD;
        between these sensory receptors and the touched surface may prevent tactile sensitivity in&#xD;
        surgical applications. In addition to the advantages of double gloves in terms of patient and&#xD;
        employee safety, there are disadvantages such as reduced dexterity and touch sensitivity. In&#xD;
        the literature, it has been determined that there are few and old studies examining the&#xD;
        effects of double glove use on performance and comfort. Therefore, this study, it was aimed&#xD;
        to compare the effects of double surgical gloves worn in different procedures or usage habits&#xD;
        (double gloves, large and small gloves) on the comfort, sensitivity, and dexterity of the&#xD;
        surgical team.&#xD;
  &#xD;
        The study will conduct as a prospective randomized controlled trial. After obtaining verbal&#xD;
        and written consent from the participant, the study will conduct with various data collection&#xD;
        forms. These forms are; the introductory information form, surgical glove evaluation form,&#xD;
        and Visual Analogue Scale. Participants will randomize. After randomization, participants&#xD;
        will be included in one of four groups. All procedures will be applied to participants in all&#xD;
        groups. Group I (n=20), Group II (n=20), Group III (n=20), Group IV (n=20). Procedure A:&#xD;
        Double gloves, participants will wear both gloves in their surgical glove size. Procedure B:&#xD;
        Double gloves, participants will wear their own glove number and half a size bigger glove on&#xD;
        top. Procedure C: Double gloves, participants will wear a half-size big glove and their own&#xD;
        glove number on top. Procedure D: Participants will wear one glove (control procedure). Open&#xD;
        surgeries with a duration of 90-120 minutes will be preferred for evaluation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 3, 2023</start_date>
    <completion_date type="Anticipated">November 3, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 3, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from comfort, sensitivity, and dexterity after 90-120 min.</measure>
      <time_frame>After 90-120 minutes</time_frame>
      <description>In this section, the degree of comfort, sensitivity, and dexterity. This status will be evaluated with Visual Analogue Scale. In Visual Analogue Scale we use between 0-10 point (0= most uncomfortable/ most insensitivity/ most indexterity, 10=most comfort/ most sensitivity/ most dexterity).</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Surgical Gloves</condition>
    <arm_group>
      <arm_group_label>Double Gloves:Regular Size</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Double Gloves: Regular Size and Half-Size Bigger</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Double Gloves: Half-Size Bigger and Regular Size</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>One Glove</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Procedure D: Participants will wear only one glove.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Regular Size Glove and Bigger One</intervention_name>
      <description>Different sizes of surgical gloves will be worn by participants</description>
      <arm_group_label>Double Gloves: Half-Size Bigger and Regular Size</arm_group_label>
      <arm_group_label>Double Gloves: Regular Size and Half-Size Bigger</arm_group_label>
      <arm_group_label>Double Gloves:Regular Size</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Taking part in the surgical team Six months or more of surgical experience&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Latex allergic&#xD;
        </textblock>
      </criteria>
      <gender>All</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>Neslihan Ilkaz</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara Medipol University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Neslihan Ilkaz</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Guo YP, Wong PM, Li Y, Or PP. Is double-gloving really protective? A comparison between the glove perforation rate among perioperative nurses with single and double gloves during surgery. Am J Surg. 2012 Aug;204(2):210-5. doi: 10.1016/j.amjsurg.2011.08.017. Epub 2012 Feb 17.</citation>
      <PMID>22342011</PMID>
    </reference>
    <reference>
      <citation>Bouvet E, Pellissier G, Abiteboul D, L'Heriteau F; Group for the Prevention of Occupational Infections in Healthcare Workers. Is double gloving an effective barrier to protect surgeons against blood exposure due to needlestick injury? Infect Control Hosp Epidemiol. 2009 Sep;30(9):928-9; author reply 929. doi: 10.1086/599309. No abstract available.</citation>
      <PMID>19653826</PMID>
    </reference>
    <reference>
      <citation>Schmauss D, Megerle K, Weinzierl A, Agua K, Cerny M, Schmauss V, Lohmeyer JA, Machens HG, Erne H. Microsurgeons do better--tactile training might prevent the age-dependent decline of the sensibility of the hand. J Peripher Nerv Syst. 2015 Dec;20(4):392-6. doi: 10.1111/jns.12144.</citation>
      <PMID>26306813</PMID>
    </reference>
    <reference>
      <citation>Mylon P, Carre MJ, Martin N, Lewis R. How do gloves affect cutaneous sensibility in medical practice? Two new applied tests. Proc Inst Mech Eng H. 2017 Jan;231(1):28-39. doi: 10.1177/0954411916679199. Epub 2016 Nov 23.</citation>
      <PMID>27881806</PMID>
    </reference>
    <reference>
      <citation>8. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Erişim adresi: https://www.who.int/publications/i/item/global-guidelines-for-the-prevention-of-surgical-site-infection-2nd-ed</citation>
    </reference>
    <reference>
      <citation>Basak T, Sahin G, Demirtas A. Comparison of surgical gloves: perforation, satisfaction and manual dexterity. Int J Occup Saf Ergon. 2022 Jun;28(2):1160-1166. doi: 10.1080/10803548.2021.1875636. Epub 2021 Mar 2.</citation>
      <PMID>33433290</PMID>
    </reference>
    <reference>
      <citation>Han CD, Kim J, Moon SH, Lee BH, Kwon HM, Park KK. A randomized prospective study of glove perforation in orthopaedic surgery: is a thick glove more effective? J Arthroplasty. 2013 Dec;28(10):1878-81. doi: 10.1016/j.arth.2013.05.007. Epub 2013 Jun 6.</citation>
      <PMID>23747130</PMID>
    </reference>
    <reference>
      <citation>Moog P, Schulz M, Betzl J, Schmauss D, Lohmeyer JA, Machens HG, Megerle K, Erne HC. Do your surgical glove characteristics and wearing habits affect your tactile sensibility? Ann Med Surg (Lond). 2020 Aug 8;57:281-286. doi: 10.1016/j.amsu.2020.08.002. eCollection 2020 Sep. Erratum In: Ann Med Surg (Lond). 2021 Aug 21;69:102743.</citation>
      <PMID>32904254</PMID>
    </reference>
    <reference>
      <citation>Zhang Z, Gao X, Ruan X, Zheng B. Effectiveness of double-gloving method on prevention of surgical glove perforations and blood contamination: A systematic review and meta-analysis. J Adv Nurs. 2021 Sep;77(9):3630-3643. doi: 10.1111/jan.14824. Epub 2021 Mar 17.</citation>
      <PMID>33733484</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Medipol University</investigator_affiliation>
      <investigator_full_name>Neslihan Ilkaz</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Surgical gloves</keyword>
    <keyword>Comfort</keyword>
    <keyword>Dexterity</keyword>
    <keyword>Sensitivity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042088
  org study id: 2023/170
  nct id: NCT06042088
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial aims to test the effect of double surgical gloves worn in different sizes
        on the surgical team's comfort, sensitivity, and dexterity.
  The purpose of using surgical gloves is to create a protective barrier against blood-borne
        pathogens. According to studies, gloves can puncture during surgical procedures. Many studies
        recommend wearing double gloves. However, the World Health Organization reported that in the
        guideline for surgical site infections published in 2018, there is not enough evidence for
        wearing double or single gloves to prevent surgical site infections. However, he recommends
        that the surgical team prefer to use double gloves to protect themselves against punctures.
  
        Although wearing double gloves is considered to be positive in terms of patient and employee
        safety, it is not preferred by the surgical team in some cases. The sense of touch and
        sensitivity of the human hand is at the center of surgical procedures. Finger pulp is
        extremely sensitive and contains many sensory receptors. Placing a barrier, such as a glove,
        between these sensory receptors and the touched surface may prevent tactile sensitivity in
        surgical applications. In addition to the advantages of double gloves in terms of patient and
        employee safety, there are disadvantages such as reduced dexterity and touch sensitivity. In
        the literature, it has been determined that there are few and old studies examining the
        effects of double glove use on performance and comfort. Therefore, this study, it was aimed
        to compare the effects of double surgical gloves worn in different procedures or usage habits
        (double gloves, large and small gloves) on the comfort, sensitivity, and dexterity of the
        surgical team.
  
        The study will conduct as a prospective randomized controlled trial. After obtaining verbal
        and written consent from the participant, the study will conduct with various data collection
        forms. These forms are; the introductory information form, surgical glove evaluation form,
        and Visual Analogue Scale. Participants will randomize. After randomization, participants
        will be included in one of four groups. All procedures will be applied to participants in all
        groups. Group I (n=20), Group II (n=20), Group III (n=20), Group IV (n=20). Procedure A:
        Double gloves, participants will wear both gloves in their surgical glove size. Procedure B:
        Double gloves, participants will wear their own glove number and half a size bigger glove on
        top. Procedure C: Double gloves, participants will wear a half-size big glove and their own
        glove number on top. Procedure D: Participants will wear one glove (control procedure). Open
        surgeries with a duration of 90-120 minutes will be preferred for evaluation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change from comfort, sensitivity, and dexterity after 90-120 min.
  time frame: After 90-120 minutes
  description: In this section, the degree of comfort, sensitivity, and dexterity. This status will be evaluated with Visual Analogue Scale. In Visual Analogue Scale we use between 0-10 point (0= most uncomfortable/ most insensitivity/ most indexterity, 10=most comfort/ most sensitivity/ most dexterity).
  arm group label: Double Gloves:Regular Size
  arm group type: Experimental
  description: Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.
  arm group label: Double Gloves: Regular Size and Half-Size Bigger
  arm group type: Experimental
  description: Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top
  arm group label: Double Gloves: Half-Size Bigger and Regular Size
  arm group type: Experimental
  description: Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.
  arm group label: One Glove
  arm group type: No Intervention
  description: Procedure D: Participants will wear only one glove.
  intervention type: Other
  intervention name: Regular Size Glove and Bigger One
  description: Different sizes of surgical gloves will be worn by participants
  arm group label: Double Gloves: Half-Size Bigger and Regular Size
  arm group label: Double Gloves: Regular Size and Half-Size Bigger
  arm group label: Double Gloves:Regular Size
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Neslihan Ilkaz
  role: Principal Investigator
  affiliation: Ankara Medipol University
  facility: 
  country: Turkey
  citation: Guo YP, Wong PM, Li Y, Or PP. Is double-gloving really protective? A comparison between the glove perforation rate among perioperative nurses with single and double gloves during surgery. Am J Surg. 2012 Aug;204(2):210-5. doi: 10.1016/j.amjsurg.2011.08.017. Epub 2012 Feb 17.
  PMID: 22342011
  citation: Bouvet E, Pellissier G, Abiteboul D, L'Heriteau F; Group for the Prevention of Occupational Infections in Healthcare Workers. Is double gloving an effective barrier to protect surgeons against blood exposure due to needlestick injury? Infect Control Hosp Epidemiol. 2009 Sep;30(9):928-9; author reply 929. doi: 10.1086/599309. No abstract available.
  PMID: 19653826
  citation: Schmauss D, Megerle K, Weinzierl A, Agua K, Cerny M, Schmauss V, Lohmeyer JA, Machens HG, Erne H. Microsurgeons do better--tactile training might prevent the age-dependent decline of the sensibility of the hand. J Peripher Nerv Syst. 2015 Dec;20(4):392-6. doi: 10.1111/jns.12144.
  PMID: 26306813
  citation: Mylon P, Carre MJ, Martin N, Lewis R. How do gloves affect cutaneous sensibility in medical practice? Two new applied tests. Proc Inst Mech Eng H. 2017 Jan;231(1):28-39. doi: 10.1177/0954411916679199. Epub 2016 Nov 23.
  PMID: 27881806
  citation: 8. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Erişim adresi: https://www.who.int/publications/i/item/global-guidelines-for-the-prevention-of-surgical-site-infection-2nd-ed
  citation: Basak T, Sahin G, Demirtas A. Comparison of surgical gloves: perforation, satisfaction and manual dexterity. Int J Occup Saf Ergon. 2022 Jun;28(2):1160-1166. doi: 10.1080/10803548.2021.1875636. Epub 2021 Mar 2.
  PMID: 33433290
  citation: Han CD, Kim J, Moon SH, Lee BH, Kwon HM, Park KK. A randomized prospective study of glove perforation in orthopaedic surgery: is a thick glove more effective? J Arthroplasty. 2013 Dec;28(10):1878-81. doi: 10.1016/j.arth.2013.05.007. Epub 2013 Jun 6.
  PMID: 23747130
  citation: Moog P, Schulz M, Betzl J, Schmauss D, Lohmeyer JA, Machens HG, Megerle K, Erne HC. Do your surgical glove characteristics and wearing habits affect your tactile sensibility? Ann Med Surg (Lond). 2020 Aug 8;57:281-286. doi: 10.1016/j.amsu.2020.08.002. eCollection 2020 Sep. Erratum In: Ann Med Surg (Lond). 2021 Aug 21;69:102743.
  PMID: 32904254
  citation: Zhang Z, Gao X, Ruan X, Zheng B. Effectiveness of double-gloving method on prevention of surgical glove perforations and blood contamination: A systematic review and meta-analysis. J Adv Nurs. 2021 Sep;77(9):3630-3643. doi: 10.1111/jan.14824. Epub 2021 Mar 17.
  PMID: 33733484
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Medipol University
  investigator full name: Neslihan Ilkaz
  investigator title: Assistant Professor
  mesh term: Hypersensitivity