<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/NCT01679379</url>
  </required_header>
  <id_info>
    <org_study_id>ASU-07-2012</org_study_id>
    <nct_id>NCT01679379</nct_id>
  </id_info>
  <brief_title>Wound Infection in Obese Women After Cesarean Delivery</brief_title>
  <official_title>Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the surgical site infection rate and patient&#xD;
      satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean&#xD;
      section in obese women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cesarean section (CS) is the commonest major operation performed on women in the world.&#xD;
      Approximately one in 4 women in the United States is delivered by cesarean section, and it is&#xD;
      well established that operative abdominal delivery is associated with a significant risk of&#xD;
      infection compared with vaginal delivery. These risks are increased with preexisting&#xD;
      operative site infection, breaks in sterile technique, prolonged preoperative admissions that&#xD;
      may result in colonization with resistant microbes, prolonged operative duration, use of&#xD;
      electrocautery, obesity, advanced age, inadequate host immunocompetence.&#xD;
&#xD;
      Obese women may have increased susceptibility to infections because of the effects of obesity&#xD;
      on the immune system, skin barriers, wound healing, mobility, and coexisting chronic diseases&#xD;
      including diabetes, which could increase infection risk by itself. Cohort studies have shown&#xD;
      that women with a body mass index (BMI)&gt;30kg/m^2 have a two to three folds increased risk of&#xD;
      post cesarean infections, such as wound infection, urinary tract infection UTI),&#xD;
      endometritis, or pneumonia, compared with non-obese women. Other studies found that obesity&#xD;
      doubled the risk specifically for post-cesarean wound infection.&#xD;
&#xD;
      Wound complications are a major source of morbidity after CS and contribute to prolonged&#xD;
      hospital stay and rates of readmission. Age, (BMI), length of incision, and timing of&#xD;
      prophylactic antibiotic administration have all been associated with post cesarean surgical&#xD;
      site infection (SSI).&#xD;
&#xD;
      A surgical site infection is an infection that occurs after surgery in the part of the body&#xD;
      where the surgery took place. SSI can sometimes be superficial infections involving the skin&#xD;
      only. Other surgical site infections are more serious and can involve tissues under the skin,&#xD;
      organs, or implanted material. SSI has a great impact on the economy and health care&#xD;
      resources. Infection has always been a feature of modern surgery and continues to be a&#xD;
      significant problem for health care practitioners across the world.&#xD;
&#xD;
      The ideal skin closure would be safe and effective, associated with minimal patient&#xD;
      discomfort, and have a good cosmetic result. It would also be inexpensive and require fewer&#xD;
      health care resources by being fast and easy to apply, require minimal follow-up evaluation,&#xD;
      and be associated with a low rate of complications.&#xD;
&#xD;
      Methods for closing the skin at the time of cesarean delivery include stainless steel&#xD;
      staples, subcuticular absorbable staples, subcuticular suture, adhesive closure strips, and&#xD;
      tissue adhesives (cyanoacrylates). Each of the methods has its postulated benefits for wound&#xD;
      outcomes; however, none of these have been compared in a prospective trial.&#xD;
&#xD;
      The role of skin closure suture material on wound complication rates in Obstetrics is poorly&#xD;
      studied. And when we are talking about obese patients we did not find any recommendation&#xD;
      regarding the suture material of skin closure although most of Obstetricians use different&#xD;
      sutures materials.&#xD;
&#xD;
      Does closure of skin by absorbable compared to non absorbable suture affect the rate of&#xD;
      surgical site infection in obese patients undergoing caesarian section? Our hypothesis is&#xD;
      that no difference between absorbable compared to non absorbable suture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>Within 30 days of surgery</time_frame>
    <description>Diagnosis consists of infection of an anatomic plane by one of the following manifestations: collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence(Wound separation was defined as any separation of the wound that was identified as such by the patient or the medical record and varied in size from small skin defects to separation of the entire wound; or positive culture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin closure time</measure>
    <time_frame>30 days</time_frame>
    <description>Complete wound closure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>7 Days</time_frame>
    <description>Women specify their pain level according to visual analogue scale (VAS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Absorbable suture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture].</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non absorbable suture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture].</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Absorbable suture group</intervention_name>
    <description>Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]</description>
    <arm_group_label>Absorbable suture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non absorbable suture group</intervention_name>
    <description>Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture</description>
    <arm_group_label>Non absorbable suture group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant female in child bearing period&#xD;
&#xD;
          -  Mode of delivery is by cesarean section (CS)&#xD;
&#xD;
          -  Obese women, Body Mass Index (BMI) &gt;30kg/m^2&#xD;
&#xD;
          -  Viable fetus&#xD;
&#xD;
          -  Gestational age &gt;34 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemoglobin (Hb)less than 10g/dl.&#xD;
&#xD;
          -  Previous laparotomy other than CS.&#xD;
&#xD;
          -  Rupture of membranes for more than 12 hours.&#xD;
&#xD;
          -  Presence of signs of systemic or local infection on admission (e.g. fever, tender&#xD;
             uterus).&#xD;
&#xD;
          -  Prolonged operative time &gt;90 minutes.&#xD;
&#xD;
          -  Previous two CS or more.&#xD;
&#xD;
          -  Autoimmune disease.&#xD;
&#xD;
          -  Immune suppressive disease.&#xD;
&#xD;
          -  Corticosteroid medications.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gamal F. Mostafa, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Obstetrics &amp; Gynecology Faculty of Medicine, Ain Shams University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain shams university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>May 23, 2013</last_update_submitted>
  <last_update_submitted_qc>May 23, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed Ellaithy</investigator_full_name>
    <investigator_title>Lecturer of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <keyword>Cesarean Section</keyword>
  <keyword>Obese Women</keyword>
  <keyword>Surgical Site Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01679379
org study id: ASU-07-2012
nct id: NCT01679379
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the surgical site infection rate and patient
      satisfaction for absorbable versus non absorbable suture in closure of skin at cesarean
      section in obese women.
Cesarean section (CS) is the commonest major operation performed on women in the world.
      Approximately one in 4 women in the United States is delivered by cesarean section, and it is
      well established that operative abdominal delivery is associated with a significant risk of
      infection compared with vaginal delivery. These risks are increased with preexisting
      operative site infection, breaks in sterile technique, prolonged preoperative admissions that
      may result in colonization with resistant microbes, prolonged operative duration, use of
      electrocautery, obesity, advanced age, inadequate host immunocompetence.

      Obese women may have increased susceptibility to infections because of the effects of obesity
      on the immune system, skin barriers, wound healing, mobility, and coexisting chronic diseases
      including diabetes, which could increase infection risk by itself. Cohort studies have shown
      that women with a body mass index (BMI)>30kg/m^2 have a two to three folds increased risk of
      post cesarean infections, such as wound infection, urinary tract infection UTI),
      endometritis, or pneumonia, compared with non-obese women. Other studies found that obesity
      doubled the risk specifically for post-cesarean wound infection.

      Wound complications are a major source of morbidity after CS and contribute to prolonged
      hospital stay and rates of readmission. Age, (BMI), length of incision, and timing of
      prophylactic antibiotic administration have all been associated with post cesarean surgical
      site infection (SSI).

      A surgical site infection is an infection that occurs after surgery in the part of the body
      where the surgery took place. SSI can sometimes be superficial infections involving the skin
      only. Other surgical site infections are more serious and can involve tissues under the skin,
      organs, or implanted material. SSI has a great impact on the economy and health care
      resources. Infection has always been a feature of modern surgery and continues to be a
      significant problem for health care practitioners across the world.

      The ideal skin closure would be safe and effective, associated with minimal patient
      discomfort, and have a good cosmetic result. It would also be inexpensive and require fewer
      health care resources by being fast and easy to apply, require minimal follow-up evaluation,
      and be associated with a low rate of complications.

      Methods for closing the skin at the time of cesarean delivery include stainless steel
      staples, subcuticular absorbable staples, subcuticular suture, adhesive closure strips, and
      tissue adhesives (cyanoacrylates). Each of the methods has its postulated benefits for wound
      outcomes; however, none of these have been compared in a prospective trial.

      The role of skin closure suture material on wound complication rates in Obstetrics is poorly
      studied. And when we are talking about obese patients we did not find any recommendation
      regarding the suture material of skin closure although most of Obstetricians use different
      sutures materials.

      Does closure of skin by absorbable compared to non absorbable suture affect the rate of
      surgical site infection in obese patients undergoing caesarian section? Our hypothesis is
      that no difference between absorbable compared to non absorbable suture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Surgical site infection
time frame: Within 30 days of surgery
description: Diagnosis consists of infection of an anatomic plane by one of the following manifestations: collection; inflammatory signs (pain, tenderness, edema, redness); dehiscence(Wound separation was defined as any separation of the wound that was identified as such by the patient or the medical record and varied in size from small skin defects to separation of the entire wound; or positive culture.
measure: Skin closure time
time frame: 30 days
description: Complete wound closure
measure: Postoperative pain
time frame: 7 Days
description: Women specify their pain level according to visual analogue scale (VAS)
arm group label: Absorbable suture group
arm group type: Active Comparator
description: Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture].
arm group label: Non absorbable suture group
arm group type: Active Comparator
description: Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture].
intervention type: Procedure
intervention name: Absorbable suture group
description: Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]
arm group label: Absorbable suture group
intervention type: Procedure
intervention name: Non absorbable suture group
description: Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture
arm group label: Non absorbable suture group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Gamal F. Mostafa, MD
role: Study Director
affiliation: Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed Ellaithy
investigator title: Lecturer of Obstetrics & Gynecology
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection