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Wound Infection in Obese Women After Cesarean Delivery

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Absorbable suture group
Non absorbable suture group
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring Cesarean Section, Obese Women, Surgical Site Infection

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant female in child bearing period
  • Mode of delivery is by cesarean section (CS)
  • Obese women, Body Mass Index (BMI) >30kg/m^2
  • Viable fetus
  • Gestational age >34 weeks

Exclusion Criteria:

  • Hemoglobin (Hb)less than 10g/dl.
  • Previous laparotomy other than CS.
  • Rupture of membranes for more than 12 hours.
  • Presence of signs of systemic or local infection on admission (e.g. fever, tender uterus).
  • Prolonged operative time >90 minutes.
  • Previous two CS or more.
  • Autoimmune disease.
  • Immune suppressive disease.
  • Corticosteroid medications.

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Absorbable suture group

Non absorbable suture group

Arm Description

Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture].

Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture].

Outcomes

Primary Outcome Measures

Surgical site infection
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.

Secondary Outcome Measures

Skin closure time
Complete wound closure

Full Information

First Posted
September 3, 2012
Last Updated
May 23, 2013
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT01679379
Brief Title
Wound Infection in Obese Women After Cesarean Delivery
Official Title
Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Cesarean Section, Obese Women, Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorbable suture group
Arm Type
Active Comparator
Arm Description
Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture].
Arm Title
Non absorbable suture group
Arm Type
Active Comparator
Arm Description
Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture].
Intervention Type
Procedure
Intervention Name(s)
Absorbable suture group
Intervention Description
Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]
Intervention Type
Procedure
Intervention Name(s)
Non absorbable suture group
Intervention Description
Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture
Primary Outcome Measure Information:
Title
Surgical site infection
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.
Time Frame
Within 30 days of surgery
Secondary Outcome Measure Information:
Title
Skin closure time
Description
Complete wound closure
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Postoperative pain
Description
Women specify their pain level according to visual analogue scale (VAS)
Time Frame
7 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant female in child bearing period Mode of delivery is by cesarean section (CS) Obese women, Body Mass Index (BMI) >30kg/m^2 Viable fetus Gestational age >34 weeks Exclusion Criteria: Hemoglobin (Hb)less than 10g/dl. Previous laparotomy other than CS. Rupture of membranes for more than 12 hours. Presence of signs of systemic or local infection on admission (e.g. fever, tender uterus). Prolonged operative time >90 minutes. Previous two CS or more. Autoimmune disease. Immune suppressive disease. Corticosteroid medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal F. Mostafa, MD
Organizational Affiliation
Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain shams university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Wound Infection in Obese Women After Cesarean Delivery

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