Wound Infection in Obese Women After Cesarean Delivery

Surgical Site Infection in Obese Women After Cesarean Section; A Randomized Controlled Trial of Absorbable Versus Non Absorbable Sutures for Skin Closure.

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.

Study Overview

• Status: Completed
• Conditions: Surgical Site Infection
• Intervention / Treatment: Procedure: Absorbable suture group; Procedure: Non absorbable suture group

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absorbable suture group; Include women who have their skin closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture].	Procedure: Absorbable suture group; Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]
Active Comparator: Non absorbable suture group; Include women who have their skin closed with subcuticular stitches using [Polypropylene non absorbable monofilament suture].	Procedure: Non absorbable suture group; Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 30 days of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin closure time	Complete wound closure	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Women specify their pain level according to visual analogue scale (VAS)	7 Days

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Gamal F. Mostafa, MD, Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Estimate): May 24, 2013
• Last Update Submitted That Met QC Criteria: May 23, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Cesarean Section; Obese Women
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: ASU-07-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No