Clinical trial NCT01679379: 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
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Keywords: Cesarean Section
Obese Women
Surgical Site Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Surgical site infection
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Skin closure time
timeFrame: 30 days
Other outcomes:
measure: Postoperative pain
timeFrame: 7 Days
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
name: Gamal F. Mostafa, MD
role: STUDY_DIRECTOR
References: