External Negative Pressure Dressing System (ENPDS) vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- incidence of wound dehiscence
Study Overview
Brief Summary
Obesity is associated with increased cesarean section delivery rates and surgical site infections with associated increased post-operative morbidity, post-operative pain and length of hospital stay.
Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to reduce surgical site infections in obese women undergoing cesarean section by immediate postoperative application in clean-contaminated, closed surgical incisions.
Detailed Description
Obesity, defined as body mass index (BMI, calculated as weight (kg)/ [height (m)] 2) of 30 or greater, is a common medical comorbidity of pregnancy affecting one third of reproductive-aged women. Maternal obesity is also a well-recognized risk factor for dysfunctional labor and cesarean delivery with a cesarean section rate of 33% in obese women with BMI of 30 or greater and 43% in women with BMIs of 40 or greater.
Obesity is an independent risk factor for post-operative surgical site infection. The risk of post-cesarean surgical site infection has been shown to double for every 5 unit increase in body mass index (BMI) above 30 kg/m , occurring in about 10% of obese women undergoing caesarean section despite prophylactic strategies (e.g. antibiotics).
This can be explained partly by a decreased blood flow in adipose tissue and an obesity-associated inflammation causing vascular dysfunction, which results in a local hypoxic response. Hypoxia impairs oxidative bacterial killing and leads to an increased risk of surgical site infection.
Wound healing is a sequence of physiologic events that include inflammation, epithelialization, fibroplasia, and maturation. Failure of wound healing at the surgical site can lead to seroma, hematoma, wound dehiscence, incisional hernia and surgical site infection.
Surgical site infection SSI according to The Centers for Disease Control and Prevention is as an infection occurring within 30 days from the operative procedure in the part of the body where the surgery took place, where there is purulent drainage from incision, isolated organisms from the incision, dehiscence or deliberate opening by the surgeon when the patient has at least one sign or symptom of clinical infection: localized pain, edema, erythema, warmth and fever greater than 38 c (unless culture of incision is negative) or there is an abscess or other evidence of infection is found during examination of incision, reoperation, or pathologic or radiologic exam.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 18 or older
- •BMI: 30 or greater
- •undergoing Cesarean section through a Pfannenstiel incision
Exclusion Criteria
- •Prolonged Rupture of membranes >18 hours
- •Intra amniotic infection
- •Severe anemia
- •Vasculopathies as in hypertension/pre-eclampsia, pregestational / gestational diabetes mellitus, smoking and substance abuse
- •Prolonged steroids therapy as in SLE, ITP
- •Intraoperative complications as bladder or bowel injury , placenta previa / accreta, difficult fetal extraction , ovarian cysts, pelvic abscess
- •Intra-abdominal or subcutaneous drain
Arms & Interventions
standard dressing group
patients will receive sterile wound dressing of gauze and tape for 4 days.
External negative pressure dressing system group
patients will receive placement of a sterile dressing of gauze and occlusive adhesive over the closed incision. The dressing's tubing will then be attached to a compact, portable negative-pressure therapy unit (Yuwell 7E-A portable suction unit) that will deliver -80 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
Intervention: External negative pressure dressing system (Yuwell 7E-A portable suction unit) (Device)
Outcomes
Primary Outcomes
incidence of wound dehiscence
Time Frame: till 30 days post operative
separation of the incision line prior to complete healing resulting in an open wound.
Secondary Outcomes
- patient mobility(4 days)
- surgical site infection(30 days post operative)
- post operative pain(till 30 days post operative)
- further need for additional antibiotics(till 30 days post operative)
- length of hospital stay(till 30 days post operative)
- the need for re-admission(till 30 days post operative)
- peri-incision blistering(till 30 days post operative)
Investigators
Dalia Magdy Mokhtar
resident of obstetrics and gynecology
Ain Shams Maternity Hospital