Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

Tufts University

Status: Terminated

Conditions: Wound Complications; Obesity; Complications; Cesarean Section; Surgical Site Infections

Treatments: Device: Negative Pressure Wound Therapy Dressing; Device: Standard Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02799667

11943

Details and patient eligibility

About

The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.

Full description

Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI > 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI >40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.

Exclusion criteria

• Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI < 40 kg/m2 will be excluded from this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Standard Dressing

Active Comparator group

Description:

Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.

Treatment:

Device: Standard Dressing

Negative Pressure Wound Therapy Dressing

Experimental group

Description:

Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.

Treatment:

Device: Negative Pressure Wound Therapy Dressing