Clinical trial NCT03269968: Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
Official title: Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Morbid
Wound Infection
Wound Complication
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Amenity Health, Inc.
First posted: 2017-09-01
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be enrolled in a 1:1 ratio to either Negative Pressure Wound Therapy or standard dressing. Randomization will occur prior to delivery using a computer randomization system.
Primary purpose: PREVENTION

Brief summary: Obese women are more likely have a cesarean delivery and develop subsequent wound complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown to improve surgical wound healing, but this device has not been adequately studied in cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly obese women after cesarean delivery.

Investigators will be randomizing women with a BMI \> 40 kg/m2 in a 1:1 ratio to either NPWT (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a minimum of four days but not to exceed seven days. The standard dressing is typically removed on postoperative day one or two. The primary outcome is a wound complication defined as the formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to 4 weeks postpartum. Investigators will also administer a patient satisfaction survey regarding their wound healing experience.

Detailed description: Obese women are more likely to be delivered by cesarean than normal weight women and are at increased risk for operative morbidity including wound complications. Negative pressure wound therapy (NPWT) has been shown to improve wound healing, decrease the rate of surgical site infection, sero-hematoma formation, and reoperation rates. The potential benefit of NPWT in high-risk wounds after cesarean delivery is unclear. Investigators propose conducting a single-site randomized controlled trial to examine the efficacy of NPWT after cesarean delivery in morbidly obese women (BMI ≥ 40 kg/m2).

Specific aims of the study include determining if NPWT used in morbidly obese women after cesarean delivery improves postoperative wound complication rate and to assess patient satisfaction with NPWT. The primary outcome is a composite wound complication rate defined as having one of the following occur within four weeks of delivery: wound infection, seroma, hematoma, separation, or dehiscence.

Participants will be randomized in a 1:1 ratio to either NPWT or standard surgical dressing. Women receiving NWPT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery. Women randomized to the standard surgical dressing will have a TELFA non-adhesive dressing with a 3M Tegaderm transparent film adhesive dressing. In addition, an abdominal pad (ABD) with foam tape may be applied to provide additional pressure if needed.

The wound will be assessed at the time of dressing removal or hospital discharge and at four weeks postoperative. Participants will also take a patient satisfaction survey regarding wound healing experience at four-week follow-up. For the study, investigators are planning to enroll 482 patients (241 per arm) to demonstrate a decrease in the wound complication rate by 50%. This study will help clinicians better manage obese women in pregnancy and hopefully improve wound outcomes.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index ≥40 kg/m2 at time of delivery
* Delivered by cesarean delivery
* 18 years or later

Exclusion Criteria:

* Chorioamnionitis
* Silver allergy
* Inability to follow up

Primary outcomes:
measure: Composite Wound Complication
timeFrame: Four weeks postpartum
Secondary outcomes:
measure: Patient Survey
timeFrame: Four weeks postpartum
Other outcomes:
measure: Demographic Data
timeFrame: At time time of admission
measure: Maternal Body Mass Index
timeFrame: At time time of admission
measure: Gestational Age at Delivery
timeFrame: At time time of admission
measure: Maternal Comorbidities
timeFrame: At time time of admission
measure: Antenatal Complications
timeFrame: At time time of admission
measure: Number of Previous Cesarean Deliveries
timeFrame: At time time of admission
measure: Indication for Cesarean Delivery
timeFrame: At time time of cesarean delivery
measure: Reason for Admission
timeFrame: At the time of admission
measure: Labor Duration
timeFrame: At the time of cesarean delivery
measure: Endometritis
timeFrame: Four weeks postpartum
measure: Length of Rupture of Membranes
timeFrame: At the time of cesarean delivery
measure: Operative Time
timeFrame: At the time of cesarean delivery
measure: Intraoperative Complication
timeFrame: At the time of cesarean delivery
measure: Type of Skin Incision
timeFrame: At the time of cesarean delivery
measure: Type of Uterine Incision
timeFrame: At the time of cesarean delivery
measure: Type of Fascia Closure
timeFrame: At the time of cesarean delivery
measure: Type of Subcutaneous Closure
timeFrame: At the time of cesarean delivery
measure: Administration of Preoperative Antibiotics
timeFrame: At the time of cesarean delivery
measure: Quantitative Blood Loss
timeFrame: At the time of cesarean delivery
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Rachael T Overcash, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Iqbal N Iqbal, MD
role: PRINCIPAL_INVESTIGATOR
References: