Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery

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.

Study Overview

• Status: Terminated
• Conditions: Obesity, Morbid; Wound Infection; Wound Complication
• Intervention / Treatment: Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System); Device: Standard dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Negative pressure wound therapy (NPWT); Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.	Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System); After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.
PLACEBO_COMPARATOR: Standard dressing	Device: Standard dressing; After cesarean delivery, women in the intervention group will receive standard dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Wound Complication	Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence	Four weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Survey	Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.	Four weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Data	Age, race/ethnicity, parity	At time time of admission
Maternal Body Mass Index	Prepregnancy and at the time of delivery	At time time of admission
Gestational Age at Delivery	We were unable to adequately recruit for this study. Study was closed.	At time time of admission
Maternal Comorbidities	Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism	At time time of admission
Antenatal Complications	Gestational diabetes, preeclampsia	At time time of admission
Number of Previous Cesarean Deliveries	We were unable to adequately recruit for this study. Study was closed.	At time time of admission
Indication for Cesarean Delivery	Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean	At time time of cesarean delivery
Reason for Admission	Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)	At the time of admission
Labor Duration	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Endometritis	We were unable to adequately recruit for this study. Study was closed.	Four weeks postpartum
Length of Rupture of Membranes	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Operative Time	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Intraoperative Complication	Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy	At the time of cesarean delivery
Type of Skin Incision	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Type of Uterine Incision	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Type of Fascia Closure	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Type of Subcutaneous Closure	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Administration of Preoperative Antibiotics	Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other	At the time of cesarean delivery
Quantitative Blood Loss	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Amenity Health, Inc.
• Investigators: Principal Investigator: Rachael T Overcash, MD, MPH, MedStar Washington Hospital Center; Principal Investigator: Iqbal N Iqbal, MD, MedStar Washington Hospital Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (ACTUAL): September 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Wounds and Injuries; Obesity, Morbid; Wound Infection
• Other Study ID Numbers: 2017-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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