Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Hospital, Hospital |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/11/2017 |
| Start Date: | October 3, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Tetsuya Kawakita, MD |
| Email: | tetsuya.x.kawakita@medstar.net |
| Phone: | 2028773067 |
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.
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.
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.
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.
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
We found this trial at
1
site
Washington, District of Columbia
Principal Investigator: Rachael Overcash, MD, MPH
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