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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03269968
• Other study ID #: 2017-137
• Status: Terminated
• Phase: N/A
• Start date: October 3, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Wound Complication
• Wound Infection
• Wounds and Injuries

Intervention

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.
• Standard dressing
After cesarean delivery, women in the intervention group will receive standard dressing.

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Amenity Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic Data	Age, race/ethnicity, parity	At time time of admission
Other	Maternal Body Mass Index	Prepregnancy and at the time of delivery	At time time of admission
Other	Gestational Age at Delivery	We were unable to adequately recruit for this study. Study was closed.	At time time of admission
Other	Maternal Comorbidities	Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism	At time time of admission
Other	Antenatal Complications	Gestational diabetes, preeclampsia	At time time of admission
Other	Number of Previous Cesarean Deliveries	We were unable to adequately recruit for this study. Study was closed.	At time time of admission
Other	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
Other	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
Other	Labor Duration	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Endometritis	We were unable to adequately recruit for this study. Study was closed.	Four weeks postpartum
Other	Length of Rupture of Membranes	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Operative Time	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Intraoperative Complication	Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy	At the time of cesarean delivery
Other	Type of Skin Incision	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Type of Uterine Incision	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Type of Fascia Closure	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Type of Subcutaneous Closure	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Other	Administration of Preoperative Antibiotics	Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other	At the time of cesarean delivery
Other	Quantitative Blood Loss	We were unable to adequately recruit for this study. Study was closed.	At the time of cesarean delivery
Primary	Composite Wound Complication	Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence	Four weeks postpartum
Secondary	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