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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03269968
Other study ID # 2017-137
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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