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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269968
Recruitment Status : Terminated (Recruitment difficulty)
First Posted : September 1, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Amenity Health, Inc.
Information provided by (Responsible Party):
Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE August 30, 2017
First Posted Date  ICMJE September 1, 2017
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE October 3, 2017
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
Composite wound complication [ Time Frame: Four weeks postpartum ]
Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
Patient survey [ Time Frame: Four weeks postpartum ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2017)
Patient survey [ Time Frame: Four weeks postpartum ]
Through patient surveys administered prior to hospital discharge and at four weeks post-operative we will evaluate patient satisfaction with their wound healing. Satisfactory measures will include how well they think their 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 we will assess the ease of use, comfort, and perception of its efficacy.
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2017)
  • Demographic data [ Time Frame: At time time of admission ]
    Age, race/ethnicity, parity
  • Maternal body mass index [ Time Frame: At time time of admission ]
    Prepregnancy and at the time of delivery
  • Gestational age at delivery [ Time Frame: At time time of admission ]
  • Maternal comorbidities [ Time Frame: At time time of admission ]
    Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism
  • Antenatal complications [ Time Frame: At time time of admission ]
    Gestational diabetes, preeclampsia
  • Number of previous cesarean deliveries [ Time Frame: At time time of admission ]
  • Indication for cesarean delivery [ Time Frame: At time time of cesarean delivery ]
    Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean
  • Reason for admission [ Time Frame: At the time of admission ]
    Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)
  • Labor duration [ Time Frame: At the time of cesarean delivery ]
  • Endometritis [ Time Frame: Four weeks postpartum ]
  • Length of rupture of membranes [ Time Frame: At the time of cesarean delivery ]
  • Operative time [ Time Frame: At the time of cesarean delivery ]
  • Intraoperative complication [ Time Frame: At the time of cesarean delivery ]
    Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy
  • Type of skin incision [ Time Frame: At the time of cesarean delivery ]
  • Type of uterine incision [ Time Frame: At the time of cesarean delivery ]
  • Type of fascia closure [ Time Frame: At the time of cesarean delivery ]
  • Type of subcutaneous closure [ Time Frame: At the time of cesarean delivery ]
  • Administration of preoperative antibiotics [ Time Frame: At the time of cesarean delivery ]
    Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other
  • Quantitative blood loss [ Time Frame: At the time of cesarean delivery ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
Official Title  ICMJE Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity, Morbid
  • Wound Infection
  • Wound Complication
Intervention  ICMJE
  • 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.
  • Device: Standard dressing
    After cesarean delivery, women in the intervention group will receive standard dressing.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System)
  • Placebo Comparator: Standard dressing
    Standard dressing
    Intervention: Device: Standard dressing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2017)
482
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03269968
Other Study ID Numbers  ICMJE 2017-137
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medstar Health Research Institute
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Amenity Health, Inc.
Investigators  ICMJE
Principal Investigator: Rachael T Overcash, MD, MPH Medstar Washington Hospital Center
Principal Investigator: Iqbal N Iqbal, MD Medstar Washington Hospital Center
PRS Account Medstar Health Research Institute
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP