Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery

NCT02799667 | Terminated Results

• 1 other identifier: 11943
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.

Conditions

Obesity; Surgical Site Infections; Wound Complications; Complications; Cesarean Section

Keywords

negative pressure wound therapy; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment

  Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation \>1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.

  2 weeks post partum/post operative period

Secondary Outcomes (5)

• Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment

  2 weeks post partum/post operative period

• Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment

  2 weeks post partum/post operative period

• Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.

  6 weeks post partum/post operative period

• Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively

  6 weeks post partum/post operative period

• Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively

  6 weeks post partum/post operative period

Study Arms (2)

Standard Dressing

ACTIVE COMPARATOR

Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery.

Device: Standard Dressing

Negative Pressure Wound Therapy Dressing

EXPERIMENTAL

Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery.

Device: Negative Pressure Wound Therapy Dressing

Interventions

Standard Dressing DEVICE

Patients are randomized to the standard dressing at the time of fascial closure.

Standard Dressing

Negative Pressure Wound Therapy Dressing DEVICE

Patients are randomized to the NPWT at the time of fascial closure.

Negative Pressure Wound Therapy Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.

You may not qualify if:

• Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI \< 40 kg/m2 will be excluded from this study.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• Peterson AT, Bakaysa SL, Driscoll JM, Kalyanaraman R, House MD. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100410. doi: 10.1016/j.ajogmf.2021.100410. Epub 2021 May 28.

  PMID: 34058423 DERIVED

MeSH Terms

Conditions

Obesity; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Postoperative Complications; Pathologic Processes

Limitations and Caveats

Early termination secondary to slow recruitment.

Results Point of Contact

• Title: Ashley T. Peterson, MD, Study Coordinator
• Organization: Tufts Medical Center

apeterson@tuftsmedicalcenter.org

617-636-5000

Study Officials

• Michael House, MD

  Tufts Medical Center, physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 15, 2016
• Study Start: May 1, 2016
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)