Negative Pressure Wound Therapy in Cesarean Section

NCT02289157 | Completed Results FDA Device

• 1 other identifier: STU 042014-047
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .

Conditions

Postoperative Wound Complications

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Wound Complication

  Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.

  Day of surgery to 30 days postoperative

• Number of Participants With Classification of Wound Morbidity

  Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI

  Day of Surgery to 30 days postoperative

Secondary Outcomes (12)

• Length of Postoperative Stay

  Length of Postoperative Stay

• Length of Stay After Readmission

  After dismissal and readmitted within 30 days for wound morbidity

• Number of Patients With Emergency Room Visits After Discharge

  Day of surgery to 30 days postoperative

• Number of Patients With Number of Clinic Visits

  Day of surgery to 30 days postoperative

• Number of Participants With Morbid Outcomes After Delivery

  Day of Surgery to 30 days postoperative

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.

Device: Negative pressure wound therapy

Standard dressing

NO INTERVENTION

After standard cesarean section completed patients will have standard dressing placed.

Interventions

Negative pressure wound therapy DEVICE

Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.

Also known as: Prevena

Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 10 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women with BMI \> 40 undergoing a cesarean delivery at Parkland Health and Hospital System.

You may not qualify if:

• All HIV positive patients will be excluded due to the increased risk of infectious complications in these patients.
• Although patients on anticoagulants can use NPWT, they will be excluded as there may be an increased risk of bleeding in these patients.
• according to the wound therapy manufacturer's instructions patients with:
• fragile skin
• allergy to silver or acrylic adhesives
• a malignancy in the wound bed or margins of the wound bed
• non-enteric and unexplored fistulas
• necrotic tissue with eschar present
• exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction are not candidates for usage of the device.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• KCI USA, Inc: collaborator

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Hussamy DJ, Wortman AC, McIntire DD, Leveno KJ, Casey BM, Roberts SW. Closed Incision Negative Pressure Therapy in Morbidly Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.

  PMID: 31503147 DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Dr. Scott Roberts
• Organization: UTSW Medical Center

scott.roberts@utsouthwestern.edu

214-648-3113

Study Officials

• Scott Roberts, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Placebo Controlled Clinical Trial - Open Label

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: November 13, 2014
• Study Start: January 27, 2015
• Primary Completion: August 30, 2016
• Study Completion: October 21, 2016
• Last Updated: July 2, 2018
• Results First Posted: July 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)