Negative Pressure Wound Therapy in Cesarean Section (NPWTCS)

Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean

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 .

Study Overview

• Status: Completed
• Conditions: Postoperative Wound Complications
• Intervention / Treatment: Device: Negative pressure wound therapy

Detailed Description

This will be a prospective, randomized, controlled trial of pregnant women who present for prenatal care at Parkland Health and Hospital System. The participants will be limited to women undergoing a cesarean section who are high risk for wound complications: all patients with a BMI > 40 undergoing cesarean section.

The primary outcome will be wound complication defined as wound disruption or wound infection. A wound disruption will be defined as the partial or complete opening of the deep subcutaneous space, not to include superficial skin separation. Underlying causes will include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as a physician diagnosis of wound infection with erythema and warmth extending beyond the immediate area adjacent to the incision and requiring treatment with antibiotics.

All patients with a BMI > 40 undergoing scheduled cesarean section and patients with a BMI >40 who are admitted in labor will be approached to participate in the study. If patients meeting this criteria undergo cesarean section, they will be randomized to negative pressure wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics, surgical technique, and post-operative care will not differ from current standard of care. All patients randomized will be included in the study.

All study participants will have the thickness of their subcutaneous tissue measured with a sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system placed over her incision per the manufacturer's protocol. All patients randomized to standard dressing will have the customary dressing of gauze and surgical tape placed over her incision.

The investigators will be utilizing a single use negative pressure wound therapy system for the study. 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.

All randomized patients will undergo an examination of their incision by a research physician or nurse prior to discharge. The NPWT will be removed prior to discharge or on post-operative day seven, whichever comes first. All postpartum patients who undergo a cesarean delivery are inpatients until at least post-operative day three and will continue use of NPWT until day of discharge. In patients randomized to a standard dressing, the dressing will be removed prior to discharge per current standard of care.

All randomized patients will also undergo a 2 week post-operative incisional examination by a research physician or nurse at the obstetrical complications clinic. Patients will be followed until 30 days postpartum for any wound complications to include wound infection (superficial and deep), readmission to the hospital, re-operation for wound complications, hematoma, seroma, dehiscence, superficial infection requiring antibiotics, or additional clinical evaluations for wound care in the emergency room or clinic setting. A research physician or nurse will contact each after at least 30 days post-operative to confirm the patients' status and ensure no evaluations, admissions, or interventions were done at outside facilities.

Subjects will exit the study if they are unable to complete the post-operative visit or withdrawal consent for participation.

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any patient not meeting inclusion criteria will be deemed ineligible.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy; After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.	Device: Negative pressure wound therapy; 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.; Other Names: Prevena
No Intervention: Standard dressing; After standard cesarean section completed patients will have standard dressing placed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Postoperative Stay	Number of Days in Hospital after Initial Surgery	Length of Postoperative Stay
Length of Stay After Readmission	Number of days in hospital after readmission for wound morbidity	After dismissal and readmitted within 30 days for wound morbidity
Number of Patients With Emergency Room Visits After Discharge	Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.	Day of surgery to 30 days postoperative
Number of Patients With Number of Clinic Visits	Number of clinic visits made by patients after surgery concerning wound morbidity per patient	Day of surgery to 30 days postoperative
Number of Participants With Morbid Outcomes After Delivery		Day of Surgery to 30 days postoperative
Number of Participants With Scheduled and Unscheduled Cesarean Section	Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity	Day of Surgery to 30 days postoperative
Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section	Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity	Day of Surgery to 30 days postoperative
Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section	Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes	Day of Surgery to 30 days postoperative
Number of Patients in Labor Versus no Labor Prior to Cesarean Section	Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor	Day of Surgery to 30 days postoperative
Number of Patients With Hypertension Versus no Hypertension	Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity	Day of Surgery to 30 days postoperative
Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes	Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.	Day of Surgery to 30 days postoperative
Number of Patients With Chorioamnionitis Versus no Chorioamnionitis	Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity	Day of Surgery to 30 days postoperative

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: 3M
• Investigators: Principal Investigator: Scott Roberts, MD, UT southwestern Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2015
• Primary Completion (Actual): August 30, 2016
• Study Completion (Actual): October 21, 2016

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: November 7, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: STU 042014-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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