Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery

A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients

This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Malignant Breast Neoplasm; Body Mass Index Greater Than or Equal to 30; Mammoplasty Patient
• Intervention / Treatment: Procedure: Wound Care Management; Procedure: Negative Pressure Wound Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate.

II. Long-term follow-up on wound healing complications.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.

GROUP II: Patients receive negative pressure wound therapy (NPWT) after surgery for 7 days.

After completion of study, patients are followed up at 2 weeks, and at 1 and 3 months.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward H Chang; Phone Number: 713-794-1247; Email: eichang@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Edward I. Chang; Phone Number: 713-794-1247
      • Principal Investigator: Edward I. Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
• Patients are willing and able to give consent.
• Body mass index (BMI) greater than or equal to 30.0.

Exclusion Criteria:

• Patients who are unable to provide consent.
• Patients who are suspected or known to be pregnant.
• Known allergy to topical adhesives.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (wound care with a standard dressing); Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.	Procedure: Wound Care Management; Receive wound care with a standard dressing (bandage); Other Names: Wound Care; Wound Care Treatment; Wound Management; Wound Treatment
Experimental: Group II (NPWT); Patients receive NPWT after surgery for 7 days.	Procedure: Negative Pressure Wound Therapy; Receive wound care with NPWT; Other Names: NPWT; Vacuum-Assisted Wound Closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of wound dehiscence	Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.	Up to 3 months
Wound healing complications	Will measure and compare the wound healing outcomes of patients. All adverse events will be identified, graded for severity and assigned causality, reported to the required entities, and compiled for periodic review. After assigning causality, the principal investigator will decide the course of action for the study participant.	Up to 3 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Edward H Chang, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2018-0004 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2019-02777 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No