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

Status: Active

Description

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.

Eligibility Criteria

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.

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Edward I Chang
Phone: 713-794-1247

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
M D Anderson Cancer Center

Principal Investigator
Edward H. Chang

Trial IDs

Primary ID 2018-0004
Secondary IDs NCI-2019-02777
Clinicaltrials.gov ID NCT04003038