Recruiting

Negative Pressure

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04003038

Conditions

Body Mass Index Greater Than or Equal to 30

Malignant Breast Neoplasm

Mammoplasty Patient

Obesity

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Negative Pressure Wound Therapy

Wound Care Management

Study Details

Brief summary:

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.

Conditions

Body Mass Index Greater Than or Equal to 30

Malignant Breast Neoplasm

Mammoplasty Patient

Obesity

Study ID

NCT04003038

Start date

May 2, 2019

Status verified date

Apr, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group I (wound care with a standard dressing)

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

experimental: Group II (NPWT)

Patients receive NPWT after surgery for 7 days.

Interventions

Negative Pressure Wound Therapy

Receive wound care with NPWT

Wound Care Management

Receive wound care with a standard dressing (bandage)

Primary outcome measure

  • Rate of wound dehiscence [ Time Frame: Up to 3 months ]
  • Wound healing complications [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Edward H Chang

713-794-1247eichang@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Edward I. Chang

713-794-1247

Principal Investigator:

Edward I. Chang

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-21.