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Negative Pressure Wound Therapy for Abdominal Incisions in Obese Breast Reconstruction Patients

This study is looking at whether negative pressure wound therapy (NPWT) helps heal abdominal incisions better than standard bandages in obese women having breast reconstruction surgery. You might be able to join if you are an obese woman (BMI 30 or higher) having breast reconstruction using tissue from your abdomen (free abdominal flap). The researchers want to see if NPWT can reduce problems like wounds opening up (dehiscence) or other healing complications within three months after surgery. The current status of this study is unclear, and it plans to enroll 80 participants.

Study design
This study is interventional and plans to enroll 80 women. Participants will be randomly assigned to receive either negative pressure wound therapy or a standard bandage after surgery.
What's involved
You would receive either negative pressure wound therapy or a standard dressing for 7 days after surgery. You would then have follow-up visits at 2 weeks, 1 month, and 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed up at 2 weeks, and at 1 and 3 months after the study treatment.

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NCT04003038

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

Recruiting
NAAges 18+InterventionalPrevention
M.D. Anderson Cancer Center
~80 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:Negative Pressure Wound TherapyWound Care Management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of wound dehiscence
Measured over Up to 3 months
+1 more outcome measured

Conditions

Body Mass Index Greater Than or Equal to 30
Malignant Breast Neoplasm
Mammoplasty Patient
Obesity

Explore related trials

Breast CarcinomaObesity

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Edward H Chang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Edward H Chang
[email protected]
713-794-1247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of wound dehiscenceUp to 3 months

    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.

  • Wound healing complicationsUp to 3 months

    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.