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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 7 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of negative pressure wound therapy, which uses suction to help a wound heal, and how well it works compared with standard bandages. It is for people with obesity having breast reconstruction using tissue from their belly. The treatment is used on the belly cut where tissue was taken.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Having breast reconstruction using tissue taken from the belly in a surgery called an SIEA, DIEP, or muscle-sparing TRAM flap.
  • Willing and able to give consent to join the study.
  • Have a body mass index (BMI) of 30 or higher. BMI is a measure based on height and weight.

Who can't join

  • Unable to give consent to join the study.
  • Pregnant or thought to be pregnant.
  • Have a known allergy to adhesives used on the skin.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX