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NCT Number: NCT04003038

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

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.

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Key information

Conditions

Body Mass Index Greater Than or Equal to 30 Body Weight Breast Diseases Breast Neoplasms Malignant Breast Neoplasm Mammoplasty Patient Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Edward I. Chang

CONTACT

713-794-1247

Edward I. Chang

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Negative Pressure Wound therapy

Procedure

Receive wound care with NPWT

Other names: NPWT, Vacuum-Assisted Wound Closure

wound care management

Procedure

Receive wound care with a standard dressing (bandage)

Other names: Wound Care, Wound Care Treatment, Wound Management, Wound Treatment

Primary outcomes

  1. Rate of wound dehiscence

    Time frame: Up 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.

  2. Wound healing complications

    Time frame: Up 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edward H Chang

CONTACT

[email protected]

713-794-1247

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jul 1, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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