TrialGlobe

Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT04003038

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionBody Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity

Full registry 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.

Treatments and study arms

Negative Pressure Wound Therapy

Procedure

Receive wound care with NPWT

Wound Care Management

Procedure

Receive wound care with a standard dressing (bandage)

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

M D Anderson Cancer Center🇺🇸 Houston, Texas, United States
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Edward I. ChangContact
Call 713-794-1247
Edward I. ChangPrincipal Investigator