About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who are unable to provide consent.
Patients who are suspected or known to be pregnant.
Known allergy to topical adhesives.
Trial design
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy
Procedure/SurgeryReceive wound care with NPWT
Wound Care Management
Procedure/SurgeryReceive wound care with a standard dressing (bandage)
Treatment groups
Trial outcomes
Primary outcomes
Rate of wound dehiscence
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 complications
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.
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator