Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURENegative Pressure Wound Therapy
Receive wound care with NPWT
PROCEDUREWound Care Management
Receive wound care with a standard dressing (bandage)
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound dehiscence | 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. |
| Wound healing complications | 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. |
Countries
United States
Contacts
CONTACTEdward H Chang
PRINCIPAL_INVESTIGATOREdward H Chang
M.D. Anderson Cancer Center
Outcome results
None listed