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Recruiting Not applicable NCT04003038

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

No applicable phase (e.g. observational)
Conditions: Body Mass Index Greater Than or Equal to 30 Malignant Breast Neoplasm Mammoplasty Patient Obesity

Sponsor: M.D. Anderson Cancer Center

trial.available_in: БГ
Overview
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.
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.
Who can participate
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.
Interventions
Negative Pressure Wound Therapy
PROCEDURE
Wound Care Management
PROCEDURE
Locations 1
United States (1)
M D Anderson Cancer Center
Houston , Texas
Edward I. Chang
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
02.05.2019
Completion date
30.04.2028
Registry ID
NCT04003038
Source
clinicaltrials.gov
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