Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative Pressure Wound Therapy, Wound Care Management.
- Who it may be relevant to
- Registry conditions: Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
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.
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
- Procedure Negative Pressure Wound Therapy
Receive wound care with NPWT - Procedure Wound Care Management
Receive wound care with a standard dressing (bandage)
Primary outcome measures
- Rate of wound dehiscence [Time frame: Up to 3 months]
- Wound healing complications [Time frame: Up to 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT04003038 · 2018-0004 · NCI-2019-02777 · 2018-0004 · P30CA016672