Your session is about to expire
← Back to Search
Negative Pressure Wound Therapy for Breast Reconstruction in Obese Patients
N/A
Recruiting
Led By Edward H Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Must not have
Patients who are unable to provide consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for obese patients with a BMI of 30 or higher who are undergoing free flap breast reconstruction surgery after breast cancer. They must be able to consent and not have allergies to topical adhesives. Pregnant individuals cannot participate.
What is being tested?
The study is testing if Negative Pressure Wound Therapy (NPWT) can better heal abdominal incisions compared to standard wound care in obese patients having tissue moved for breast reconstruction.
What are the potential side effects?
Possible side effects may include skin irritation, discomfort at the treatment site, or an allergic reaction to the NPWT materials used on the wound.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a specific type of breast reconstruction using tissue from my abdomen.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to give consent by myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of wound dehiscence
Wound healing complications
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (NPWT)Experimental Treatment1 Intervention
Patients receive NPWT after surgery for 7 days.
Group II: Group I (wound care with a standard dressing)Active Control1 Intervention
Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Negative Pressure Wound Therapy
2017
N/A
~4600
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,465 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,500 Total Patients Enrolled
Edward H ChangPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to give consent by myself.You have a BMI of 30 or higher.I am having a specific type of breast reconstruction using tissue from my abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (NPWT)
- Group 2: Group I (wound care with a standard dressing)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Breast Augmentation Patient Patient Testimony for trial: Trial Name: NCT04003038 — N/A