80 Participants Needed

Negative Pressure Wound Therapy for Breast Reconstruction in Obese Patients

EH
Overseen ByEdward H Chang
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is negative pressure wound therapy (NPWT) safe for humans?

Negative pressure wound therapy (NPWT), also known as vacuum-assisted closure (VAC) or topical negative pressure (TNP) therapy, has been used safely in humans for over 50 years to promote healing in various types of wounds, including infected and chronic wounds. It has been shown to increase blood flow and reduce bacteria in wounds, which supports its safety profile.12345

How does negative pressure wound therapy differ from other treatments for breast reconstruction in obese patients?

Negative pressure wound therapy (NPWT) is unique because it uses a vacuum to apply negative pressure to the wound, which helps increase blood flow, reduce fluid buildup, and promote faster healing. This method can decrease complications and improve scar quality compared to standard treatments, especially in breast reconstruction surgeries.13467

What data supports the effectiveness of the treatment Negative Pressure Wound Therapy for breast reconstruction in obese patients?

Existing data suggests that Negative Pressure Wound Therapy (NPWT) can reduce complications and improve healing in breast surgery, such as decreasing seroma formation and overall complications after expander-based breast reconstruction. However, more large studies are needed to confirm its effectiveness specifically in breast surgery.13478

Who Is on the Research Team?

EH

Edward I. Chang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have a BMI of 30 or higher.
I am having a specific type of breast reconstruction using tissue from my abdomen.
Patients are willing and able to give consent.

Exclusion Criteria

I am unable to give consent by myself.
Patients who are suspected or known to be pregnant.
Known allergy to topical adhesives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either standard dressing or negative pressure wound therapy (NPWT) after surgery for 7 days

1 week
1 visit (in-person)

Follow-up

Participants are monitored for wound healing complications and adverse events

3 months
3 visits (in-person) at 2 weeks, 1 month, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Negative Pressure Wound Therapy
  • Wound Care Management
Trial Overview 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.
How Is the Trial Designed?
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.

Negative Pressure Wound Therapy is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸
Approved in United States as Negative Pressure Wound Therapy for:
  • Acute wounds
  • Chronic wounds
  • Diabetic foot ulcers
  • Skin grafts
  • Surgical incisions
  • Burns
🇪🇺
Approved in European Union as Negative Pressure Wound Therapy for:
  • Acute wounds
  • Chronic wounds
  • Diabetic foot ulcers
  • Skin grafts
  • Surgical incisions
  • Burns
🇨🇦
Approved in Canada as Negative Pressure Wound Therapy for:
  • Acute wounds
  • Chronic wounds
  • Diabetic foot ulcers
  • Skin grafts
  • Surgical incisions
  • Burns
🇨🇭
Approved in Switzerland as Negative Pressure Wound Therapy for:
  • Acute wounds
  • Chronic wounds
  • Diabetic foot ulcers
  • Skin grafts
  • Surgical incisions
  • Burns

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study involving 54 patients with full-thickness wounds, topical negative pressure (TNP) therapy showed significantly higher material costs compared to conventional moist gauze treatment, but it resulted in lower nursing expenses and shorter hospital stays.
Despite the higher material costs associated with TNP, the overall costs per patient were similar to those of conventional therapy due to reduced dressing changes and quicker readiness for surgical closure.
An economic evaluation of the use of TNP on full-thickness wounds.Mouës, CM., van den Bemd, GJ., Meerding, WJ., et al.[2022]
Negative-pressure wound therapy (NPWT) has shown promising results in reducing complications and improving healing in breast surgery, particularly after expander-based breast reconstruction, with healing durations ranging from 7 to 21 days.
A randomized study involving 200 participants indicated that NPWT significantly decreased overall complications and protected against wound dehiscence in closed incisional wounds after reduction mammoplasty, highlighting its potential benefits in surgical recovery.
Is negative-pressure wound therapy beneficial in modern-day breast surgery?Matusiak, D., Wichtowski, M., Pieszko, K., et al.[2023]
In a study of 27 gynecologic oncology patients, the use of a vacuum-assisted closure (VAC) device led to a remarkable 96% reduction in wound size, demonstrating its efficacy in treating complex wound failures.
The VAC therapy was found to be safe, with only one patient experiencing bleeding and 26 patients having no complications; 96% of patients achieved complete wound healing by the end of the follow-up period.
Vacuum-assisted closure in the treatment of gynecologic oncology wound failures.Schimp, VL., Worley, C., Brunello, S., et al.[2004]

Citations

An economic evaluation of the use of TNP on full-thickness wounds. [2022]
Is negative-pressure wound therapy beneficial in modern-day breast surgery? [2023]
Vacuum-assisted closure in the treatment of gynecologic oncology wound failures. [2004]
An overview of negative pressure wound therapy (NPWT). [2008]
The use of vacuum-assisted closure therapy for the treatment of a large infected facial wound. [2006]
Topical negative pressure therapy. [2017]
Vacuum assisted closure therapy: a must in plastic surgery. [2022]
Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security