Negative Pressure Wound Therapy for Breast Reconstruction in Obese Patients

Overseen By Edward H Chang

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Allergy to adhesives, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

80 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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. ^{1 3 4 7 8}

Who Is on the Research Team?

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?

Group I: Group II (NPWT) Experimental Treatment 1 Intervention

Patients receive NPWT after surgery for 7 days.

Group II: Group I (wound care with a standard dressing) Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure in the treatment of gynecologic oncology wound failures. Schimp, VL., Worley, C., Brunello, S., et al.[2004]

Negative pressure wound therapy (NPWT), also known as topical negative pressure or VAC, is a technique that promotes healing in various types of wounds by applying negative pressure.

Over the past 50 years, NPWT has been shown to effectively enhance wound healing, leading to the development of multiple devices that provide healthcare professionals with more options for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of negative pressure wound therapy (NPWT). Thompson, G.[2008]

Negative-pressure wound therapy, or vacuum-assisted closure (VAC) therapy, has been shown to enhance wound healing by increasing blood flow and granulation tissue formation while reducing fluid and bacteria accumulation.

This report highlights the successful application of VAC therapy on a large infected facial wound, demonstrating its potential effectiveness in challenging wound locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of vacuum-assisted closure therapy for the treatment of a large infected facial wound. Schuster, R., Moradzadeh, A., Waxman, K.[2006]

Topical negative pressure therapy (TNP) has been effectively used in wound management since the late 1990s, particularly for chronic nonhealing wounds.

Recent studies suggest that TNP not only aids in healing but also plays a beneficial role in preparing the wound bed for further treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical negative pressure therapy. Collier, M.[2017]

Negative pressure wound therapy, known as Vacuum Assisted Closure (VAC) therapy, is essential in plastic surgery for promoting wound healing.

The abstract highlights the benefits of VAC therapy, although it also raises concerns about the associated costs of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum assisted closure therapy: a must in plastic surgery. Paul, JC.[2022]

Negative pressure wound therapy (NPWT) effectively treated a giant hepatic abscess in a 28-year-old male after a gunshot wound, leading to significant reduction in abscess size and cessation of bile leakage over 15 days.

NPWT, especially with instillation therapy, can be beneficial even in the presence of infection, highlighting its potential as an adjunctive treatment for complex wounds like abscesses, although its use in such cases is still not fully established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. Abidali, M., Bauer, F., Gottlieb, M., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

An economic evaluation of the use of TNP on full-thickness wounds. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Is negative-pressure wound therapy beneficial in modern-day breast surgery? [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure in the treatment of gynecologic oncology wound failures. [2004]

4. England pubmed.ncbi.nlm.nih.gov

An overview of negative pressure wound therapy (NPWT). [2008]

5. United States pubmed.ncbi.nlm.nih.gov

The use of vacuum-assisted closure therapy for the treatment of a large infected facial wound. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Topical negative pressure therapy. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Vacuum assisted closure therapy: a must in plastic surgery. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy with intermittent irrigation for treatment of post-traumatic giant abscess: A case report. [2022]