Negative Pressure Wound Therapy for Breast Reconstruction in Obese Patients

Overseen By Edward I. 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 tests a new method to aid wound healing after breast reconstruction surgery in individuals with a BMI of 30 or higher. It compares negative pressure wound therapy (NPWT), which uses a vacuum to promote healing, to regular bandages. The aim is to determine if NPWT can enhance healing of the abdominal incision where tissue was taken for the surgery. Suitable candidates for this trial include those undergoing breast reconstruction with tissue taken from the abdomen and who have a BMI of 30 or above. As an unphased trial, this study provides a unique opportunity to explore innovative healing methods for improved surgical outcomes.

Will I have to stop taking my current medications?

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

What prior data suggests that negative pressure wound therapy is safe for wound healing in obese patients undergoing breast reconstruction?

Research has shown that negative pressure wound therapy (NPWT) is generally safe and well-tolerated. Studies have found that using NPWT in breast surgery can lead to fewer wound-related problems. For example, one study found that NPWT after surgery reduced the chance of wounds reopening and might lower the risk of infections and other issues like fluid buildup under the skin. Another study showed that NPWT is more effective at preventing surgical site infections compared to regular bandages. Overall, these findings suggest that NPWT is a safe option for use in surgeries, with very few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Negative Pressure Wound Therapy (NPWT) for breast reconstruction in obese patients because it offers a unique method for managing post-surgical wounds. Unlike standard wound care, which typically involves regular bandage changes, NPWT uses a vacuum dressing to promote faster healing by increasing blood flow and reducing swelling. This method has the potential to lower the risk of complications, such as infections, which can be particularly challenging in obese patients. By maintaining a controlled environment for the wound, NPWT can also improve patient comfort and potentially lead to better overall outcomes.

What evidence suggests that negative pressure wound therapy is effective for healing abdominal incisions in obese patients?

This trial will compare Negative Pressure Wound Therapy (NPWT) with standard wound care in breast reconstruction for obese patients. Studies have shown that NPWT helps wounds heal better by using a vacuum to remove extra fluid and reduce swelling. Research indicates that NPWT can lower the risk of healing problems and improve the appearance of scars after abdominal surgeries. One study found that using NPWT instead of regular bandages led to better wound healing for patients undergoing similar surgeries. Early findings suggest that NPWT may be especially helpful for complex wound closures, such as those needed in breast reconstruction. Overall, NPWT shows promise in helping surgical wounds heal more effectively. ^{1 3 6 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, 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 (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 (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]

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]

Citations

1. withpower.com withpower.com/trial/negative-pressure-wound-therapy-for-breast-reconstruction-in-obese-patients-50cb4

Negative Pressure Wound Therapy for Breast ... This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273643/

Efficacy of Vacuum-assisted Wound Closure in Improving ... Negative-pressure wound therapy (NPWT) has been shown to facilitate complex wound closure, decrease healing complications, and improve scar ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1748681525004061

Efficacy of closed-incision negative pressure wound ... All randomized controlled trials and observational studies comparing closed-incision NPWT versus standard dressings in abdominal-based free flaps for breast ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943131/

A Preliminary Study on the Efficacy of NPWT Dressing This prospective exploratory study aimed to evaluate the efficacy of negative pressure wound therapy (NPWT) dressings in reducing postoperative ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06265558

Prevention of Postoperative Complications by Negative ... There is little scientific data concerning the use of negative pressure therapy after immediate breast reconstruction.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730037/

Prophylactic Use of Negative Pressure Wound Therapy in ... Our study suggests that prophylactic use of NPWT in oncoplastic and reconstructive breast surgery results in low rates of wound-related complications.

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2770848

Effect of Prophylactic Negative Pressure Wound Therapy ... This open-label randomized trial compares the effects of preventive negative pressure wound therapy vs standard wound dressing on surgical site infection.

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/22925503251336253

The Use of Negative Pressure Wound Therapy for Breast ... Our findings suggest NPWT following breast surgery reduces the risk of wound dehiscence, may have some effect on SSIs, hematoma, seroma, and skin/wound ...