Negative Pressure Wound Therapy for Breast Reduction Surgery

Recruiting at 1 trial location

Overseen By Ryan P Lin, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Must not be taking: Steroids, Immune modulators

Disqualifiers: Pregnancy, Smoking, Breast cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new method for wound care after breast reduction surgery. It compares closed incision negative pressure wound therapy (ciNPWT), a device that aids healing through gentle suction, with standard adhesive dressings. Researchers aim to determine if this new method can reduce complications, improve patient satisfaction, and prove cost-effective. Women scheduled for breast reduction surgery on both breasts, who meet specific surgical criteria and can attend follow-up visits, might be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve post-surgical care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use steroids or other immune modulators that affect wound healing.

What prior data suggests that this negative pressure wound therapy is safe for breast reduction surgery?

Research has shown that using a special type of bandage called prophylactic closed incision negative pressure wound therapy (ciNPWT) after surgery might be safe. Studies have found that patients using ciNPWT experienced fewer wound problems, such as infections and slow healing, compared to those with regular bandages.

One study found that ciNPWT reduced the risk of infections at the surgery site, helping wounds stay clean and heal faster. Reports of serious side effects were absent, suggesting that ciNPWT is generally well-tolerated.

Overall, current evidence supports the safety of ciNPWT, making it a potentially safe choice for those considering this treatment after breast reduction surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about prophylactic closed incision negative pressure wound therapy (ciNPWT) for breast reduction surgery because it offers a novel approach to promoting wound healing and preventing complications. Unlike standard adhesive dressings, ciNPWT uses a vacuum-sealed dressing to actively remove excess fluid and reduce swelling, which can accelerate healing and potentially lower the risk of infection. This method not only enhances the healing environment but may also improve scar quality, offering a significant advantage over traditional treatments.

What evidence suggests that prophylactic ciNPWT is effective for breast reduction surgery?

Research has shown that using a special bandage called prophylactic closed incision negative pressure wound therapy (ciNPWT) can improve recovery after surgery. In this trial, participants will receive ciNPWT on one breast following reduction mammaplasty, while the other breast will receive a standard adhesive dressing for comparison. Studies have found that ciNPWT lowers the risk of complications like infections and wound separation compared to regular bandages. Specifically, one study found that patients using ciNPWT experienced fewer wound issues and infections. Another study observed better healing and fewer instances of wound breakdown. These results suggest that ciNPWT could effectively reduce complications after surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Kenneth L Fan, MD

Principal Investigator

MedStar Georgetown University Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are planning to have breast reduction surgery using a specific technique at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital. Participants must be able to follow the study's procedures and attend all follow-up visits.

Inclusion Criteria

Able to comply with study procedures and follow-up visits

I am a female.

I am scheduled for a specific breast reduction surgery at MedStar Georgetown University Hospital or MedStar Good Samaritan Hospital.

Exclusion Criteria

I am biologically male.

Currently pregnant or lactating

I am a smoker who hasn't stopped smoking for at least 4 weeks before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reduction mammaplasty with either prophylactic closed incision negative pressure wound therapy or standard adhesive dressing

1 week

Immediate postoperative period, 1 week postoperatively

Follow-up

Participants are monitored for safety and effectiveness, including assessments of pain, scar quality, and patient satisfaction

6 months

1 month, 3 months, and 6 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic ciNPWT
• Standard Adhesive Dressing

Trial Overview The study compares two types of dressings after breast reduction surgery: a new method called closed incision negative pressure wound therapy (ciNPWT) and the standard adhesive dressing, focusing on complications, patient satisfaction, and cost differences.

How Is the Trial Designed?

Group I: Prophylactic ciNPWT Experimental Treatment 1 Intervention

Participants in this arm will receive the prophylactic closed incision negative pressure wound therapy (ciNPWT) on one breast following reduction mammaplasty. The ciNPWT will be applied for up to 7 days postoperatively to promote wound healing and prevent complications.

Group II: Standard Adhesive Dressing Active Control 1 Intervention

Participants in this arm will receive the standard adhesive strip dressing (Prineo Ethicon NJ) on the other breast following reduction mammaplasty. The standard dressing will be used as a control to compare postoperative outcomes against the ciNPWT.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Published Research Related to This Trial

In a study of 32 patients undergoing breast reduction surgery, negative pressure wound therapy (NPWT) significantly reduced wound healing complications compared to traditional fixation strips, with a p-value of less than 0.004.

Patients treated with NPWT reported better aesthetic outcomes and quality of scarring at 42 and 90 days, indicating that NPWT is a promising option for improving surgical recovery and scar appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality. Tanaydin, V., Beugels, J., Andriessen, A., et al.[2019]

Closed-incision negative pressure wound therapy (ciNPWT) significantly reduces the rate of wound dehiscence in abdominal donor sites during microsurgical breast reconstruction, with an odds ratio of 0.53 based on a meta-analysis of 1009 patients across eight studies.

While ciNPWT does not significantly lower the rates of total wound complications, infections, or seromas, its ability to offload tension from wound edges appears beneficial for preventing wound dehiscence compared to conventional dressings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Closed-incision Negative Pressure Wound Therapy on Abdominal Site Complications in Autologous Breast Reconstruction. Dunson, B., Kogan, S., Grosser, JA., et al.[2023]

In a study of 79 patients undergoing breast reduction, the use of closed incisional negative pressure therapy (ciNPT) significantly reduced early wound dehiscence to only 2% compared to 14% in patients using standard dressings, indicating a strong efficacy in preventing complications.

The results suggest that ciNPT not only lowers the risk of early dehiscence but also eliminates the need for debridement in patients, showcasing its potential as a safer alternative in postoperative care for breast reduction surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incisional Negative Pressure Therapy Significantly Reduces Early Wound Dehiscence after Reduction Mammaplasty. Johnson, ON., Reitz, CL., Thai, K.[2022]

In a study of 37 patients undergoing oncological breast surgery, the use of closed incision negative pressure therapy (ciNPT) resulted in only 4% of surgeries experiencing complications, compared to 45% in the standard care group, highlighting its efficacy in reducing postsurgical complications.

Patients using ciNPT reported significantly better outcomes in terms of scar quality and overall satisfaction, suggesting that ciNPT is a reliable and adaptable dressing option for patients with multiple risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings. Ferrando, PM., Ala, A., Bussone, R., et al.[2022]

In a multicenter trial involving 200 patients undergoing bilateral reduction mammaplasty, negative pressure wound therapy (NPWT) significantly reduced overall healing complications compared to standard wound care, with a 5% lower incidence of complications in NPWT-treated breasts.

NPWT also led to a 38% reduction in the incidence of dehiscence (wound reopening) by day 21, demonstrating its efficacy in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional Negative Pressure Wound Therapy for Prevention of Wound Healing Complications Following Reduction Mammaplasty. Galiano, RD., Hudson, D., Shin, J., et al.[2022]

Closed incision negative pressure therapy (ciNPT) significantly reduces the rate of clinically relevant postoperative complications, such as wound dehiscence, in patients undergoing oncoplastic breast surgery, with complication rates of 5.3% compared to 16.9% in those without ciNPT.

Despite the ciNPT group having higher baseline risk factors like BMI and ASA levels, the therapy still led to fewer complications, suggesting it is a beneficial intervention for patients at increased risk for postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncoplastic Breast Surgery: A Comparison of Outcomes. Wareham, CM., Karamchandani, MM., Ku, GC., et al.[2023]

A systematic review of seven studies involving 1500 breast incisions in 904 patients found that negative pressure wound therapy (NPWT) significantly reduces the rate of total wound complications, including surgical site infections (SSI), seromas, wound dehiscence, and necrosis compared to standard dressings.

NPWT was associated with a lower odds ratio for various complications, indicating its efficacy in improving wound healing in closed surgical incisions, although no significant difference was found in the rate of hematomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Prophylactic Negative Pressure Wound Therapy for Closed Incisions in Breast Surgery: A Systematic Review and Meta-Analysis. Cagney, D., Simmons, L., O'Leary, DP., et al.[2021]

In a study of 150 patients undergoing oncoplastic breast surgery, the use of closed incision negative pressure therapy (ciNPT) significantly reduced postoperative wound healing complications, with a complication rate of 10.3% compared to 31% in the standard of care group.

Patients treated with ciNPT experienced no delays in starting adjuvant therapy, while 22.5% of those receiving standard care faced delays, highlighting ciNPT's potential to improve recovery and treatment timelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncoplastic Surgery Prevents Delays to Adjuvant Therapy. Ockerman, KM., Bryan, J., Wiesemann, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5811280/

Incisional Negative Pressure Wound Therapy for Prevention of ... It has been proposed that negative pressure wound therapy (NPWT) applied prophylactically to a closed incision may decrease the incidence of wound complications ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06725459

NCT06725459 | NPWT Reduction Mammaplasty Participants in this arm will receive the prophylactic closed incision negative pressure wound therapy (ciNPWT) on one breast following reduction mammaplasty.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1479666X25000228

Closed incision negative pressure wound therapy in ... Its use has been shown to have favourable wound outcomes including reduced SSI, dehiscence and necrosis rates compared to standard dressings; however, the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9885480/

Effectiveness of prophylactic application of negative ... The prophylactic application of negative pressure wound therapy women had a significantly lower total wound problems, surgical site wound infection, wound ...

5. academic.oup.com academic.oup.com/asjopenforum/article/doi/10.1093/asjof/ojae073/7747223

Efficacy of Closed-Incision Negative Pressure Wound Therapy ... Our study suggests that the use of ciNPWT in implant-based breast reconstruction postradiotherapy can potentially reduce postoperative complications.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1015958424017068

The use of incisional negative-pressure wound therapy on ... This study aim to compare recovery times and wound site complications between patients treated with conventional wound dressings and patients treated with iNPWT ...

7. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00282-1/fulltext

Incisional negative pressure wound therapy for the ... Some research suggests that negative pressure wound therapy (iNPWT) on primary closed incisional wounds effectively reduces the risk of surgical ...