Negative Pressure Wound Therapy for Post-Surgical Wounds in Soft Tissue Sarcoma

(VAC Trial)

Recruiting at 2 trial locations

Overseen By Yusra K Al-Mosuli

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Benign disease, Prior radiation, Amputation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

291 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if vacuum dressings (special bandages that use suction) on post-surgery wounds can reduce complications and infections in patients with soft tissue sarcoma, an aggressive cancer. Researchers will compare these vacuum dressings, known as Incisional Negative Pressure Wound Therapy (INPWT), to regular bandages to identify which is more effective. The goal is to improve recovery, shorten hospital stays, and lower healthcare costs. The trial seeks patients who have undergone radiation and surgery for lower limb soft tissue sarcoma and can have their wound closed during surgery. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance post-surgical care.

Do I need to stop my current medications for this trial?

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 post-surgical wounds in soft tissue sarcoma patients?

Research has shown that Incisional Negative Pressure Wound Therapy (INPWT) is generally safe and aids healing after surgeries. Studies have found that this vacuum therapy on surgical wounds reduces the risk of complications like infections. For example, one study found that applying negative pressure to wounds after surgery for soft tissue sarcoma lowered the chance of infections and other wound issues.

Further research suggests that this therapy is not only effective but also well-tolerated by patients. It speeds up healing and reduces the need for additional surgeries. So far, no major safety concerns have been reported when using this therapy after surgeries for soft tissue cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for post-surgical wounds in soft tissue sarcoma, which usually involves standard gauze dressings, Incisional Negative Pressure Wound Therapy (INPWT) uses a vacuum-assisted method to promote healing. Researchers are excited about INPWT because it actively removes excess fluids and reduces swelling around the wound, speeding up the healing process. This technique may also lower the risk of infection and improve overall wound closure outcomes, offering potential benefits over traditional wound care methods.

What evidence suggests that Incisional Negative Pressure Wound Therapy is effective for post-surgical wounds in soft tissue sarcoma?

Research has shown that Incisional Negative Pressure Wound Therapy (INPWT), which participants in this trial may receive, can help reduce wound problems in patients with soft tissue sarcomas. One study found that using this therapy after surgery lowered the risk of wound infections and other complications. Another study showed that patients who received INPWT experienced better wound healing compared to those with regular dressings. This therapy works by applying a gentle vacuum to the wound, keeping it clean and speeding up healing. These findings suggest that INPWT can be a useful tool for improving recovery after cancer-related surgeries. In this trial, some participants will receive the VAC Wound Dressing, while others will receive a Control Wound Dressing with standard gauze and no negative pressure application. ^{1 2 3 4 6}

Who Is on the Research Team?

Joel Werier

Principal Investigator

Surgeon

Are You a Good Fit for This Trial?

Adults with lower extremity soft tissue sarcoma confirmed by pathology, who will receive preop radiation followed by limb-saving surgery. They must be able to consent and attend follow-ups. Excluded are those under 18, with benign diseases, prior radiation in the area not linked to current treatment, amputations, non-primary closures like grafts or flaps, life expectancy under 120 days, or allergies to adhesive dressings.

Inclusion Criteria

My surgery requires the wound to be fully closed.

I have a confirmed soft tissue sarcoma in my leg and have had the required scans.

Patient must be available for postoperative follow-up at the treating center

Exclusion Criteria

I have had radiation in the past, not related to my current treatment.

Patients with a life expectancy less than 120 days

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive preoperative radiation therapy

4-6 weeks

Surgery and Dressing Application

Limb salvage surgery is performed, followed by application of either vacuum dressing or standard dressing for 7 days

1 week

Follow-up

Participants are monitored for wound complications, length of hospital stay, patient quality of life, satisfaction, and function

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Incisional Negative Pressure Wound Therapy (INPWT)
• VAC Wound Dressing
• Wound Dressing

Trial Overview The trial is testing if vacuum dressings (INPWT) on surgical incisions can reduce wound complications compared to standard dressings in patients having surgery after radiation for aggressive soft tissue cancers of the lower limbs.

How Is the Trial Designed?

Group I: VAC Wound Dressing Experimental Treatment 1 Intervention

Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 7 days of Incisional Negative pressure wound therapy.

Group II: Control Wound Dressing Active Control 1 Intervention

Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive standard gauze dressing with no negative pressure application.

Incisional Negative Pressure Wound Therapy (INPWT) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Negative Pressure Wound Therapy for:

• Wound complications following surgery
• Chronic wounds
• Diabetic foot ulcers
• Venous leg ulcers

Approved in Canada as Incisional Negative Pressure Wound Therapy for:

• Prevention of wound complications after lower extremity sarcoma surgery with preoperative radiation therapy

Approved in European Union as Vacuum-Assisted Closure for:

• Wound complications following surgery
• Chronic wounds
• Diabetic foot ulcers
• Venous leg ulcers

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Dr. J. Werier

Lead Sponsor

Trials

1

Recruited

290+

Published Research Related to This Trial

The study established ex vivo models of incisional negative pressure wound therapy (iNPWT) in porcine and human abdominal wall tissues, demonstrating that the pressure within the wound does not increase proportionally to the applied negative pressure, which raises questions about the effectiveness of iNPWT in wound care.

iNPWT was only able to evacuate about 75% of seroma volume, indicating that while it may have some benefits, its efficacy in managing wound healing and seroma evacuation is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical Effects of Incisional Negative Wound Pressure Dressing: An Ex Vivo Model Using Human and Porcine Abdominal Walls. Jansen-Winkeln, B., Niebisch, S., Scheuermann, U., et al.[2022]

In a study involving 85 transgender men undergoing gender-affirming mastectomies, using incisional negative-pressure wound therapy (iNPWT) instead of standard dressing and suction drains did not reduce overall wound healing complications, but it did lead to a significant increase in seroma rates.

Patients reported significantly less pain and greater comfort with iNPWT compared to standard treatment, indicating a potential benefit in terms of patient experience despite the increased risk of seromas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies. Timmermans, FW., Mokken, SE., Smit, JM., et al.[2023]

In a study using porcine models, modifications to the incisional negative wound pressure therapy (iNPWT) dressing, such as adding a suction drain tube, significantly improved seroma evacuation and increased intrawound pressure, enhancing the dressing's effectiveness.

The results suggest that these technical modifications can help reduce the risk of postoperative wound infections and complications by ensuring better drainage of seromas, which are pockets of fluid that can lead to infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Incisional Negative Pressure Wound Therapy Increases Seroma Evacuation: An Ex Vivo Model. Mehdorn, M., Jansen-Winkeln, B.[2022]

Negative pressure wound therapy on closed incisions (iNPWT) significantly reduces the risk of surgical site occurrences (SSO) and surgical site infections (SSI) in patients undergoing open ventral hernia repair, based on a meta-analysis of 10 studies involving 1087 patients.

There was no significant difference in the risk of hernia recurrence between iNPWT and conventional wound dressing, suggesting that while iNPWT improves healing and reduces complications, it does not affect the likelihood of hernia returning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic negative pressure wound therapy after open ventral hernia repair: a systematic review and meta-analysis. Berner-Hansen, V., Oma, E., Willaume, M., et al.[2022]

A systematic review of 10 studies involving 626 surgical incisions found that incisional negative pressure wound therapy (INPWT) significantly reduces the incidence of infections compared to standard sterile dry dressings.

While there are some indications that INPWT may reduce dehiscence rates, the evidence is inconsistent, and there is insufficient data to draw conclusions about its effects on seroma, hematoma, or skin necrosis, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Ingargiola, MJ., Daniali, LN., Lee, ES.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12464026/

Impact of vacuum assisted wound therapy on ... Based on the results, the use of NWPT can be essential for wound management in sarcomas and improve convalescence and oncological treatment.

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02638298?tab=table

Incisional Negative Pressure Wound Therapy for ... There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these ...

4. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/11/PAGE/502/FULLTEXT/

Negative Pressure Wound Therapy for Closed Surgical ... The aim of this study was to evaluate the wound healing outcomes in patients with high risk wounds after sarcoma resection treated with and without use of NPWT.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X23000077

What is the influence of negative pressure wound therapy ... A retrospective study reported that NPWT following excision of lower extremity soft-tissue sarcoma resection is associated with a lower risk of wound ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6437357/

Does Vacuum-assisted Closure Reduce the Risk of Wound ... Incisional vac-assisted closure has been shown to decrease postoperative wound complications in both nononcologic and oncologic settings [4, 5, 15, 17, 19], but ...