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

(VAC Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed by surgery. These wounds have a very high rate of wound complications and infection (30%), resulting in more surgeries, longer hospital stays and complex nursing care. Previous research shows that negative pressure (vacuum) dressings applied to the incision at the end of surgery can reduce these complications. The Investigator and his team across Canada will perform a clinical trial comparing standard dressings to these vacuum dressings. The results of this study have the potential to immediately improve the quality of life of soft tissue cancer patients. It can also decrease the amount of time required in hospital and reduce the cost to the Canadian healthcare system.

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 data supports the effectiveness of the treatment Incisional Negative Pressure Wound Therapy (INPWT) for post-surgical wounds in soft tissue sarcoma?

Research shows that Incisional Negative Pressure Wound Therapy (iNPWT) is beneficial in promoting wound healing and reducing complications like infections and dehiscence (wound reopening) in high-risk surgical wounds. It has been effectively used in various surgical fields, suggesting potential benefits for post-surgical wounds in soft tissue sarcoma as well. ^{1 2 3 4 5}

Is negative pressure wound therapy safe for humans?

Negative pressure wound therapy (NPWT) is generally considered safe and is widely used in various surgical fields to help wounds heal and reduce complications like infections and wound reopening. However, some studies mention potential issues like skin blistering or seroma (fluid buildup) that may need attention. ^{1 2 3 4 5}

How does the treatment Incisional Negative Pressure Wound Therapy (INPWT) differ from other treatments for post-surgical wounds in soft tissue sarcoma?

Incisional Negative Pressure Wound Therapy (INPWT) is unique because it uses a vacuum system to promote healing by reducing tension on the wound and removing excess fluid, which can help prevent complications like infections and wound reopening. This approach is different from traditional dressings that do not actively manage wound tension or fluid evacuation. ^{1 2 3 4 5}

Research Team

Joel Werier

Principal Investigator

Surgeon

Eligibility Criteria

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 am 18 or older and can sign a consent form.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Prophylactic negative pressure wound therapy after open ventral hernia repair: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Within-patient randomized clinical trial comparing incisional negative-pressure wound therapy with suction drains in gender-affirming mastectomies. [2023]

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

Biomechanical Effects of Incisional Negative Wound Pressure Dressing: An Ex Vivo Model Using Human and Porcine Abdominal Walls. [2022]

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

Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. [2021]

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

Modified Incisional Negative Pressure Wound Therapy Increases Seroma Evacuation: An Ex Vivo Model. [2022]