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Wound Dressing

Negative Pressure Wound Therapy for Post-Surgical Wounds in Soft Tissue Sarcoma (VAC Trial)

N/A

Recruiting

Led By Joel Werier

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients for which a primary closure must be attained at the time of surgery

Patients with lower extremity soft tissue sarcoma confirmed by tissue pathology. Each patient must have local cross sectional imaging (CT or MRI) and a staging CT chest

Must not have

Patients who are less than 18 years of age

Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare standard dressings to negative pressure (vacuum) dressings applied to the incision at the end of surgery in order to reduce wound complications and infection rates.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for INPWT versus standard wound dressing in this summary, negative pressure therapy may sometimes cause skin irritation or discomfort at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery requires the wound to be fully closed.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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My surgical wound was not closed with simple stitches.

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I have had a surgical amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Wound Complication including re-operation for superficial or deep site infection

Secondary study objectives

Functional outcome

Overall cost

patient satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VAC Wound DressingExperimental Treatment1 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 DressingActive Control1 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.

0 / 5Eligibility criteria met