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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 days

Awards & highlights

VAC Trial 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.Check my eligibility

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.See study design

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.

VAC Trial 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.

VAC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Functional outcome

Overall cost

patient satisfaction

VAC 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,400 Total Patients Enrolled

Dr. J. WerierLead Sponsor

Joel WerierPrincipal InvestigatorSurgeon

Media Library

Incisional Negative Pressure Wound Therapy (INPWT) (Wound Dressing) Clinical Trial Eligibility Overview. Trial Name: NCT03175718 — N/A

Soft Tissue Sarcoma Research Study Groups: VAC Wound Dressing, Control Wound Dressing

Soft Tissue Sarcoma Clinical Trial 2023: Incisional Negative Pressure Wound Therapy (INPWT) Highlights & Side Effects. Trial Name: NCT03175718 — N/A

Incisional Negative Pressure Wound Therapy (INPWT) (Wound Dressing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03175718 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to participate in this trial at this time?

"Affirmative. The information available on clinicaltrials.gov shows that this experiment is currently in the patient recruitment phase; it was posted on February 1st 2022, with its most recent update occurring on February 10th 2022. A total of 291 patients are desired from two different sites for the trial to be successful."

Answered by AI

How many participants are eligible for inclusion in this investigation?

"Verified. Per clinicaltrials.gov, this research project is still recruiting patients as of February 10th 2022 and was initially posted on the first day of February 2021. To date, 291 participants are needed for this trial at 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients

Dr. J. Werier 2022. "INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03175718.

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