Recruiting

INPWT

Sponsor:

Dr. J. Werier

Code:

NCT03175718

Conditions

Soft-tissue Sarcoma

Wound Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Incisional Negative Pressure Wound Therapy (INPWT)

Wound Dressing

Study Details

Brief summary:

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.

Conditions

Soft-tissue Sarcoma

Wound Complication

Study ID

NCT03175718

Start date

Feb 1, 2022

Status verified date

Feb, 2026

Completion date

Jan 28, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients 18 years of age and older and are able to provide written consent.
  • 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.
  • Patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery.
  • Patients for which a primary closure must be attained at the time of surgery.
  • Patient must be available for postoperative follow-up at the treating center.

Exclusion Criteria:

  • Patients who are less than 18 years of age.
  • Patients with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans).
  • Patients who underwent surgical amputation
  • Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts).
  • Patients with a life expectancy less than 120 days.
  • Patients who have an allergy or sensitivity to adhesive dressings.

Study Design

Enrollment

291 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VAC Wound Dressing

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.

active comparator: Control Wound Dressing

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.

Interventions

Incisional Negative Pressure Wound Therapy (INPWT)

A total of 291 patients will be randomized to receive 7 days of Incisional Negative pressure wound dressing. The dressing will be removed 1 week after surgery.

Wound Dressing

A total of 291 patients will be randomized for standard gauze dressing. This dressing requires no pressure and is applied according to the current standard dressing procedures of the institution. The dressing will be changed every 2-3 days.

Primary outcome measure

  • Wound Complication including re-operation for superficial or deep site infection [ Time Frame: 120 days post op ]

Central Contacts and Locations

Central contacts

Yusra K Al-Mosuli

6137378920yalmosuli@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Yusra Al Mosuli

613-737-8920yalmosuli@ohri.ca

McGill University Health Center

Recruiting

Montreal, Quebec, Canada

Contacts

Yusra Al-mosuli

613-737-8920yalmosuli@ohri.ca

More Information

Sponsor

Dr. J. Werier

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

  • Sarcoma
  • Wound
  • Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. J. Werier on 2026-03-02.