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

NCT03175718 | Recruiting DMC

• 1 other identifier: 20170154
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 2

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

Keywords

Sarcoma; Wound; Therapy

Outcome Measures

Primary Outcomes (1)

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

  * Wound requiring deep wound packing to an area greater than 2cm in length * Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.

  120 days post op

Secondary Outcomes (3)

• patient satisfaction

  All within this 120 day post-op

• Functional outcome

  120 days postop

• Overall cost

  120 days

Study Arms (2)

VAC Wound Dressing

EXPERIMENTAL

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.

Other: Incisional Negative Pressure Wound Therapy (INPWT)

Control Wound Dressing

ACTIVE COMPARATOR

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.

Other: Wound Dressing

Interventions

Wound Dressing OTHER

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.

Control Wound Dressing

Incisional Negative Pressure Wound Therapy (INPWT) OTHER

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.

VAC Wound Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. J. Werier: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

McGill University Health Center

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Sarcoma; Wounds and Injuries

Interventions

Bandages

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Joel Werier

  Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yusra K Al-Mosuli

CONTACT

6137378920; yalmosuli@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operative team will remain blinded to the dressing until the time of application. Since wound failure requires the need of medical or surgical intervention, primary outcome of this study is not blinded. However, the treatment arm will be blinded to the Research Coordinator/Outcomes Assessor of secondary outcomes including scar assessment, QoL and Functional Assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Oncologist Surgeon

Model Details: This is a Canadian multicenter superiority randomized clinical trial in patients who are scheduled to undergo surgical resection of a soft tissue sarcoma treated with either preoperative or postoperative radiation therapy and a primary closure. The participants are randomized to Incisional Negative Pressure Wound Therapy (Acelity) or conventional gauze dressing; the current standard of care.

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: June 5, 2017
• Study Start: February 1, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 28, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)