INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients (VAC)
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|ClinicalTrials.gov Identifier: NCT03175718|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 2, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Soft-tissue Sarcoma Wound Complication||Other: Incisional Negative Pressure Wound Therapy (INPWT) Other: Wound Dressing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||The Effect of INPWT on Wound Complications and Clinical Outcomes Following Lower Extremity Sarcoma Surgery in Patients Treated With Preoperative Radiation Therapy: A Multicentre Randomized Controlled Trial|
|Actual Study Start Date :||February 1, 2022|
|Estimated Primary Completion Date :||April 29, 2025|
|Estimated Study Completion Date :||April 28, 2026|
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.
Other: 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.
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.
Other: 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.
- Wound Complication including re-operation for superficial or deep site infection [ Time Frame: 120 days post op ]
- 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.
- patient satisfaction [ Time Frame: All within this 120 day post-op ]Patient satisfaction will be evaluated by validated questionnaires.
- Functional outcome [ Time Frame: 120 days postop ]Secondary outcomes include length of stay in hospital,
- Overall cost [ Time Frame: 120 days ]A cost analysis will be performed by evaluating the average inpatient cost per day, number of emergency department and clinic visits, cost of secondary procedures cost of INPWT and cost of home care visits.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175718
|Contact: Yusra K Al-Mosuli||6137378920 ext firstname.lastname@example.org|
|The Ottawa Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Yusra Al Mosuli 613-737-8920 ext 74709 email@example.com|
|McGill University Health Center||Recruiting|
|Montréal, Quebec, Canada|
|Contact: Yusra Al-mosuli 613-737-8920 firstname.lastname@example.org|
|Principal Investigator:||Joel Werier||Surgeon|
|Responsible Party:||Dr. J. Werier, Orthopedic Oncologist Surgeon, Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||June 5, 2017 Key Record Dates|
|Last Update Posted:||March 2, 2022|
|Last Verified:||February 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Wounds and Injuries
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type