Soft-tissue SarcomaVACNCT03175718
INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
A study testing Incisional Negative Pressure Wound Therapy (INPWT) and Wound Dressing in people with Soft-tissue Sarcoma and Wound Complication, run by Dr. J. Werier at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft-tissue Sarcoma, Wound Complication
- What is being tested?
- Incisional Negative Pressure Wound Therapy (INPWT) and Wound Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Feb 2022to 28 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec
Yusra Al-mosuli, 613-737-8920, yalmosuli@ohri.ca
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Yusra Al Mosuli, 613-737-8920 ext. 74709, yalmosuli@ohri.ca
About this study
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
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.
Read the detailed description
This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.
- Conditions
- Soft-tissue Sarcoma, Wound Complication
- Being tested
- Incisional Negative Pressure Wound Therapy (INPWT), Wound Dressing
- Keywords
- Sarcoma, Wound, Therapy
- Medical subject headings
- Sarcoma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Wound DressingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days post op
Secondary outcomes (3)
patient satisfaction
Patient satisfaction will be evaluated by validated questionnaires.
Measured: All within this 120 day post-op
Functional outcome
Secondary outcomes include length of stay in hospital,
Measured: 120 days postop
Overall cost
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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Feb 2022
- Primary completionJan 2028 (estimated)
- Study completion28 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft-tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. J. Werier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. J. Werier, Ottawa Hospital Research Institute
- Investigators
- Joel Werier, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175718
- Sponsor's protocol ID
- 20170154
- Acronym
- VAC
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2017
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03175718
- Acronym / sponsor ID
- VAC / 20170154
- Conditions
- Soft-tissue Sarcoma, Wound Complication
- Keywords
- Sarcoma, Wound, Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Dr. J. WerierUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 28 Jan 2028 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VAC Wound Dressing | Experimental | Other: Incisional Negative Pressure Wound Therapy (INPWT)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. |
| Control Wound Dressing | Active comparator | Other: Wound DressingLimb 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | VAC Wound Dressing |
| Wound DressingA 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. | Other | Control Wound Dressing |
Primary outcome
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.
3 secondary outcomes
patient satisfaction
Time frame: All within this 120 day post-op
Functional outcome
Time frame: 120 days postop
Overall cost
Time frame: 120 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joel Werier principal investigator
Surgeon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional Negative Pressure Wound Therapy (INPWT) and Wound Dressing in people with Soft-tissue Sarcoma and Wound Complication, run by Dr. J. Werier at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusra K Al-Mosuli (6137378920 ext. 74709, yalmosuli@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Complication including re-operation for superficial or deep site infection (time frame: 120 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.