Comparing Incisional Negative Pressure Wound with Wound Dressing for soft-tissue sarcoma
Official title: INPWT on Wound Complications & Clinical Outcomes After Lower Extremity Sarcoma Surgery Preop Radiation Therapy Patients
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
- 2 groups
- Sites in Ottawa and Montreal
- Recruiting
Interventions
- Other intervention
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 intervention
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.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
- Recruiting
McGill University Health Center
Montreal, Quebec
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients 18 years of age and older and are able to provide written consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +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.
- +Patient must be available for postoperative follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → at the treating center.
- +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.
Exclusion
- −Patients who have an allergy or sensitivity to adhesive dressings.
- −Patients who are less than 18 years of age.
- −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 with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Incisional Negative Pressure Wound Therapy (INPWT).
Registry label: A: VAC Wound Dressing
Group B, the comparison group, receives Wound Dressing.
Registry label: B: Control Wound Dressing
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 291 people.
The study is currently expected to finish around January 2028.
The main measurement is taken over: 120 days post op.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Wound Complication including re-operation for superficial or deep siteTrial siteA hospital or clinic where a study is actually run.Read more → infection — measured over 120 days post op.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03175718 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 120 days post op.
The study as a whole is currently expected to finish around 2028-01-28.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 291 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Ottawa, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.