Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft-tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Incisional Negative Pressure Wound Therapy (INPWT) | Other | — | UNRESOLVED |
| Wound Dressing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VAC Wound Dressing
- description
- 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.
- interventionNames
- Other: Incisional Negative Pressure Wound Therapy (INPWT)
- type
- ACTIVE_COMPARATOR
- label
- Control Wound Dressing
- description
- 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.
- interventionNames
- Other: Wound Dressing
Primary outcomes (1)
- measure
- Wound Complication including re-operation for superficial or deep site infection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available