Clinical trial · Interventional
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds. A Prospective Randomized Clinical 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)
This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound. The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Infectious Disease | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prevana Dressing | Device | — | UNRESOLVED |
| Standard Dry Gauze Dressing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NPWT dressing
- interventionNames
- Device: Prevana Dressing
- type
- PLACEBO_COMPARATOR
- label
- Standard dry gauze dressing
- interventionNames
- Other: Standard Dry Gauze Dressing
Primary outcomes (1)
- measure
- Wound Complication Rate
- timeFrame
- longitudinally up to 6 months postoperatively
- description
- To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 * Willing to consent to randomization and able to participate in the study * Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection * Primary closure of wound * Patients scheduled for surgical resection Exclusion Criteria: * Flap coverage or skin graft * Patients scheduled for amputations as local control of their tumor * Sarcomas where radiation is not planned preoperatively * Repeat surgeries for oncologic reasons (positive margins) * Known allergy to adhesive tape
References
Publications (0)
Data not yet available