Clinical trial · Interventional
Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall.
Effect of Negative Pressure Wound Therapy After Surgical Removal of Deep-Seated High-Malignant Soft Tissue Sarcomas of the Extremities and Trunk Wall. A 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)
The purpose of this research project is to improve the surgical treatment of Soft Tissue Sarcoma (STS) treatment based upon a Randomized Controlled Trial (RCT). We want to evaluate the effect of the use of Negative Pressure Wound Therapy (NPWT) versus a conventional wound dressing on postoperative wound complications after surgical removal of deep-seated high-malignant STS of the extremities or trunk wall.
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 |
| Neoplasms, Connective and Soft Tissue | Connective and Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prevena | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard treatment
- description
- Group A: Standard wound closure with staples and conventional wound dressing.
- type
- EXPERIMENTAL
- label
- Prevena
- description
- Group B: Wound closure with staples and Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System).
- interventionNames
- Device: Prevena
Primary outcomes (1)
- measure
- Wound complication/healing
- timeFrame
- 120 days postoperatively
- description
- A major wound complication defined as in O'Sullivan et al. \[11\]: * A secondary surgery under anesthesia for wound repairs such as debridement, operative drainage and secondary wound closure. * Wound management without secondary surgery, this includes invasive procedure without anesthesia such as aspiration of seroma and readmission for wound care such as intravenous antibiotic or persistent deep packing within 4 months (120 days) after surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Surgery for a deep-seated STS of an extremity or the trunk wall at Rigshospitalet. Exclusion Criteria: * Age \< 18 years * Wound closure not possible without plastic surgery (pedicled or free flaps) * Low malignant (Trojani grade 1) STS or borderline tumors * Pre- or postoperative chemotherapy * Preoperative radiotherapy to the local site. * Allergic or hypersensitive to acrylic adhesives or silver * Unwilling or unable to provide informed consent * Inability to comply with planned study procedures * Patients with metastatic disease. * Patients with ischemic surgery such as bypass or endovascular prosthesis
References
Publications (1)
- DERIVEDYilmaz M, Thorn A, Sorensen MS, Jensen CL, Petersen MM. Effect of negative pressure wound therapy after surgical removal of deep-seated high-malignant soft tissue sarcomas of the extremities and trunk wall-study protocol for a randomized controlled trial. Trials. 2022 Jun 18;23(1):507. doi: 10.1186/s13063-022-06468-6. PMID 35717239