Clinical trial · Interventional
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery
SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Controlled Study to Evaluate the Wound Management in Sarcoma Surgery
- 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 aim of this study is to evaluate local complications following sarcoma resection in the groin and thigh regions with regard to the planned wound closure method. To this end, temporary soft tissue coverage using a vacuum-assisted closure (VAC) system and delayed secondary closure with wound sutures and drainage placement will be compared to primary closure with drainage in terms of wound infections, revisions, and seroma formation.
Conditions
Conditions (1)
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 (STS) | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- description
- Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.
- interventionNames
- Procedure: Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Control Group: In this group, wound closure is performed using primary sutures or staples, combined with the placement of a subcutaneous Redon drainage system.
Primary outcomes (6)
- measure
- Wound complication
- timeFrame
- 3 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must be over 18 years old. * Patients of any gender and background can be included. * The largest tumor diameter on imaging must be at least 5 cm. Preoperative imaging is required to assess tumor dimensions. * Sarcomas must be located in the lower extremity or groin. * Cases must be discussed preoperatively at an interdisciplinary tumor board. * Patients must provide informed consent to participate in the study. Exclusion Criteria: * Tumors smaller than 5 cm and superficial masses. * Patients with local recurrences or prior wound healing complications in the surgical area. * Patients with ulcerating or infected tumors, or those requiring emergency surgery. * Other Soft Tissue Tumors such as Kaposi sarcoma. * for whom direct closure is not possible during the initial surgery due to the extent of resection.
References
Publications (0)
Data not yet available