Clinical trial · Interventional
Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT
- 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 single center, prospective, randomized trial includes in total 60 patients. We want to compare two different treatment methods for compression therapy for split thickness skin graft in lower leg. The patients are randomized to compression therapy with NPWT (negative pressure wound therapy) using the device PICO or using the compression bandage with Coban 2 lite. Primary outcome is complete healing of the skin transplant 30 days postoperatively. Secondary outcomes will be to note frequency of infection, bleeding, loss of transplant etc.
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 |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Coban 2 lite | Other | — | UNRESOLVED |
| PICO | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- NPWT (PICO device)
- description
- In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
- interventionNames
- Device: PICO
- type
- OTHER
- label
- Compression bandaging (Coban 2 lite)
- description
- In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.
- interventionNames
- Other: Coban 2 lite
Primary outcomes (1)
- measure
- Healing of skin graft between the two Methods
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 years * Signed informed consent * Surgical wound (excision of skin cancer) Exclusion Criteria: * Malignant melanoma * Signs of infection * Exposed tendon/bone in wound * Burn/chronic wound
References
Publications (0)
Data not yet available