Prospective, RCT of Split Thickness Skin Grafts on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT

NCT03452852 — Not applicable, Unknown, 60 participants, Oslo University Hospital

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Prospective, Randomized Study of Split Thickness Skin Graft in Wounds on Lower Leg After Compression Therapy With Compression Bandage vs. NPWT

Registry	NCT03452852
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Oslo University Hospital (Other)
Conditions	Skin Cancer
Interventions	PICO, Coban 2 lite (Device, other)
Dates	start 2018-03-01 (estimated), primary completion 2019-12-31 (estimated), completion 2019-12-31 (estimated), first posted 2018-03-02, last updated 2018-03-02
Locations	1 site in Norway

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
NPWT (PICO device)	Other	Device: PICO	In this arm, investigators will use the PICO system (Smith and Nephew) for compression therapy after split thickness skin graft of leg ulcers.
Compression bandaging (Coban 2 lite)	Other	Other: Coban 2 lite	In this arm, investigators will use the Coban 2 lite compression bandaging for compression therapy after split thickness skin graft of leg ulcers.

PICO (Device): NPWT with PICO (Smith and Nephew)
Coban 2 lite (Other): Compression bandaging with Coban 2 lite

+Outcome measures

Primary outcomes

Healing of skin graft between the two Methods [30 days postoperatively]: Numbers of patients with 100 % healing of the split thickness skin graft

Secondary outcomes

Percentage of healing between the two Methods [30 days postoperatively]: Average healing of the split thickness skin grafts
Evaluation of pain with VAS (Visual analogic scale) [0, 5-7, 10-14 and 30 days postoperatively]: Pain score as measured by VAS
Level of function [30 days postoperatively]: Evaluate change in daily function after surgery

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Department of Plastic- and Reconstructive Surgery, Oslo university hospital - Rikshospitalet	Oslo	Norway	Recruiting

+Investigators

Thomas Moe Berg, MD, PhD, Principal investigator, Department of Plastic- and reconstructive surgery, Oslo university hospital - Rikshospitalet, Oslo, Norway

My Notes

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