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

NCT03452852 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-03-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PICO

NPWT with PICO (Smith and Nephew)

OTHER

Coban 2 lite

Compression bandaging with Coban 2 lite

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452852 on ClinicalTrials.gov