MedPath

A randomized controlled trial comparing autologous platelet rich plasma versus only standard treatment for treating burn wounds

Phase 4
Completed
Conditions
burns
full thickness
10014982
Registration Number
NL-OMON35701
Lead Sponsor
Rode Kruis Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
52
Inclusion Criteria

1. Adult men and women aged 18 years and older (no upper age limit)
2. A full thickness burn which needs primary or secondary transplantation
3. provision of informed consent by patient

Exclusion Criteria

1.Likely problems, in the judgement of the investigators, with maintaining follow-up (e.g.patients with no fixed adress will be excluded)
2. Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information in the judgement of the attending physician.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study endpoint is the effect of PRP on the time in days to complete<br /><br>healing of the grafted butn wound sites.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>1. Infection rate of the transplanted burn wounds in comparison with standard<br /><br>treatment.<br /><br>2. Pain meassured daily with a VAS scale to complete healing of the paired<br /><br>grafted burn wound sites.<br /><br>3. Scar assessment with the POSAS scale in comparsion with standard treatment<br /><br>after 3, 6 months and one year. </p><br>
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