The effect of locally applied platelet-rich fibrin on donor sites and recipient sites after split-thickness skin transplantatio

Completed

• Conditions: Chronic leg ulcer; Circulatory System

• Registration Number: ISRCTN01737461
• Lead Sponsor: Vivolution A/S (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Patients undergoing surgery for chronic leg ulcer
2. Aged over 18 years
3. Written informed consent, the patient is expected to be able to complete the study
4. Donor site area from 2 x (3 cm x 5 cm) to 2 x (7.6 cm x 15 cm)

Exclusion Criteria

1. Non-Danish speaking
2. Dementia
3. Pregnant or breastfeeding women
4. Patients treated with 10 mg of steroid or more daily
5. Patients that have received thrombocyte-inhibiting medicine less than four days before surgery
6. Patients not suited for general or spinal anaesthesia
7. Patients whose donor site has been used as a donor site before
8. Patients with skin diseases or pathological changes in the skin, including infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epithelialization on day five and nine post-operatively

Secondary Outcome Measures

Name	Time	Method
1. Clinical appearance<br>2. Histological evaluation<br>3. Transepidermal Water Loss (TEWL)<br>4. Erythema<br>5. Microbiology<br>6. Incidence of infection<br>7. Unwanted side effects<br>8. Temperature difference between treated patients and control group patients