OTR4120: topical application to split-skin graft donor sites. A clinical evaluation on the healing.

Phase 3

Recruiting

• Conditions: burn wounds; donor skin; 10069888

• Registration Number: NL-OMON33585
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

1. Informed consent
2. Aged over 18 yrs
3. Patients in need of an autologous skin graft
4. Adequate nutritional state
5. Adequate immuno-competence
6. Women in reproductive age take contraceptive medication

Exclusion Criteria

1- Minor patients
2- Pregnant or breastfeeding women
3- Patients unable to sign the informed consent
4- Uninsured patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-Clinical improvement of the donor site wound, measured as reduction in wound<br /><br>size in time. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Complete healing of the wound, measured as the time needed for complete<br /><br>healing.<br /><br><br /><br>-Improvement of the quality of the (former) wound area to be measured as the<br /><br>amount of vascularisation, skin pigmentation and elasticity.<br /><br><br /><br>-Pain reduction.<br /><br><br /><br>-Itch reduction. </p><br>