A phase 2a, multi-centre, controlled study of the safety and efficacy of wound healing gel I-020502 in patients undergoing autologous meshed skin grafting. - Acute Wounds

• Conditions: Deep partial-thickness and full-thickness burns require grafting procedures to achieve wound healing and closure.Autologous grafting eliminates the risk of transmissible diseases but may be complicated by hematoma formation, infection and mechanical disruption. In large total body surface area burns, the skin donor site is quickly exhausted. Meshed skin autografts become a convenient alternative for which the use of I-020502 will be investigated.; MedDRA version: 8.1Level: LLTClassification code 10053615Term: Thermal burn

• Registration Number: EUCTR2006-005092-18-DE
• Lead Sponsor: KUROS BIOSURGERY AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Written informed consent by the patient or his/her legal representative.
2.Male or female, aged = 18 years
3.Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
4.Patients with burn wound(s) between = 10 % and = 30 % TBSA.
5.Patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% TBSA but not more than 400 sqcm.
6.Patients who are willing to comply with treatment applications and instructions by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Females who are pregnant or breast-feeding.
2.Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
3.Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
4.Electrical and/or chemical burns.
5.Patients that are judged to have significant pulmonary compromise.
6.Transcutaneous tissue oxygenation < 90%.
7.Clinically significant infections at wound sites.
8.Clinically significant systemic infections.
9.Suspicion or presence of active systemic or local cancer or tumor of any kind.
10.Patients with known immunodeficiency disorders, either congenital or acquired.
11.Patients with vascular or skin disorders that directly affect the designated wound site.
12.Patients with Diabetes mellitus.
13.Patients with chronic malnourishment.
14.Chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery.
15.Any other acute or chronic concurrent medical conditions that in the Investigator’s opinion are a contraindication to skin mesh grafting and study participation.
16.Participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified