Safety and Efficacy of I-020502 in Meshed Skin Autografting (NCT00471939) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of I-020502 in Meshed Skin Autografting
Germany10 participantsStarted 2007-04
Plain-language summary
This is a phase II, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of I-020502 in a concentration of 1μg/mL TG-PDGF.AB versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent by the patient or his/her legal representative.
✓. Male or female, aged ≥ 18 years.
✓. Female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening).
✓. Patients with burn wound(s) between ≥ 5 % and ≤ 50 % TBSA.
✓. 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 cm2.
✓. Patients who are willing to comply with treatment applications and instructions by the protocol.
Exclusion criteria
✕. Females who are pregnant or breast-feeding.
✕. Patients with known or suspected allergies to any of the components of the wound healing gel I-020502 (e.g. hypersensitivity to bovine proteins).
✕. Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites.
✕. Electrical and/or chemical burns.
✕. Patients that are judged to have significant pulmonary compromise.
✕. Transcutaneous tissue oxygenation \< 90%.
What they're measuring
1
Incidence of treatment-related adverse events up to 28 days post surgery