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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment-related adverse events up to 28 days post surgery

Timeframe: 28 days

Trial details

NCT IDNCT00471939

SponsorKuros Biosurgery AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-12

View on ClinicalTrials.gov More Burns trials