UnknownEarly Phase 1

Biological Skin Graft With Keratinocyte-stem Cell Co-cultre for Burn Patients

Indonesia20 participantsStarted 2022-09-06

Plain-language summary

The goal of this clinical trial is to test whether artificial skin graft can substitute autologous skin graft in current burn treatment. The main question it aims to answer is: • Can artificial skin graft result in better wound healing compared to the current burn treatment; autologous skin graft? You will: * Undergo debridement surgery * Receive artificial skin graft as an alternative to autologous skin graft * Undergo biopsy procedure of burn area If there is a comparison group: Researchers will compare autologous skin graft group to see the wound healing process

Who can participate

Age range

18 Years – 55 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: * Aged 18 - 55 * Area of burn \<50% * Acute phase burn (\<120 hrs) * Have not undergo any surgery for burn treatment Exclusion Criteria: * Immunocompromised * Have comorbidities

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

Burn thickness

Timeframe: Day of surgery

Burn thickness

Timeframe: Day 7 after surgery

Burn thickness

Timeframe: Day 14 after surgery

Burn thermography

Timeframe: Day of surgery

Burn thermography

Timeframe: Day 7 after surgery

Burn thermography

Timeframe: Day 14 after surgery

Systemic clinical evaluation

Timeframe: Day of surgery

Systemic clinical evaluation

Timeframe: Day 7 after surgery

Trial details

NCT IDNCT05652816

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Burn Degree Second trials

Plain-language summary

Who can participate

Age range

18 Years – 55 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: * Aged 18 - 55 * Area of burn \<50% * Acute phase burn (\<120 hrs) * Have not undergo any surgery for burn treatment Exclusion Criteria: * Immunocompromised * Have comorbidities

What they're measuring

Burn thickness

Timeframe: Day of surgery

Burn thickness

Timeframe: Day 7 after surgery

Burn thickness

Timeframe: Day 14 after surgery

Burn thermography

Timeframe: Day of surgery

Burn thermography

Timeframe: Day 7 after surgery

Burn thermography

Timeframe: Day 14 after surgery

Systemic clinical evaluation

Timeframe: Day of surgery

Systemic clinical evaluation

Timeframe: Day 7 after surgery