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 range18 Years – 55 Years

SexALL

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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

Systemic clinical evaluation

Timeframe: Day 14 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