Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation (NCT07372404) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation
Finland30 participantsStarted 2023-04-11
Plain-language summary
This study will evaluate the effect of an allogeneic adipose tissue extract on wound healing and scar maturation. Thirty adult patients scheduled for skin graft surgery will be enrolled. Each patient will have two skin graft donor sites harvested. One skin graft donor site wound will be treated topically with the adipose tissue extract, applied immediately after harvesting and reapplied on Day 3, while the other skin graft donor site wound will receive standard care. The main outcome is the time to complete epithelialization of the wound, as confirmed by investigators and independent reviewers. Secondary measures include wound characteristics, scar formation and scar quality, and monitoring of adverse events, such as wound deterioration.
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:
* Wound of at least 10 cm3 with an indication of skin graft surgery (two skin grafts harvested and used)
* Adult (age 18 years or more)
* Able and willing to give informed consent
* Reasonably accessible to the study clinic and compliant to wound treatment
Exclusion Criteria:
* Known allergy to any of the preparation used in the study (Tience)
* Systemic cancer (does not include carcinoma in situ of the cervix or local skin cancers such as basiloma)
* Pregnancy or nursing
* Those who withhold consent
* Active infection on the receptor site, donor site or sepsis
* Any other serious disease likely to compromise the outcome of the trial, such as critical renal disease (creatinine greater than 300 mmol/l)
* Those living at such a distance from the clinic as would make frequent assessment visits inappropriately expensive and/or impractical.
* Those with conditions, which tend to limit a patient´s ability or willingness to restrict activities or comply with the instructions during the treatment and follow-up period.
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
1
Clinical evaluation
Timeframe: Day 3, Day 7, Day 14, Day 60
2
The number adverse events, including deterioration of the wounds during the study.
Timeframe: Day 3, Day 7, Day 14, Day 60
3
Clinical evaluation
Timeframe: Day 3, Day 7, Day 14
4
Clinical imaging
Timeframe: Post op, Day 3, Day 7, Day 14, and Day 60