Wound Healing
Conditions
Keywords
allogeneic tissue product, adipose-derived tissue, skin graft donor site, split-thickness skin graft, epithelialization, wound assessment, scar quality, scar maturation, scar thickness
Brief 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.
Detailed description
Cell-free preparate of human adipose tissue is intended to be used in the human body for its original purpose to supplement and replace local extracellular matrix deficiencies in soft tissue, including skin. The tissue product provides a temporary conductive environment into the injured area. This facilitates the ability of local cells to re-populate the damaged soft tissue and skin area, thereby enabling the deposition of extracellular matrix and repair of the tissue.
Interventions
PROCEDURETopical treatment
The adipose tissue extract will be applied topically to one skin graft donor site wound immediately after harvesting and reapplied on Day 3. The other donor site will receives standard wound care according to hospital protocol, without application of adipose tissue extract. Wounds will be photographed and assessed on Days 3, 7, 14, and 60. Study participants and independent evaluators are blinded to treatment allocation.
Sponsors
Linio Biotech Oy
Hospital Nova of Central Finland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants and outcome independent evaluators are blinded.
Intervention model description
Participants are not randomized into different arms. Each participant will have two skin graft donor sites harvested. One donor site wound will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3, while the other donor site wound will receive standard care. Photographic documentation and clinical evaluation of the donor site wounds will be performed on Days 3, 7, 14, and 60 to monitor wound healing progression. Study participants and independent evaluators are blinded to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical evaluation | Day 3, Day 7, Day 14, Day 60 | The primary efficacy end point will the wound healing time during this study period, in days. Healing will be defined as complete epithelialization (mm paper, photographs), confirmed by an investigator and independent evaluators. The comparison will be made between the donor site treated with allogeneic adipose tissue extract (ATE) and the untreated donor site (standard care) within the same participant. |
| The number adverse events, including deterioration of the wounds during the study. | Day 3, Day 7, Day 14, Day 60 | The primary safety end points will be the number adverse events, including deterioration of the wounds during the study. * Adverse events, including deterioration of wounds * Severe wound complications (necrosis, infection) |
| Clinical imaging | Post op, Day 3, Day 7, Day 14, and Day 60 | Digital photographs will be taken to document the progression of wound healing. One or two blinded plastic surgeons, with no conflicts of interest, will evaluate the donor site wounds and scars based on these photographs. They will assess and compare the donor sites treated with allogeneic adipose tissue extract (ATE) and those treated with standard care, as well as the resulting scars, using the photographic documentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measure | Day 3, Day 7, Day 14 | VAS Visual analogue scale (0-10 points) |
| Clinical evaluation | Day 60 | Scar quality will be assessed using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool that evaluates scars from both the clinician's and the patient's perspectives. The POSAS scale includes seven parameters-each rated from 1 (normal skin) to 10 (worst scar imaginable). The Scale assesses pain, itching, color, stiffness, thickness, irregularity, and overall impression. |
| Fever (only symptomatic patients) | Day 3, Day 7, and Day 14 | Temperature (°C) |
Countries
Finland
Contacts
CONTACTMinna Höst, Clinical Study Coordinator
CONTACTJenny Lopez, Plastic Surgery Specialist
Outcome results
None listed