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| Name | Class |
|---|---|
| Hospital Nova, Central Finland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adipose tissue extract treatment | Experimental | Study participants will have two skin graft donor sites harvested. One donor site will be treated topically with adipose tissue extract immediately after harvesting and again on Day 3. The other skin graft donor site wound will receive standard of care, following the hospital's Current Care Guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation | 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. | Day 3, Day 7, Day 14, Day 60 |
| The number adverse events, including deterioration of the wounds during the study. | The primary safety end points will be the number adverse events, including deterioration of the wounds during the study.
| Day 3, Day 7, Day 14, Day 60 |
| Clinical evaluation | The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation | Day 3, Day 7, Day 14 |
| Clinical imaging | 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. | Post op, Day 3, Day 7, Day 14, and Day 60 |
| Clinical evaluation | Scar scaling, modified Vancouver burn scale consists of six items. All items are scored on a scale ranging from 1 ('like normal skin') to 3 ('worst scar imaginable'). • Vascularity category: pale, pink, red, normal • Pigmentation category: hypo, hyper, normal • Height: plane, depressed, elevated • Matte vs. shine: shine, matte • Contour: forms part of the adjacent skin, small indentation or invagination • Texture: normal, barely palpable, rough, indented |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Measure | VAS Visual analogue scale (0-10 points) | Day 3, Day 7, Day 14 |
| Clinical evaluation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nova | Jyväskylä | Finland | 40620 | Finland |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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Participants and outcome independent evaluators are blinded.
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| Day 60 |
| Day 60 |
| Fever (only symptomatic patients) | Temperature (°C) | Day 3, Day 7, and Day 14 |