Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

NCT07372404 | Active Not Recruiting

• 1 other identifier: CT-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Keywords

allogeneic tissue product; adipose-derived tissue; skin graft donor site; split-thickness skin graft; epithelialization; wound assessment; scar quality; scar maturation; scar thickness

Outcome Measures

Primary Outcomes (5)

• 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. * Adverse events, including deterioration of wounds * Severe wound complications (necrosis, infection)

  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

  Day 60

Secondary Outcomes (3)

• Pain Intensity Measure

  Day 3, Day 7, Day 14

• Clinical evaluation

  Day 60

• Fever (only symptomatic patients)

  Day 3, Day 7, and Day 14

Study Arms (1)

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.

Procedure: Topical treatment

Interventions

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.

Adipose tissue extract treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Linio Biotech Oy: lead
• Hospital Nova of Central Finland: collaborator

Study Sites (1)

Hospital Nova

Jyväskylä, Finland, 40620, Finland

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and outcome independent evaluators are blinded.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: April 11, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FI (1)