Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

The Effect of Allogeneic Human Fat-Derived Extract on Skin Graft Donor Site Wound Healing

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Procedure: Topical treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Finland
    • Jyväskylä, Finland, Finland, 40620
      • Hospital Nova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adipose tissue extract treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; 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 Outcome Measures

Outcome Measure	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.	Day 60
Fever (only symptomatic patients)	Temperature (°C)	Day 3, Day 7, and Day 14

Collaborators and Investigators

• Sponsor: Linio Biotech Oy
• Collaborators: Hospital Nova of Central Finland

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: split-thickness skin graft; skin graft donor site; scar quality; wound assessment; epithelialization; scar thickness; allogeneic tissue product; adipose-derived tissue; scar maturation
• Additional Relevant MeSH Terms: Therapeutics
• Other Study ID Numbers: CT-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No