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Active, Not Recruiting

NCT Number: NCT07372404

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Nova

Jyväskylä, Finland, 40620

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinical evaluation

    Time frame: 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.

  2. The number adverse events, including deterioration of the wounds during the study.

    Time frame: 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)

  3. Clinical evaluation

    Time frame: Day 3, Day 7, Day 14

    The donor site wound physical characteristics will be recorded: moisture, colour, infection and hypergranulation

  4. Clinical imaging

    Time frame: 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.

  5. Clinical evaluation

    Time frame: Day 60

    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

Secondary outcomes

  1. Pain Intensity Measure

    Time frame: Day 3, Day 7, Day 14

    VAS Visual analogue scale (0-10 points)

  2. Clinical evaluation

    Time frame: 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.

  3. Fever (only symptomatic patients)

    Time frame: Day 3, Day 7, and Day 14

    Temperature (°C)

Sponsors and collaborators

Lead sponsor

Linio Biotech Oy

Industry

Collaborators

  • Hospital Nova, Central Finland

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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