Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

N/AActive Not RecruitingNCT07372404

Linio Biotech Oy30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wound Healing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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)

Time frame: Day 3, Day 7, Day 14, Day 60

Clinical evaluation

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

Time frame: 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.

Time frame: 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

Time frame: Day 60

Secondary Outcomes

Pain Intensity Measure

VAS Visual analogue scale (0-10 points)

Time frame: 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.

Time frame: Day 60

Fever (only symptomatic patients)

Temperature (°C)

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

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes