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.

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.

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.