A randomized, controlled, double-blinded trial on the effects of acellular dermal matrices on the functional assessment and qualitative satisfaction of split-thickness skin grafts

Acellular dermal matrix (ADM) has been widely used in skin grafting to provide a dermal layer for facilitating graft take and mature scarring. This randomized controlled, double-blinded superiority study aimed to quantitatively assess the effects of this technique on the resulting graft sites via functional measurements including elasticity, humidification, transepidermal water loss (TEWL), pigmentation, and erythema at 6 months after surgery. A survey was performed to evaluate the satisfaction levels of both patients and surgeons. We considered patients with full-thickness skin defects for whom split-thickness skin grafts (STSGs) were used. By random assignment, they were allocated to the ADM group or the STSG-only group. The ADM group received STSG with a ADM layer on the defect, whereas the STSG-only group was reconstructed with only STSG. At 6 months after surgery, patients were evaluated for elasticity, humidification, TEWL, erythema, and pigmentation. Defect areas before and 2 weeks after surgery were traced and measured. Patients and surgeons rated the graft sites as excellent, good, fair or poor at 6 months after the operation. Among the 89 patients who were screened, 54 patients were enrolled in this study. Compared with those in the STSG-only group, defects that were reconstructed with STSG and ADM resulted in significantly greater elasticity, lower TEWL, and less erythema. There were no significant differences in humidification or pigmentation. The ADM co-grafted with STSGs was associated with greater satisfaction among surgeons, whereas patient satisfaction was not significantly different between the two groups. Co-grafting ADM with STSG in full-thickness wounds can lead to favorable wound healing in terms of elasticity, TEWL, and erythema. This approach also has a higher satisfaction rate for surgeons.Registry: Clinical Research Information Service ( https://cris.nih.go.kr ), Registration number: KCT0007040, Registration date: 24/02/2022.