AMNIOTIC TISSUE ALLOGRAFT IN TREATMENT OF NON-HEALING WOUND.
STRYJA JAN, SALVATELLA LTD., CZECH REPUBLIC
Amniotic tissue allograft (ATA) dressings1 represent a novel choice for local treatment of non-healing wounds in the Czech Republic. The aim of the observational study is to assess the effectiveness of treatment realized by lyophilized amniotic tissue allografts.
In a prospective observational multi-centric study, amniotic membrane dressing was applied to non-healing wounds referred to eight selected wound clinics across Czech and Slovak Republic for aggressive management, after prior, traditional treatment methods were found ineffective. Amniotic membrane was changed once a week until the wound has healed. Patients has been studied for 16 weeks. Wound closure has been set as the endpoint of the study. The effectiveness of the treatment has been evaluated according to the wound bed evolution, the number of applications of a dehydrated amniotic membrane allograft necessary for wound closure, and documented healing time. Included subjects consisted of DFU patients (n=24) and non-DFU patients (n=26). ATA treatment was concluded when the wound bed was totally covered by epithelium, or when serious health problems occurred. We monitored the ulcer area, wound bed trait, number of ATA dressing changes, the length of treatment, intensity of pain (VAS scale) and presence of complications.
In diabetic foot ulcer group (n=26) we reached compete wound closure in 10 cases (38%), in 9 wounds (35%) the ulcer area has decreased and in 5 (19%) cases we observed stagnation or increased wound area by the end of study period. In non-diabetic foot ulcer group (n=24) we have reached compete wound closure in 8 cases (33%), in 12 (50%) wounds the ulcer area has decreased and in 6 (25%) cases we observed stagnation or increased wound area. We have found comparable clinical efficacy of DFU and non-DFU treatment by ATA (statistically non-significant (NS) differences). We have observed decrease of the VAS score during the ATA treatment (from VAS 5 to VAS 1). The average number of ATA applications in DFU group was 11, in non-DFU group it was 9 applications.
Wounds treated with the amniotic membrane allograft demonstrated good healing potential. There was not any statistically singificant difference in clicical efficacy of ATA treatment between DFU and non-DFU group. We have reached 79% improvement in DFU group and 77ˇ% improvement in non-DFU group.