Clinical evaluation of the trophic effect of polydeoxyribonucleotide (PDRN) in patients undergoing skin explants. A pilot study

Objective: The purpose of this double-blind, randomised, placebo-controlled study was to assess the effects of intramuscular and subcutaneous PDRN in favouring the wound-healing process in donor sites of grafts. Methods: 26 a dult patients of both sexes (15 males and 11 females; mean age: 68.2 +/- 16 .1 years) subjected to skin explants due to plastic surgery were eligible t o participate in this double-blind, placebo-controlled study. Patients were randomly allocated into the PDRN group (14 subjects) or the placebo group (12 subjects). PDRN (5625 mg/vial) or placebo were administered by the intr amuscular route once daily, associated with a subcutaneous administration o f the same dosage form (2 vials every 3 days) for 10 consecutive days. The primary end point for efficacy was the evolution of wound healing in do nor sites, which was evaluated measuring wound surface area and then calcul ating percentage re-epithelialisation, Secondary end points were local subj ective symptoms, such as pain and itching, and objective signs such as peri lesional erythema and blisters. Signs and symptoms were quantified through an analogue scale. Results:At day 7 of the treatment period, the difference in percentage of r e-epithelialisation was statistically significant (p < 0.008) in favour of the PDRN group. At the end of the observational period, between-group compa rison demonstrated that patients treated with PDRN had a more prompt trophi c effect. No adverse events were reported during the trial. Conclusions: The findings of our study demonstrated that PDRN is able to mo dify positively the repair processes in donor sites of autologous skin graf ts. This could improve the clinical outcome and decrease the need for addit ional therapies or hospital stay.