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 adult 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 to 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 intramuscular route once daily, associated with a subcutaneous administration of 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 donor sites, which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation. Secondary end points were local subjective symptoms, such as pain and itching, and objective signs such as perilesional 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 re-epithelialisation was statistically significant (p < 0.008) in favour of the PDRN group. At the end of the observational period, between-group comparison demonstrated that patients treated with PDRN had a more prompt trophic effect. No adverse events were reported during the trial. CONCLUSIONS: The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts. This could improve the clinical outcome and decrease the need for additional therapies or hospital stay.
RCT Entities:
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 adult 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 to 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 intramuscular route once daily, associated with a subcutaneous administration of 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 donor sites, which was evaluated measuring wound surface area and then calculating percentage re-epithelialisation. Secondary end points were local subjective symptoms, such as pain and itching, and objective signs such as perilesional 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 re-epithelialisation was statistically significant (p < 0.008) in favour of the PDRN group. At the end of the observational period, between-group comparison demonstrated that patients treated with PDRN had a more prompt trophic effect. No adverse events were reported during the trial. CONCLUSIONS: The findings of our study demonstrated that PDRN is able to modify positively the repair processes in donor sites of autologous skin grafts. This could improve the clinical outcome and decrease the need for additional therapies or hospital stay.
Authors: E Raposio; C Guida; R Coradeghini; C Scanarotti; A Parodi; I Baldelli; R Fiocca; P L Santi Journal: Cell Prolif Date: 2008-07-31 Impact factor: 6.831