Comparative evaluation of human placental extract for its healing potential in surgical wounds after orthopaedic surgery: an open, randomised, comparative study.

The study was conducted to compare the efficacy and safety of topical application of purified extract of human placenta (placentrex gel) versus povidone iodine for its wound healing potential after orthopaedic surgeries. In this open, comparative, randomised study, 79 patients above 18 years of age undergoing elective clean and uncontaminated orthopaedic surgery (open fracture reduction, spine surgery and debridement of wound) were enrolled in the study after obtaining written informed consent. Enrolled patients were randomised as per the PC generated randomisation chart (Rando 1.2, 2004) to receive either topical application of human placenta purified extract (PE) on the surgical wound or topical application of povidone iodine (PI) ointment on the surgical wound. Both preparations were applied topically on the surgical wound after the surgery, on days 3, 7 and on day 10, if required. Assessment of surgical wound was done after recovery from anaesthesia and on days 3, 7 and 10 based upon wound healing, physicians' global assessment of response to therapy (PGART) scale, pain and adverse effects. All 79 patients (40 PE and 39 PI) completed the study on day 10 as per the study protocol. Healing of the wound was observed in all patients. The number of patients reporting pain on days 3, 7 and 10 were similar in both PE and PI treatment (p, 0.527) groups. Wound induration was observed in 6 patients (15.00%) of PE and 15 (38.46%) of PI on day 7 (p, 0.041). None of the patients reported any side/adverse events during the study period. Purified placental extract and povidone iodine have comparative wound healing effects.

RCT Entities:   Population Interventions Outcomes