Chandanwale Ajay, Langade Deepak, Mohod Vaishali, Sinha Shyamal, Ramteke Alankar, Bakhshi G D, Motwani Madhur
Department of Traumatology and Orthopaedic Surgery, Grant Medical College and Sir JJ Group of Hospitals, Mumbai.
J Indian Med Assoc. 2008 Jun;106(6):405-8.
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.
本研究旨在比较局部应用人胎盘纯化提取物（胎盘凝胶）与聚维酮碘在骨科手术后的伤口愈合潜力方面的疗效和安全性。在这项开放性、对照、随机研究中，79名18岁以上接受择期清洁无污染骨科手术（开放性骨折复位、脊柱手术和伤口清创）的患者在获得书面知情同意后被纳入研究。根据计算机生成的随机分配表（Rando 1.2，2004），将入选患者随机分为两组，一组在手术伤口局部应用人胎盘纯化提取物（PE），另一组在手术伤口局部应用聚维酮碘（PI）软膏。术后，根据需要在第3天、第7天和第10天在手术伤口局部应用这两种制剂。在麻醉恢复后以及第3天、第7天和第10天，根据伤口愈合情况、医生对治疗反应的整体评估（PGART）量表、疼痛和不良反应对手术伤口进行评估。按照研究方案，所有79名患者（40名PE组和39名PI组）均在第10天完成了研究。所有患者的伤口均愈合。在第3天、第7天和第10天报告疼痛的患者数量在PE组和PI组中相似（p，0.527）。在第7天，PE组有6名患者（15.00%）出现伤口硬结，PI组有15名患者（38.46%）出现伤口硬结（p，0.041）。在研究期间，没有患者报告任何副作用/不良事件。纯化的胎盘提取物和聚维酮碘具有相当的伤口愈合效果。
