Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery.

STUDY OBJECTIVE To perform the original phase I/II trial of autologous platelet tissue graft in gynecologic surgery to evaluate toxicity and efficacy on decreasing pain. DESIGN Prospective nonrandomized trial (Canadian Task Force classification II-A). SETTING Teaching hospital. PATIENTS Fifty-five consecutive patients undergoing major gynecologic surgery were entered into this prospective phase I/II trial and were matched with 55 patients from the previous 6 months. INTERVENTION After anesthesia was induced, peripheral venous blood (55 mL) was obtained from the patient producing, autologous platelet tissue graft (20 mL). At completion of surgery, autologous platelet tissue graft was directly applied to the surgical site. MEASUREMENTS AND MAIN RESULTS Median pain on the day of surgery was 2.7 (mild) in the autologous platelet tissue graft group vs 6.7 (severe) in the control group, p <.001. Likewise, pain on postoperative day 1 was 2.1 (mild) in the autologous platelet tissue graft group vs 5.5 (moderate) in the control group, p < or =.001. Median of morphine per hospital stay for the autologous platelet tissue graft group was 17 mg (range 1-98 mg) vs 26 mg (range 3-90 mg) in the control group, which was statistically significant at p = .02. There were no adverse effects associated with autologous platelet tissue graft. CONCLUSIONS In the original phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.