title: Phase I/II prospective trial of autologous platelet tissue graft in gynecologic surgery.
abstract: 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.
  
  
  METHODS
  Prospective nonrandomized trial (Canadian Task Force classification II-A).
  
  
  METHODS
  Teaching hospital.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  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.
authors.affiliation: Department of Obstetrics and Gynecology, Summa Health System, Northeastern Ohio Universities College of Medicine, Akron, Ohio 44309, USA. fanning@summa-health.org
authors.forename: James
authors.initials: J
authors.lastname: Fanning
authors.forename: Luis
authors.initials: L
authors.lastname: Murrain
authors.forename: Robert
authors.initials: R
authors.lastname: Flora
authors.forename: Timothy
authors.initials: T
authors.lastname: Hutchings
authors.forename: Jil M
authors.initials: JM
authors.lastname: Johnson
authors.forename: Bradford W
authors.initials: BW
authors.lastname: Fenton
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000628:therapy*; D053657:Platelet-Rich Plasma / Q000502:physiology*; D014182:Transplantation, Autologous / Q000009:adverse effects* / Q000379:methods