Michael C F Tong1, Virgil Yue, Peter K M Ku, C Andrew van Hasselt. 1. Division of Otorhinolaryngology, Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territory, Hong Kong, People's Republic of China.
Abstract
OBJECTIVE: To establish the efficacy of immediate preoperative ototopical ofloxacin eardrops in eradicating middle ear pathogens and improving operative outcome. STUDY DESIGN: Single-blind, randomized control study. SETTING:Tertiary referral center, ambulatory clinic, and hospital setting. PATIENTS: Consecutive patients with chronic suppurative otitis media for Type I tympanoplasty (myringoplasty). INTERVENTIONS: The patients were randomly assigned to 3 groups: Group A underwent 10-minute daily treatments with eardrops for 2 weeks before surgery, Group B underwent 3-minute daily treatments for 2 weeks before surgery, and Group C underwent no treatment. MAIN OUTCOME MEASURES: Preoperative and perioperative bacteriology and success of the surgery as defined by an intact tympanic membrane in the eighth week postsurgery. RESULTS: There were 101 patients entered in the study. The preoperative, perioperative, and postoperative observation of discharge and quantity of the discharge were compared, and no differences were found among the groups (Kruskal-Wallis test). The perioperative culture results were analyzed and 18/21 (86%) became culture negative in Group A, 23/27 (85%) became culture negative in Group B, and 3/21 (14%) became culture negative in the control group (Group C versus Group A or Group B, chi(2) tests p < 0.001). The success rates of surgery as defined by an intact tympanic membrane showed no difference: 28/33 (85%), 27/33 (82%), and 31/35 (89%) in Groups A, B, and C, respectively. The preoperative positive bacteriology rate in the surgical failures was 10/15 (67%), compared with 16/76 (21%) for the successful procedures (p < 0.001). CONCLUSION: Our study has shown that ofloxacin successfully eradicates most bacterial flora preoperatively. We cannot, however, confirm the benefits of its preoperative usage in improving the graft success rate.
RCT Entities:
OBJECTIVE: To establish the efficacy of immediate preoperative ototopical ofloxacin eardrops in eradicating middle ear pathogens and improving operative outcome. STUDY DESIGN: Single-blind, randomized control study. SETTING: Tertiary referral center, ambulatory clinic, and hospital setting. PATIENTS: Consecutive patients with chronic suppurative otitis media for Type I tympanoplasty (myringoplasty). INTERVENTIONS: The patients were randomly assigned to 3 groups: Group A underwent 10-minute daily treatments with eardrops for 2 weeks before surgery, Group B underwent 3-minute daily treatments for 2 weeks before surgery, and Group C underwent no treatment. MAIN OUTCOME MEASURES: Preoperative and perioperative bacteriology and success of the surgery as defined by an intact tympanic membrane in the eighth week postsurgery. RESULTS: There were 101 patients entered in the study. The preoperative, perioperative, and postoperative observation of discharge and quantity of the discharge were compared, and no differences were found among the groups (Kruskal-Wallis test). The perioperative culture results were analyzed and 18/21 (86%) became culture negative in Group A, 23/27 (85%) became culture negative in Group B, and 3/21 (14%) became culture negative in the control group (Group C versus Group A or Group B, chi(2) tests p < 0.001). The success rates of surgery as defined by an intact tympanic membrane showed no difference: 28/33 (85%), 27/33 (82%), and 31/35 (89%) in Groups A, B, and C, respectively. The preoperative positive bacteriology rate in the surgical failures was 10/15 (67%), compared with 16/76 (21%) for the successful procedures (p < 0.001). CONCLUSION: Our study has shown that ofloxacin successfully eradicates most bacterial flora preoperatively. We cannot, however, confirm the benefits of its preoperative usage in improving the graft success rate.