Z Lou2, Z Lou2, Y Tang3, J Xiao4. 1. Department of Otorhinolaryngology, The Affiliated YiWu Hospital of Wenzhou Medical University, Yiwu, Zhejiang, China. louzhengcai@163.com. 2. Department of Clinical Medicine, Xinxiang Medical University, Xinxiang, Henan, China. 3. Department of Pathology, The Affiliated YiWu Hospital of Wenzhou Medical University, Yiwu, Zhejiang, China. 4. Molecular Pharmacology Research Center, School of Pharmacy, Zhejiang Provincial Key Laboratory of Biotechnology Pharmaceutical Engineering, Wenzhou Medical University, Wenzhou, Zhejiang, China.
Abstract
OBJECTIVE: To investigate the effects of direct application of ofloxacin otic drops on human traumatic tympanic membrane perforations (TMPs). STUDY DESIGN: Prospective, sequential allocation, controlled clinical study. SETTING:Tertiary university hospital. PARTICIPANTS: In total, 149 patients with traumatic TMPs were recruited. They were allocated sequentially to two groups: a conservative observation group (n = 75) and a ofloxacin drops-treated group (n = 74). MAIN OUTCOME MEASURES: The closure rate, closure time and rate of otorrhoea were compared between the groups at 6 months. RESULTS: In total, 145 patients were analysed. The closure rates of medium perforations between the groups were not significantly different (P = 0.35); however, the ofloxacin drops-treated group had a significantly shorter closure time for medium perforations than the observation group (P < 0.01). Additionally, the ofloxacin drops-treated group showed improvement in the closure rate of large perforations (P = 0.02) and a significantly shorter mean closure time (P < 0.01) than the observation group. However, purulent otorrhoea was not significantly different between the groups (P = 0.37). CONCLUSIONS: The present findings indicate that the moist eardrum environment resulting from topical application of ofloxacin drops shortened the closure time and improved the closure rate, but did not affect hearing improvement or increase the rate of middle ear infection of large traumatic TMPs. Thus, although traumatic TMPs tend to heal spontaneously, moist therapy can be considered for traumatic, large TMPs in the clinic.
RCT Entities:
OBJECTIVE: To investigate the effects of direct application of ofloxacin otic drops on humantraumatic tympanic membrane perforations (TMPs). STUDY DESIGN: Prospective, sequential allocation, controlled clinical study. SETTING: Tertiary university hospital. PARTICIPANTS: In total, 149 patients with traumatic TMPs were recruited. They were allocated sequentially to two groups: a conservative observation group (n = 75) and a ofloxacin drops-treated group (n = 74). MAIN OUTCOME MEASURES: The closure rate, closure time and rate of otorrhoea were compared between the groups at 6 months. RESULTS: In total, 145 patients were analysed. The closure rates of medium perforations between the groups were not significantly different (P = 0.35); however, the ofloxacin drops-treated group had a significantly shorter closure time for medium perforations than the observation group (P < 0.01). Additionally, the ofloxacin drops-treated group showed improvement in the closure rate of large perforations (P = 0.02) and a significantly shorter mean closure time (P < 0.01) than the observation group. However, purulent otorrhoea was not significantly different between the groups (P = 0.37). CONCLUSIONS: The present findings indicate that the moist eardrum environment resulting from topical application of ofloxacin drops shortened the closure time and improved the closure rate, but did not affect hearing improvement or increase the rate of middle ear infection of large traumatic TMPs. Thus, although traumatic TMPs tend to heal spontaneously, moist therapy can be considered for traumatic, large TMPs in the clinic.