OBJECTIVE: To retrospectively study the clinical effects of eardrum flap area on the healing outcome following traumatic perforation. METHODS:Totally 291 traumatic eardrum perforations with in-/everted edges were included in this study. They were randomly divided into three groups and received conservative treatment, epidermal growth factor (EGF) via Gelfoam patching, or edge-approximation plus Gelfoam patching respectively. Patients in each group were further divided into two subgroups according to the eardrum flap area less than or equal to 1/2 or >1/2 of the perforation size. The healing rate and mean closure time after tympanic membrane perforation were evaluated at three months. RESULTS:Of the total 291 participants, 281 were included in the final statistical analysis. The area of curled edge did not affect the healing outcome significantly in any groups (P>0.05). The healing rate varied slightly: 90.7% vs 92.3% in spontaneous healing group, 98.2% vs 97.4% in EGF via Gelfoam patching group, and 96.5% vs 100% in edge-approximation plus Gelfoam patching group. In addition, in all groups the area of curled edge did not affect the mean closure time significantly (P>0.05). The closure time was (32.3+/-2.4) d vs (30.6+/-3.1) d in sponaneous healing group, (13.4+/-2.5) d vs (13.1+/-1.9) d in EGF via Gelfoam patching group, and (11.9+/-3.1) d vs (12.2+/-2.1) d in edge-approximation plus Gelfoam patching group. CONCLUSION: The eardrum flap area of traumatic eardrum perforation does not significantly affect the clinical outcomes.
RCT Entities:
OBJECTIVE: To retrospectively study the clinical effects of eardrum flap area on the healing outcome following traumatic perforation. METHODS: Totally 291 traumatic eardrum perforations with in-/everted edges were included in this study. They were randomly divided into three groups and received conservative treatment, epidermal growth factor (EGF) via Gelfoam patching, or edge-approximation plus Gelfoam patching respectively. Patients in each group were further divided into two subgroups according to the eardrum flap area less than or equal to 1/2 or >1/2 of the perforation size. The healing rate and mean closure time after tympanic membrane perforation were evaluated at three months. RESULTS: Of the total 291 participants, 281 were included in the final statistical analysis. The area of curled edge did not affect the healing outcome significantly in any groups (P>0.05). The healing rate varied slightly: 90.7% vs 92.3% in spontaneous healing group, 98.2% vs 97.4% in EGF via Gelfoam patching group, and 96.5% vs 100% in edge-approximation plus Gelfoam patching group. In addition, in all groups the area of curled edge did not affect the mean closure time significantly (P>0.05). The closure time was (32.3+/-2.4) d vs (30.6+/-3.1) d in sponaneous healing group, (13.4+/-2.5) d vs (13.1+/-1.9) d in EGF via Gelfoam patching group, and (11.9+/-3.1) d vs (12.2+/-2.1) d in edge-approximation plus Gelfoam patching group. CONCLUSION: The eardrum flap area of traumatic eardrum perforation does not significantly affect the clinical outcomes.