Comparison of Postoperative Infection and Graft Uptake Rate Using Single Dose of Intravenous Co-amoxiclav Versus no Antibiotic in Children Undergoing Myringoplasty

Chronic Otitis Media is the disease of middle part of the ear. It presents with intermittent ear discharge and hearing loss of various severity. It is one of the commonest ear disease. This problem is treated with surgical procedure known as Myringoplasty. This surgical technique that involves repair of the tympanic membrane perforation. Myringoplasty is a clean type of surgery. Wound infection following this surgery is very low that is about less than 2 persons out of 100 people. So antibiotics is not necessary in this surgery. However antibiotics have been used unnecessarily. Unnecessary use of antibiotic increases financial burden to the patient and also leds to the development of drug resistant microorganisms.

The aims of this study is to evaluate the effectiveness and safety of antibiotics to decrease wound infection and increase the success of surgery. This will be a prospective, randomized, single-center, double-blinded, placebo controlled study. This study will be carried out over a period of 18 months from January 2014 to June 2015. The study will be carried out at Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, Tribhuvan University Teaching Hospital, Maharajgunj Medical Campus (MMC), Institute of Medicine (IOM), Kathmandu, Nepal.

Patient who are diagnosed to have chronic otitis media mucosal, inactive type who present in GMSMA of ENT- Head and Neck Studies outdoor clinic for surgery will be included for the study. Age of the patient included will be between six to 15 years of age. Both male and female patients can participate in this study. Patient who are having actively discharging ear cannot participate in the study. Similarly patients who are undergoing surgery for second times will not be qualified for study. Also patients who are allergic to co-amoxiclav will not be qualified for the study.

Total of sixty patients will participate in this study. The patients coming to our OPD will be first screened by the faculties Detail history, general physical examination, ENT - Head and Neck examination with Otoscopic examination and Tuning fork test will be done. Hearing assessment will be done. All patients will be admitted in ward day prior to surgery and pre-anaesthetic evaluation will be carried out by anaesthesiologist regarding their fitness for surgery under general anaesthesia.

Patients will be randomly divided in to two groups by lottery methods. However patient will not know about which group they belong. Patients in the first group will receive single dose of antibiotics which will be injected during surgery .Patients belonging to this group will not receive any antibiotics during surgery. All surgeries will be carried out under general anaesthesia by experienced faculty. Temporalis fascia will be used to close the perforation of ear drum. Gelfoam soaked in ciprofloxacin (0.3%) ear drops will be placed over the graft. Then ribbon gauze impregnated with Bismuth Iodoform Paraffin Paste (BIPP) was packed in external auditory canal above gelfoam. Skin incisions will be sutured in layers with 4-0 Vicryl and skin with 4-0 Ethilon. Mastoid bandage will be then applied.