Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children
Condition: Post Operative Wound Infection; Graft Uptake; Myringoplasty
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assess whether there is any role of antibiotics to decrease wound infection and
      increase the success of surgery
    

Detailed description: 
      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.

      After surgery patient will be shifted to ward, analgesics will be given routinely and on
      demand of the patient. First dressing will be done on first postoperative day, second
      dressing will be done on 3rd postoperative day and 3rd dressing on 6th postoperative days.
      Suture will be removed on sixth postoperative day and ear pack will be removed on tenth
      postoperative day. Any complication will be noted. Antibiotic ear drop Ciprofloxacin 3 drops
      8 hourly will be prescribed for 2 weeks after the removal of pack. Wound Examination will be
      done on 1st, 2nd and 4th week by examining pinna, incision site and ear canal for any signs
      of infections. Graft status was assessed at 3 months for successful graft uptake or residual
      perforation

      Benefit of participation:

      You will have the opportunity to be the first to benefit from a new method under study. You
      will have the chance to play an active role in your own health care and gain a greater
      understanding of your disease or condition. You will help society by contributing to medical
      research. Even if you don't directly benefit from the results of the clinical trial you take
      part in, the information gathered can help others and adds to scientific knowledge. People
      who take part in clinical trials are vital to the process of improving medical care. There
      are no reported side effects of the treatment methods.

      Funding the study:

      The funding of this study will be done by the researcher and the hospital where this study
      will be carried out.

      Privacy:

      Your name will not be published anywhere that data about the trial are published or included
      in any publicly available information.
    

Intervention name(s): Co-amoxiclav
Intervention type(s): Drug
Intervention description(s): Patients in this group will receive single dose of intravenous co-amoxiclav (Dose: 25 mg/kg body weight) which was injected 30 minutes prior to the incision during surgery.
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment