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Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children

Primary Purpose

Post Operative Wound Infection, Graft Uptake, Myringoplasty

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Co-amoxiclav
Sponsored by
Tribhuvan University, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Wound Infection

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age : patients between 6 to 15 years of age
  • Gender : both male and female patients
  • Disease: Chronic otitis media mucosal inactive (dry for at least 4 weeks)

Exclusion Criteria:

  • Actively discharging ear pre-operatively
  • Revision myringoplasty
  • Allergic to co-amoxiclav

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Antibiotics group

    No antibiotics group

    Arm Description

    Patients in this group will receive single dose of intravenous co-amoxiclav (Dose: 25 mg/kg body weight) which will be injected 30 minutes prior to the incision during surgery.

    Patients belonging to this group will not receive any systemic antibiotic during intraoperative or post-operative period.

    Outcomes

    Primary Outcome Measures

    : Number of Participants with postoperative wound infection
    Number of participants who have had at least one episode of infection in the postoperative period. postoperative infection : Infection occurring within 4 weeks of postoperative periods Postoperative infection : Presence of any of the following findings on clinical examination Wound gaping Purulent discharge from incision site Purulent discharge from external auditory canal Measurement tool used to assess the measure Clinical examination of patient by examiner Wound assessment : Examination of pinna , incision site and graft donor site Any signs of infections if present will be noted in performa.

    Secondary Outcome Measures

    Number of Participants with successful graft uptake
    Number of participants who have had successful graft uptake at the end of 3 months of postoperative period Successful graft uptake: complete healing of tympanic membrane and graft is intact. Graft uptake failure : perforation of any size Measurement tool used to assess the measure otoscopic examination of the operated ear Successful Graft uptake or failure is noted on performa.

    Full Information

    First Posted
    September 29, 2018
    Last Updated
    October 8, 2018
    Sponsor
    Tribhuvan University, Nepal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03700814
    Brief Title
    Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children
    Official Title
    Comparison of Postoperative Infection and Graft Uptake Rate Using Single Dose of Intravenous Co-amoxiclav Versus no Antibiotic in Children Undergoing Myringoplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2014 (Actual)
    Primary Completion Date
    June 6, 2015 (Actual)
    Study Completion Date
    September 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tribhuvan University, Nepal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Wound Infection, Graft Uptake, Myringoplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antibiotics group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive single dose of intravenous co-amoxiclav (Dose: 25 mg/kg body weight) which will be injected 30 minutes prior to the incision during surgery.
    Arm Title
    No antibiotics group
    Arm Type
    No Intervention
    Arm Description
    Patients belonging to this group will not receive any systemic antibiotic during intraoperative or post-operative period.
    Intervention Type
    Drug
    Intervention Name(s)
    Co-amoxiclav
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    : Number of Participants with postoperative wound infection
    Description
    Number of participants who have had at least one episode of infection in the postoperative period. postoperative infection : Infection occurring within 4 weeks of postoperative periods Postoperative infection : Presence of any of the following findings on clinical examination Wound gaping Purulent discharge from incision site Purulent discharge from external auditory canal Measurement tool used to assess the measure Clinical examination of patient by examiner Wound assessment : Examination of pinna , incision site and graft donor site Any signs of infections if present will be noted in performa.
    Time Frame
    At Visit 1, [Post-op Day 1 ], at Visit 2 [Post-op Day 3] ,at Visit 3 [Day 8 to Day 14] ], at Visit 4 [ Day 28 to day 30]
    Secondary Outcome Measure Information:
    Title
    Number of Participants with successful graft uptake
    Description
    Number of participants who have had successful graft uptake at the end of 3 months of postoperative period Successful graft uptake: complete healing of tympanic membrane and graft is intact. Graft uptake failure : perforation of any size Measurement tool used to assess the measure otoscopic examination of the operated ear Successful Graft uptake or failure is noted on performa.
    Time Frame
    At Visit 4 [ Day 28 to day 30], at Visit 5 [ day 80 to day 90]

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age : patients between 6 to 15 years of age Gender : both male and female patients Disease: Chronic otitis media mucosal inactive (dry for at least 4 weeks) Exclusion Criteria: Actively discharging ear pre-operatively Revision myringoplasty Allergic to co-amoxiclav
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prakash Khanal, MS,ENT
    Organizational Affiliation
    Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31981921
    Citation
    Khanal P, Guragain RP, Bhusal CL. Comparison of postoperative infection and graft uptake rate using single dose of intravenous co-amoxiclav versus no antibiotic in children undergoing myringoplasty: A randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2020 Apr;131:109893. doi: 10.1016/j.ijporl.2020.109893. Epub 2020 Jan 18.
    Results Reference
    derived

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    Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children

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