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

NCT03700814 | Completed Phase 4

• 1 other identifier: 121
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post Operative Wound Infection; Graft Uptake; Myringoplasty

Outcome Measures

Primary Outcomes (1)

• : 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 1. Wound gaping 2. Purulent discharge from incision site 3. 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.

  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 Outcomes (1)

• Number of Participants with successful graft uptake

  At Visit 4 [ Day 28 to day 30], at Visit 5 [ day 80 to day 90]

Study Arms (2)

Antibiotics group

EXPERIMENTAL

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.

Drug: Co-amoxiclav

No antibiotics group

NO INTERVENTION

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

Interventions

Co-amoxiclav DRUG

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.

Antibiotics group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Tribhuvan University, Nepal: lead

Related Publications (1)

• 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.

  PMID: 31981921 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Prakash Khanal, MS,ENT

  Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ENT- Head and Neck Surgeon

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 9, 2018
• Study Start: January 10, 2014
• Primary Completion: June 6, 2015
• Study Completion: September 1, 2015
• Last Updated: October 10, 2018

Record last verified: 2018-10