Post Operative Wound InfectionPhase 4NCT03700814
Does Antibiotics Use During Surgery Help to Decrease Wound Infection and Increase Success After Ear Surgery in Children
A Phase 4 study testing Co-amoxiclav in people with Post Operative Wound Infection and Graft Uptake, run by Tribhuvan University, Nepal.
Trial summary
This study assess whether there is any role of antibiotics to decrease wound infection and increase the success of surgery Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Post Operative Wound Infection, Graft Uptake, Myringoplasty
- What is being tested?
- Co-amoxiclav
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2014to 1 Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Actively discharging ear pre-operatively
- Revision myringoplasty
- Allergic to co-amoxiclav
About this study
Official title: Comparison of Postoperative Infection and Graft Uptake Rate Using Single Dose of Intravenous Co-amoxiclav Versus no Antibiotic in Children Undergoing Myringoplasty
This study assess whether there is any role of antibiotics to decrease wound infection and increase the success of surgery
Read the 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.
- Conditions
- Post Operative Wound Infection, Graft Uptake, Myringoplasty
- Being tested
- Co-amoxiclav
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-amoxiclavDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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.
Measured: 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
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.
Measured: At Visit 4 [ Day 28 to day 30], at Visit 5 [ day 80 to day 90]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Jan 2014
- Primary completion6 Jun 2015
- Study completion1 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prakash Khanal, Tribhuvan University, Nepal
- Investigators
- Prakash Khanal, MS,ENT, Principal investigator, Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700814
- Sponsor's protocol ID
- 121
- Status last verified
- Oct 2018
- First submitted
- 29 Sep 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31981921
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Infection and Graft Uptake Rate Using Single Dose of Intravenous Co-amoxiclav Versus no Antibiotic in Children Undergoing Myringoplasty
- ClinicalTrials.gov ID
- NCT03700814
- Acronym / sponsor ID
- 121
- Conditions
- Post Operative Wound Infection, Graft Uptake, Myringoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 10 Jan 2014 (actual)
- Primary completion
- 6 Jun 2015 (actual)
- Study completion
- 1 Sep 2015 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotics group | Experimental | Drug: Co-amoxiclavPatients 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. |
| No antibiotics group | No intervention | –Patients belonging to this group will not receive any systemic antibiotic during intraoperative or post-operative period. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Actively discharging ear pre-operatively
- Revision myringoplasty
- Allergic to co-amoxiclav
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-amoxiclavPatients 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. | Drug | Antibiotics group |
Primary outcome
: Number of Participants with postoperative wound infection
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]
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.
1 secondary outcome
Number of Participants with successful graft uptake
Time frame: At Visit 4 [ Day 28 to day 30], at Visit 5 [ day 80 to day 90]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Derived from this study: PubMed 31981921Khanal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prakash Khanal, MS,ENT principal investigator
Ganesh Man Singh Memorial Academy (GMSMA) of ENT-Head and Neck Studies, TU Teaching Hospital, Institute of Medicine (IOM)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Co-amoxiclav in people with Post Operative Wound Infection and Graft Uptake, run by Tribhuvan University, Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Number of Participants with postoperative wound infection (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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03700814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.