Surgical Wound InfectionPOTONCT03295955
Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy
A study testing Amoxicillin Clavulanate in people with Surgical Wound Infection and Thyroid Nodule, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Surgical Wound Infection, Thyroid Nodule
- What is being tested?
- Amoxicillin Clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Sep 2017to 3 Dec 2018
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who planned to Transoral endoscopic thyroidectomy
- Age between 20 to 70
- Voluntarily consenting to the study and study agreement
- No local invasion or distant metastasis
- Normal vocal cord function in laryngoscopic exam
- No significant abnormalities in preoperative laboratory tests
Who cannot join
- Take aspirin or antiplatelet drugs within 7 days before admission
- Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Substance abuse and alcohol abuse
- History of esophageal and airway diseases
- Patient was participated in other clinical trials within 30 days
Show all 9Show fewer
- History of neck irradiation or surgery
- History of drug allergies
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jin Wook Yi
Seoul, 03080
Jin Wook Yi, MD, MS, +82-2-2072-3243, gnsljw@gmail.com
About this study
Official title: Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.
Read the detailed description
To prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. The investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.
- Conditions
- Surgical Wound Infection, Thyroid Nodule
- Being tested
- Amoxicillin Clavulanate
- Medical subject headings
- Surgical Wound Infection, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin ClavulanateDrug
Per-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery
| Study group | Role | What they receive |
|---|---|---|
| Postop antibiotics group | Active comparator | Prescribe Amoxicillin Clavulanate Receives: Drug: Amoxicillin Clavulanate |
| No postop antibiotics | No intervention | Do not prescribe Amoxicillin Clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
"CDC 1992 SSI table" score
Clinical evidence of Surgical Site Infection
Measured: Postoperative 1 day
CBC, CRP
Laboratory test
Measured: Postoperative 1 day
Secondary outcomes (2)
Change of "CDC 1992 SSI table" score
Clinical evidence of Surgical Site Infection
Measured: Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
Change of CBC, CRP
Laboratory test
Measured: Compare the CBC, CRP between postoperative 1 day and 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start4 Sep 2017
- Primary completion3 Sep 2018 (estimated)
- Study completion3 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wook Yi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295955
- Sponsor's protocol ID
- 1708-028-875
- Acronym
- POTO
- Status last verified
- Sep 2017
- First submitted
- 20 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.
PubMed 28877292Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
PubMed 26546193Yi JW, Kim SJ, Lee KE. Evaluation of the efficacy of postoperative antibiotic treatment in transoral endoscopic thyroidectomy: a prospective randomised controlled trial. Br J Oral Maxillofac Surg. 2020 Apr;58(3):334-340. doi: 10.1016/j.bjoms.2020.01.004. Epub 2020 Jan 22.
PubMed 31982170
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT03295955
- Acronym / sponsor ID
- POTO / 1708-028-875
- Conditions
- Surgical Wound Infection, Thyroid Nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 3 Sep 2018 (estimated)
- Study completion
- 3 Dec 2018 (estimated)
- First posted
- 28 Sep 2017 (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.
Transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. This study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.
Detailed description
To prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. Currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. The investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postop antibiotics group | Active comparator | Drug: Amoxicillin ClavulanatePrescribe Amoxicillin Clavulanate |
| No postop antibiotics | No intervention | –Do not prescribe Amoxicillin Clavulanate |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who planned to Transoral endoscopic thyroidectomy
- Age between 20 to 70
- Voluntarily consenting to the study and study agreement
- No local invasion or distant metastasis
- Normal vocal cord function in laryngoscopic exam
Key exclusion criteria (9 listed)
- Take aspirin or antiplatelet drugs within 7 days before admission
- Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Substance abuse and alcohol abuse
- History of esophageal and airway diseases
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 |
|---|---|---|
| Amoxicillin ClavulanatePer-oral "Amoxicillin Clavulanate" Given or Non-given, after surgery | Drug | Postop antibiotics group |
Primary outcome
"CDC 1992 SSI table" score
Time frame: Postoperative 1 day
Clinical evidence of Surgical Site Infection
CBC, CRP
Time frame: Postoperative 1 day
Laboratory test
2 secondary outcomes
Change of "CDC 1992 SSI table" score
Time frame: Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks.
Change of CBC, CRP
Time frame: Compare the CBC, CRP between postoperative 1 day and 2 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Results publication: PubMed 28877292Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2018 Jan 1;153(1):21-27. doi: 10.1001/jamasurg.2017.3366.
- Results publication: PubMed 26546193Anuwong A. Transoral Endoscopic Thyroidectomy Vestibular Approach: A Series of the First 60 Human Cases. World J Surg. 2016 Mar;40(3):491-7. doi: 10.1007/s00268-015-3320-1.
- Derived from this study: PubMed 31982170Yi JW, Kim SJ, Lee KE. Evaluation of the efficacy of postoperative antibiotic treatment in transoral endoscopic thyroidectomy: a prospective randomised controlled trial. Br J Oral Maxillofac Surg. 2020 Apr;58(3):334-340. doi: 10.1016/j.bjoms.2020.01.004. Epub 2020 Jan 22.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin Clavulanate in people with Surgical Wound Infection and Thyroid Nodule, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"CDC 1992 SSI table" score (time frame: Postoperative 1 day). The study lists 2 primary outcomes in all. 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 NCT03295955, which also lists 3 linked publications.
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 28 Sep 2017.