Surgical Wound Infection Clinical Trial
— POTOOfficial title:
Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study
Verified date | September 2017 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 3, 2018 |
Est. primary completion date | September 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - History of neck irradiation or surgery - History of drug allergies - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jin Wook Yi | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Anuwong A, Ketwong K, Jitpratoom P, Sasanakietkul T, Duh QY. Safety and Outcomes of the Transoral Endoscopic Thyroidectomy Vestibular Approach. JAMA Surg. 2017 Sep 6. doi: 10.1001/jamasurg.2017.3366. [Epub ahead of print] — View Citation
Anuwong 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | "CDC 1992 SSI table" score | Clinical evidence of Surgical Site Infection | Postoperative 1 day | |
Primary | CBC, CRP | Laboratory test | Postoperative 1 day | |
Secondary | Change of "CDC 1992 SSI table" score | Clinical evidence of Surgical Site Infection | Compare the CDC 1992 SSI table score between postoperative 1 day and 2 day/2 weeks. | |
Secondary | Change of CBC, CRP | Laboratory test | Compare the CBC, CRP between postoperative 1 day and 2 day |
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