Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT01805856
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2013-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
Sponsor:
Ito Hospital
Organization:
Study Overview
Official Title:
Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ito-RCT1
Brief Summary:
The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.
Detailed Description:
Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP.
Exclusion criteria
* Patients who did not agree to attend the randomized control study.
* Patients who received the operation including mediastinum with sternotomy.
* Patients who received the operation including additional resection of trachea, esophagus and larynx.
* Patients who received the re-operation for post-operative bleedings.
* Patients who had known allergy to cephem or penicillin.
Exclusion criteria
* Patients who did not agree to attend the randomized control study.
* Patients who received the operation including mediastinum with sternotomy.
* Patients who received the operation including additional resection of trachea, esophagus and larynx.
* Patients who received the re-operation for post-operative bleedings.
* Patients who had known allergy to cephem or penicillin.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: