Thyroid DiseaseIto-RCT1NCT01805856
Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
A study testing PIPC piperacillin sodium and CEZ, cefazolin sodium in people with Thyroid Disease and Parathyroid Disease, run by Ito Hospital at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Thyroid Disease, Parathyroid Disease
- What is being tested?
- PIPC piperacillin sodium and CEZ, cefazolin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,164 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2010to May 2012
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
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.
Read the 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.
- Conditions
- Thyroid Disease, Parathyroid Disease
- Being tested
- PIPC piperacillin sodium, CEZ, cefazolin sodium
- Keywords
- antimicrobial prophylaxis, AMP, surgical site infection, SSI, thyroid, thyroidectomy, parathyroid, surgery
- Medical subject headings
- Thyroid Diseases, Parathyroid Diseases, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPC piperacillin sodiumDrug
Also called PIPC, piperacillin sodium
CEZ, cefazolin sodiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A (intervention PIPC) | Experimental | Patients in group A (intervention PIPC) were given AMP of 2g PIPC intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose PIPC was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done. Receives: Drug: PIPC piperacillin sodium |
| Group B (intervention CEZ) | Experimental | Patients in Group B (intervention CEZ) were given AMP of 1g CEZ intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose CEZ was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done. Receives: Drug: CEZ, cefazolin sodium |
| Group C (without AMP) | No intervention | Patients in Group C underwent surgery without any AMP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infections after thyroid and parathyroid surgery
Surgical site infection was defined as patients who are necessary to receive the treatment such as surgical drainage or antibiotic medication. When the patients receive the surgical drainage, microbial culture was performed.
Measured: 1 month after operation
Secondary outcomes (1)
Side effect of the drug for Antimicrobial prophylaxis
The appearances of drug allergic reactions (skin rash and anaphylactic shock) were checked at operating room. Blood test to check up liver and renal dysfunction was done on the 3rd POD. Liver and renal dysfunction is clinically diagnosed by patients' own physicians and the author, and only counted the cases which function got worse compared to preoperative data.
Measured: 4 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startNov 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ito Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Takashi Uruno, MD, Principal investigator, Ito Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805856
- Sponsor's protocol ID
- Ito-RCT1
- Acronym
- Ito-RCT1
- Status last verified
- Mar 2013
- First submitted
- 5 Mar 2013
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
- ClinicalTrials.gov ID
- NCT01805856
- Acronym / sponsor ID
- Ito-RCT1 / Ito-RCT1
- Conditions
- Thyroid Disease, Parathyroid Disease
- Keywords
- antimicrobial prophylaxis, AMP, surgical site infection, SSI, thyroid, thyroidectomy, parathyroid, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,164 participants (actual)
- Lead sponsor
- Ito HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 6 Mar 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (intervention PIPC) | Experimental | Drug: PIPC piperacillin sodiumPatients in group A (intervention PIPC) were given AMP of 2g PIPC intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose PIPC was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done. |
| Group B (intervention CEZ) | Experimental | Drug: CEZ, cefazolin sodiumPatients in Group B (intervention CEZ) were given AMP of 1g CEZ intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose CEZ was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done. |
| Group C (without AMP) | No intervention | –Patients in Group C underwent surgery without any AMP. |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PIPC piperacillin sodiumAlso: PIPC, piperacillin sodium | Drug | Group A (intervention PIPC) |
| CEZ, cefazolin sodium | Drug | Group B (intervention CEZ) |
Primary outcome
Surgical site infections after thyroid and parathyroid surgery
Time frame: 1 month after operation
Surgical site infection was defined as patients who are necessary to receive the treatment such as surgical drainage or antibiotic medication. When the patients receive the surgical drainage, microbial culture was performed.
1 secondary outcome
Side effect of the drug for Antimicrobial prophylaxis
Time frame: 4 days after operation
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 6 Mar 2013.
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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.
Takashi Uruno, MD principal investigator
Ito Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIPC piperacillin sodium and CEZ, cefazolin sodium in people with Thyroid Disease and Parathyroid Disease, run by Ito Hospital at 1 site in Japan.
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 1 inclusion and 5 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 6 Mar 2013. 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 Japan. 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?
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?
Surgical site infections after thyroid and parathyroid surgery (time frame: 1 month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2013.