NCT03845777

Brief Summary

Objective: The routine use of topical iodinated antiseptic could be a possible cause of iodine contamination. The aim of this study is to evaluate iodine concentrations in operation-room staff who routinely use iodine-containing antiseptics for cleansing of the hands after salt iodization. Methods: The study included 40 surgeons and surgical nurses who use surgical hand-scrub solutions. Participants applied an iodized brush for a minimum of three times a day on weekdays and were iodine-free on the weekends. Morning spot urine specimens were collected from all participants to analyze the urinary iodine concentration (UIC) twice a week.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 16, 2019

Last Update Submit

February 18, 2019

Conditions

Keywords

IodineSurgicalStaffAntiseptic

Outcome Measures

Primary Outcomes (1)

  • Urine Iodine

    The subjects used iodine-containing hand scrub solutions on weekdays and were iodine-free on the weekends. Early-morning spot urine specimens were collected from all participants to analyze the UIC twice a week: once at the beginning of the working period (the washout period of the antiseptic) and once at the end of the working period (the antiseptic exposure period).

    1 week

Study Arms (1)

Surgical Staff

The surgical staff group is the only group of the study. Blood samples of the surgical staff before and after the using antiseptics solution that include iodine were analyzed.

Diagnostic Test: Using Antiseptic solution

Interventions

Using of iodine including antiseptic solutions. The investigators investigate the urine iodine status of staff before and after the using of antiseptic solution

Surgical Staff

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The surgical staff used iodine-containing hand scrub solutions for antisepsis

You may qualify if:

  • Surgical staff

You may not qualify if:

  • goiter
  • hypertension
  • thyroidectomy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, 34452, Turkey (Türkiye)

Location

Related Publications (3)

  • Erdogan MF, Tatar FA, Unluturk U, Cin N, Uysal AR. The effect of scrubbing hands with iodine-containing solutions on urinary iodine concentrations of the operating room staff. Thyroid. 2013 Mar;23(3):342-5. doi: 10.1089/thy.2012.0325.

  • Grasso L, Maxia PL, Bartalena L, Murtas ML, Taberlet A, Martino E. Iodine contamination in subjects admitted to a general hospital. J Endocrinol Invest. 1992 Apr;15(4):307-8. doi: 10.1007/BF03348739.

  • Michalaki M, Pylioti A, Loutas V, Mamali I, Markou KB. Absence of differences in urinary iodine excretion and thyroid function tests in operating room staff members using or not using iodine-containing antiseptic solutions. Thyroid. 2013 Dec;23(12):1659-60. doi: 10.1089/thy.2013.0218. Epub 2013 Aug 1. No abstract available.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Sema Yarman, Prof.

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

February 16, 2019

First Posted

February 19, 2019

Study Start

November 1, 2017

Primary Completion

February 28, 2018

Study Completion

November 30, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations