A randomised study comparing alcohol-based povidone iodine and chlorhexidine-alcohol as a skin preparation in preventing surgical site infections

Alcohol-based povidone iodine versus chlorhexidine-alcohol in the prevention of surgical site infection: A prospective comparative study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000333-23-IE

Enrollment

400

Registered

2015-08-13

Start date

2015-10-02

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

Interventions

Trade Name: Videne Alcohol Tincture Pharmaceutical Form: Cutaneous solution Trade Name: Chloraprep 2% w/v 70% v/v cutaneous solution Pharmaceutical Form: Cutaneous solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients that are schedules for a vertical midline laparotomy 2. Aged 18 and over 3. Patients who have the capacity to consent to the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: 1. Patients who have a documented allergy or sensitivity to Chloraprep or Videne Alcoholic Tincture 2. Patients who are unable to consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The study seeks to test the hypothesis that a single centred randomised trial comparing two skin preparation agents (chloraprep and Videne Alcoholic Tincture will show a significant effect on SSI rates on the basis of which skin preparation was used;Secondary Objective: To collect and collate data to ascertain departmental surgical site infarction incidence in patients undergoing midline emergency and elective laparotomy for general surgical procedures;Primary end point(s): The end point to the study will be when the total number of participants is reached, 400 participants. ;Timepoint(s) of evaluation of this end point: It is expected that this endpoint will be reached in 2 years. This has been calculated by using the number of eligible patients per year and the total number of participants needed for the study. 200 patients per year for 2 years will reach the target number of participants which is 400.	—

Measure

Time frame

Main Objective: The study seeks to test the hypothesis that a single centred randomised trial comparing two skin preparation agents (chloraprep and Videne Alcoholic Tincture will show a significant effect on SSI rates on the basis of which skin preparation was used;Secondary Objective: To collect and collate data to ascertain departmental surgical site infarction incidence in patients undergoing midline emergency and elective laparotomy for general surgical procedures;Primary end point(s): The end point to the study will be when the total number of participants is reached, 400 participants. ;Timepoint(s) of evaluation of this end point: It is expected that this endpoint will be reached in 2 years. This has been calculated by using the number of eligible patients per year and the total number of participants needed for the study. 200 patients per year for 2 years will reach the target number of participants which is 400.

—

Secondary

Measure	Time frame
Secondary end point(s): A secondary end point will be if there is new information on either preparation that would indicate that the study should be changed or discontinued. ;Timepoint(s) of evaluation of this end point: The endpoint will be evaluated on a monthly basis at the surgical research meeting in RCSI and analysis will be conducted at these points.	—

Countries

Ireland

Contacts

Public ContactTrudi Roche

Beaumont Hospital

troche@rcsi.ie353868194827

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026