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Effect of surgical skin preparations on post-operative skin infections in patients having surgical procedures

A Randomised Clinical Trial in Participants Undergoing Incisional Surgery, to Assess the Efficacy of Surgical Skin Preparation: A Three-armed Comparison of Chlorhexidine versus Povidone-iodine Preparations

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000021572
Enrollment
3301
Registered
2015-01-15
Start date
2015-07-07
Completion date
2018-09-19
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Surgical site infections are one of the most common infections that a person may acquire in hospital, and can increase the length of stay and the cost of the surgery by up to 5 times. This is a burden on the person and the community. By preventing infections in surgical sites it is hoped that a person’s health will be better after an operation. With any surgical procedure, the skin at the operation site is routinely cleansed with an antiseptic solution. This skin cleansing solution aims to reduce the number of germs (microorganisms) present on the skin and therefore reduce the chance of the surgical wound becoming infected. It is not known whether one skin antiseptic is better than the other at preventing infection, so the Research Team would like to see if there is a difference between 3 commonly used, approved skin disinfectants. The solutions are used world-wide for disinfecting the skin in surgical procedures.

Interventions

2% Chlorhexidine + 70% alcohol 10% Povidone-iodine + 70% alcohol 10% Aqueous Povidone-iodine

Sponsors

John Hunter Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective or semi-urgent incisional surgery requiring skin preparation, that have provided written informed consent and are aged 18 years and over.

Exclusion criteria

Patients will be excluded if they: -Refuse or are unable to give written informed consent to participate in the study, or -are under 18 years of age, or -have a history of allergy to iodophors -have a current infection at, or adjacent to the operative site -have current evidence of generalised sepsis -screen positive for MRO (Multi Resistant Organism) -unable to attend routine follow-up appointments -previous participation in this study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026