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

Phase 3

Completed

• Conditions: Surgical site infection; Infection - Studies of infection and infectious agents; Surgery - Other surgery

• Registration Number: ACTRN12615000021572
• Lead Sponsor: John Hunter Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• Study Completion: 2019-03-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3301

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The surgical site infection rate as determined by the objective and subjective parameters defined by the Center for Disease Control (CDC) USA criteria for SSI 2015.[All patients will be reviewed at day 30 post-operatively for superficial surgical site infection. ]

Secondary Outcome Measures

Name	Time	Method
Total surgical complication rate (Clavien Dindo score)[Day 30 for superficial SSI for all participants with surveillance to 90 days for deep organ/space SSI for a subgroup of patients.];Length of Hospital Stay as assessed from medical record admission and discharge dates.[Date of discharge from surgical services.];Readmission rate, as assessed by number of patients readmitted to hospital for management of a post-operative surgical site infection.[Day 30 for superficial SSI for all participants with surveillance to 90 days for deep organ/space SSI for a subgroup of patients.];Hypersensitivity reaction rate assessed by observation by nursing and/or medical staff for skin irritation, redness, swelling within 24 hours of surgery.[within 24 hours of surgery]