Randomized trial of pre-operative Microdacyn versus standard care for prevention of intra-operative wound contamination and post-operative infection in clean surgical procedures

Phase 4

• Conditions: Intra-operative wound contamination; Post-operative wound infection; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12616001391460
• Lead Sponsor: Richard Everts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Able to provide informed consent; willingness to take part.
To undergo a clean elective surgical procedure (e.g. joint prosthesis, arthroscopy, tendon repair, internal fixation, laminectomy, spinal fusion, pacemaker insertion, thyroid, breast surgery)

Exclusion Criteria

Pregnancy or breastfeeding.
Past adverse reaction to Microdacyn, a cephalosporin antibiotic or chlorhexidine.
Unable to receive cefazolin as pre-operative intravenous prophylaxis (e.g. previous severe adverse reaction to a penicillin antibiotic).
Suspected current or previous infection on the overlying skin or in the deep tissues at the operation site.
At least one dose of a systemic antibiotic in the 4 days before the start of the trial (other than routine pre-operative prophylaxis).
The operation site is covered by plaster of Paris or a dressing during the 3 days before the operation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the mean number of bacteria isolated from wound swabs in the four study groups.[2x swabs taken at the start of the operation and 2x swabs taken at the end of the operation]

Secondary Outcome Measures

Name	Time	Method
Incidence of post-operative wound infection in the four study groups. The assistants will contact each patient and enquire about symptoms of wound infection. Patients will also be asked to notify the lead investigator if symptoms of wound infection occur. Wound infection will be determined according to formal New Zealand definitions for a post-operative clean wound infection (based on National Healthcare Safety Network (CDC) definitions 2015).[21 to 28 days and 1 year post-operative];Incidence of treatment-emergent adverse events (TEAE, such as skin discomfort, itch or rash) in the four study groups. The assistants will contact each patient and enquire about TEAE. Patients will also be asked to notify the lead investigator or the research assistants if any TEAE occur. [1 to 2 days pre-operatively and 21 to 28 days post-operative]