Randomized trial of doxycycline and Microdacyn versus standard care for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion procedures

Completed

• Conditions: Intraoperative wound contamination; postoperative infection; Infection - Other infectious diseases; Surgery - Other surgery

• Registration Number: ACTRN12615001233516
• Lead Sponsor: Mr Philip Knight, Orthopaedic Surgeon,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Able to provide informed consent; willingness to take part.
To undergo a clean procedure in Orthopaedic (e.g. joint prosthesis, arthroscopy, tendon repair, internal fixation, laminectomy, spinal fusion) or pacemaker insertion surgery
During the period 9 November 2015 to 10 February 2016 (for shoulder procedures at Manuka St Hospital during the extended period of 9 November 2015 to 9 November 2016).

Exclusion Criteria

Pregnancy or breastfeeding.
Past adverse reaction to Microdacyn, doxycycline, minicycline tetracycline, cephlasporins , severe penecillin reactions, or chloxhexadine.
Previous Clostridium difficile colitis.
Suspected current 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.
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 three study groups. [2x Swabs taken at start and end of operation]