None listed
Conditions
Brief summary
Protocol: Randomized trial of doxycycline and Microdacyn versus standard care for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion procedures Trial sites: Nelson Hospital, and Manuka St Hospital, Nelson 7010 Laboratory: Medlab South, Nelson Hospital, Background :This trial investigates the effect of pre-operative doxycycline or Microdacyn on intra-operative wound contamination. Objectives of the trial To compare the efficacy of additional doxycycline or Microdacyn with standard practices for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion surgery. Trial design: A randomized, unblinded, three-armed, parallel trial of efficacy, including 100 to 200 patients. This trial is designed to be run according to the quality standards of Good Clinical Practice and the Declaration of Helsinki for human trials. Primary endpoint 1. Bacterial contamination of intra-operative wound swabs. Secondary endpoints 1. Post-operative wound infection. 2. Treatment-emergent adverse events (TEAE). Hypothesis: Prophylactic treatment with topical or oral antimicrobials reduces contamination and colonisation of surgical fields
Interventions
To compare the efficacy of additional doxycycline or Microdacyn gel with standard practices for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion surgery. Patients will be randomly allocated to either the Doxycycline, microdacyn or control arms.
Doxycycline arm will receive 100mg orally twice daily for the two days before surgery and one dose on the morning of surgery.
Microdacyn arm will apply 20-40mls of Micodacyn gel to the surgical site fou
To compare the efficacy of additional doxycycline or Microdacyn gel with standard practices for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion surgery. Patients will be randomly allocated to either the Doxycycline, microdacyn or control arms. Doxycycline arm will receive 100mg orally twice daily for the two days before surgery and one dose on the morning of surgery. Microdacyn arm will apply 20-40mls of Micodacyn gel to the surgical site four times a day for the two days before surgery and two doses on the morning of surgery. Compliance of the regime will be monitored by the research assistant asking the patients about compliance and reactions etc
Sponsors
Mr Philip Knight, Orthopaedic Surgeon,
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed