None listed
Conditions
Brief summary
Background: Infections after surgery, especially prosthesis surgery, are uncommon but potentially devastating. The bacteria that cause most of these infections are thought to enter the wound during the operation. Routine peri-operative anti-septic and antibiotic procedures do not eradicate bacteria hiding under the skin surface in hair follicles and sweat glands. These bacteria leak into the wound during the operation. In a randomized, controlled trial 9 months ago (unpublished to date), we found 2 days of pre-operative Microdacyn reduced the quantity of the bacteria that contaminated 'clean' wounds by 80%. We wish to perform this study in a new and larger group of participants undergoing a wider range of surgical procedures and compare different doses and durations of Microdacyn . Protocol: Randomized trial of Microdacyn (3 dose arms) versus standard care for prevention of intraoperative wound contamination in clean surgical procedures Trial sites: Nelson Hospital, and Manuka St Hospital, Nelson 7010 Laboratory: Medlab South, Nelson Hospital, Objectives of the trial To compare the efficacy of additional Microdacyn with standard practices for prevention of intra-operative wound contamination in clean surgery. Trial design: A randomized, unblinded, four-armed, parallel trial of efficacy, including 150 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 Microdacyn reduces contamination of surgical fields; a longer course of treatment will be more effective than a single dose
Interventions
To compare the efficacy of additional Microdacyn with standard practices for prevention of
intra-operative wound contamination in clean surgical procedures. Microdacyn hydrogel (Oculus, Mexico) will be applied by the patient to the skin at the site of the imminent surgical incision.
Arm 1. Standard care + Microdacyn applied twice daily for 7 days pre-operatively
Arm 2. Standard care + Microdacyn applied four times daily for 2 days pre-operatively
Arm 3. Standard care + Microdacyn applied on
To compare the efficacy of additional Microdacyn with standard practices for prevention of intra-operative wound contamination in clean surgical procedures. Microdacyn hydrogel (Oculus, Mexico) will be applied by the patient to the skin at the site of the imminent surgical incision. Arm 1. Standard care + Microdacyn applied twice daily for 7 days pre-operatively Arm 2. Standard care + Microdacyn applied four times daily for 2 days pre-operatively Arm 3. Standard care + Microdacyn applied once pre-operatively on the day of surgery Arm 4. Standard care (no Microdacyn)
Sponsors
Richard Everts
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
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 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.
Outcome results
None listed