Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001391460p
Ethics application status
Not yet submitted
Date submitted
5/10/2016
Date registered
7/10/2016
Date last updated
7/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized trial of pre-operative Microdacyn versus standard care for prevention of intra-operative wound contamination and post-operative infection in clean surgical procedures
Scientific title
Randomized trial of pre-operative Microdacyn versus standard care for prevention of intra-operative wound contamination and post-operative infection in clean surgical procedures
Secondary ID [1] 290268 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intra-operative wound contamination 300497 0
Post-operative wound infection 300498 0
Condition category
Condition code
Infection 300357 300357 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 296065 0
Prevention
Comparator / control treatment
Control: Current standard treatment. This includes skin preparation immediately pre-operatively with alcohol + chlorhexidine, prophylactic antibiotics (mostly cefazolin), pre-operative nasal povidone iodine for prosthetic joint surgery and antiseptic sutures
Control group
Active

Outcomes
Primary outcome [1] 299812 0
Compare the mean number of bacteria isolated from wound swabs in the four study groups.
Timepoint [1] 299812 0
2x swabs taken at the start of the operation and 2x swabs taken at the end of the operation
Secondary outcome [1] 328191 0
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).
Timepoint [1] 328191 0
21 to 28 days and 1 year post-operative
Secondary outcome [2] 328192 0
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.
Timepoint [2] 328192 0
1 to 2 days pre-operatively and 21 to 28 days post-operative

Eligibility
Key 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)
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved by the research assistant contacting the holder of the allocation schedule, who will be off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computerized sequence generation, stratified by operation type (shoulder
procedure, other joint prosthesis insertion, other orthopaedic procedure, non-orthopaedic surgical procedure) and in blocks (www.random.org – integer sets).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
An almost identical trial to this one was undertaken in November 2016 to January 2016. The number of swab samples with moderate to heavy growth (more than 11 colonies on at least one plate) was 20 of 130 (15%) in the standard group and 4 of 124 (3%) in the Microdacyn group. No statistical analysis has been done yet on these results. In the current study, there will be three Microdacyn groups with different duration of pre-operative treatment (a dosing study) and we expect similar efficacy compared with control in the 2-day and 7-day groups.

Standard descriptive statistics including means, medians, ranges, frequencies and percentages will be used to summarise baseline and post randomization measures. Outcomes will be compared between randomized groups using Chi-square, fisher’s exact tests and Mann-Whitney U tests as appropriate. A two-tailed p-value <0.05 will be taken to indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/11/2016
Actual
Date of last participant enrolment
Anticipated
7/02/2017
Actual
Date of last data collection
Anticipated
10/02/2018
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 8294 0
New Zealand
State/province [1] 8294 0
Nelson

Funding & Sponsors
Funding source category [1] 294640 0
Government body
Name [1] 294640 0
Accident Compensation Corporation
Country [1] 294640 0
New Zealand
Primary sponsor type
Individual
Name
Richard Everts
Address
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country
New Zealand
Secondary sponsor category [1] 293504 0
None
Name [1] 293504 0
Address [1] 293504 0
Country [1] 293504 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296075 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 296075 0
Ethics committee country [1] 296075 0
New Zealand
Date submitted for ethics approval [1] 296075 0
10/10/2016
Approval date [1] 296075 0
Ethics approval number [1] 296075 0

Summary
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69462 0
Dr Richard Everts
Address 69462 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 69462 0
New Zealand
Phone 69462 0
+64 3 5391170
Fax 69462 0
Email 69462 0
[email protected]
Contact person for public queries
Name 69463 0
Dr Richard Everts
Address 69463 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 69463 0
New Zealand
Phone 69463 0
+64 3 5391170
Fax 69463 0
Email 69463 0
[email protected]
Contact person for scientific queries
Name 69464 0
Dr Richard Everts
Address 69464 0
Nelson Bays Primary Health
PO Box 1776
Nelson 7040
Country 69464 0
New Zealand
Phone 69464 0
+64 3 5391170
Fax 69464 0
Email 69464 0
[email protected]

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