Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001233516
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
11/11/2015
Date last updated
2/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized trial of doxycycline and Microdacyn versus standard care for prevention of intra-operative wound contamination in clean orthopaedic and pacemaker insertion procedures
Scientific title
Randomized trial of doxycycline and Microdacyn versus standard care for prevention of intra-operative wound contamination and postoperative infection in clean elective surgical procedures
Secondary ID [1] 287657 0
None
Universal Trial Number (UTN)
U111-11726788
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative wound contamination 296487 0
postoperative infection 296613 0
Condition category
Condition code
Infection 296742 296742 0 0
Other infectious diseases
Surgery 296853 296853 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 293051 0
Prevention
Intervention code [2] 293143 0
Treatment: Drugs
Comparator / control treatment
Control: Current standard treatment:
Preoperative 2% chlorhexadine wash of surgical site (on day of surgery)
2% chlorhexadine with alcohol skin prep
2gm Cephazolin IV; 1x at induction of anaesthesia and 2x postop doses (8 hourly)
Control group
Active

Outcomes
Primary outcome [1] 296360 0
Compare the mean number of bacteria isolated from wound swabs in the three study groups.
Timepoint [1] 296360 0
2x Swabs taken at start and end of operation
Secondary outcome [1] 318237 0
Incidence of Post-operative wound infection in the three study groups.
This will be assessed clinically and based on the definitions of wound infection by the New Zealand Health Quality and Safety Commission Surgical Site Infection improvement programme, which in turn are based on the National Healthcare Safety Network definitions (Centres for Disease Control and Prevention 2015. Procedure-associated Events. www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf?agree=yes&next=Accept).
Timepoint [1] 318237 0
Patients will be routinely followed up at 21-28 days and one year post op via the research assistant asking them questions. If they experience symptoms at other time points they will also be assessed and included in the data.
Secondary outcome [2] 318240 0
Incidence of Treatment-emergent adverse events (TEAE) in the three study groups will be recorded via the research assistant asking them questions.
Examples of the TEAE's for doxycycline are indigestion, heartburn, feeling sick, vomiting, stomach upset or diarrhoea, vaginal thrush, headache, sunburn, rash and dizziness
TEAE's for Microdacyn is skin irritation
Timepoint [2] 318240 0
Each day of the two days of preoperative prophylactic treatment, the DOS and day one post op

Eligibility
Key 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).
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, 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
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)
will be done by simple computerized sequence generation, stratified by operation type (shoulder procedure, other joint prosthesis insertion, pacemaker insertion, other orthopaedic procedures) and in blocks (www.random.org – integer sets).
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The recruitment target for the study is upto 200 patients to account for dropouts and to increase statistical significance.. The primary outcome measure is quantitative bacterial contamination of the wound. Based on previous data, we are expecting to grow from 0 to 1000 bacteria per case. Based on a sample size of 150 participants (50 in each arm), the outcome of mean number of contaminating bacteria isolated from each wound, a possible reduction in bacterial load of 75 to 95% with one or both treatments, and a significant reduction in contamination deemed to be 50 to 75%, we have been advised by a statistician that we might achieve a statistically significant result if the participants are considered together. The participants, however, will have undergone a variety of procedures so subgroup analysis based on procedure is unlikely to achieve statistically significant results. We also do not expect to be able to achieve a statistically significant result for the outcome of wound infection rate, given that the rate of infection is likely to be less than 2%.

Interim analysis of the results will be undertaken once a month. If the study shows a significant difference in efficacy or safety between the three groups at interim analysis then the study might be terminated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2015
Actual
30/11/2015
Date of last participant enrolment
Anticipated
25/11/2016
Actual
1/02/2016
Date of last data collection
Anticipated
1/02/2017
Actual
1/02/2017
Sample size
Target
200
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 7230 0
New Zealand
State/province [1] 7230 0
Nelson

Funding & Sponsors
Funding source category [1] 292216 0
Other Collaborative groups
Name [1] 292216 0
Nelson Medical Education and Research Trust Fund
Country [1] 292216 0
New Zealand
Primary sponsor type
Individual
Name
Mr Philip Knight, Orthopaedic Surgeon,
Address
OSN Limited, 105 Collingwood St, Nelson 7010
Country
New Zealand
Secondary sponsor category [1] 290891 0
None
Name [1] 290891 0
None
Address [1] 290891 0
None
Country [1] 290891 0
Other collaborator category [1] 278657 0
Individual
Name [1] 278657 0
Dr Richard Everts, Infectious Diseases Specialist,
Address [1] 278657 0
Nelson Bays Primary Health, PO Box 1776, Nelson 7040,
Country [1] 278657 0
New Zealand
Other collaborator category [2] 278659 0
Individual
Name [2] 278659 0
Amelia Howard-Hill - Registered Nurse
Address [2] 278659 0
OSN Limited, 105 Collingwood St, Nelson 7010
Country [2] 278659 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293683 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 293683 0
Ethics committee country [1] 293683 0
New Zealand
Date submitted for ethics approval [1] 293683 0
05/11/2015
Approval date [1] 293683 0
23/11/2015
Ethics approval number [1] 293683 0
15/STH/203

Summary
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
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
ethics meeting arranged for 17.11.2015
Attachments [1] 582 582 0 0
/AnzctrAttachments/369475-Pre-read information sheet - RCT doxy Microdacyn wound contam clean procedures.doc
Attachments [2] 583 583 0 0
/AnzctrAttachments/369475-Doxycycline information sheet - RCT doxy Microdacyn wound contam clean procedures.doc

Contacts
Principal investigator
Name 60958 0
Mr Philip Knight, Orthopaedic Surgeon,
Address 60958 0
OSN Limited, 105 Collingwood St, Nelson 7010
Country 60958 0
New Zealand
Phone 60958 0
+64(0)35483455
Fax 60958 0
Email 60958 0
[email protected]
Contact person for public queries
Name 60959 0
Dr Richard Everts, Infectious Diseases Specialist,
Address 60959 0
Nelson Bays Primary Health, PO Box 1776, Nelson 7040,
Country 60959 0
New Zealand
Phone 60959 0
+64(0)274633284
Fax 60959 0
Email 60959 0
[email protected]
Contact person for scientific queries
Name 60960 0
Dr Richard Everts, Infectious Diseases Specialist,
Address 60960 0
Nelson Bays Primary Health, PO Box 1776, Nelson 7040,
Country 60960 0
New Zealand
Phone 60960 0
+64(0)274633284
Fax 60960 0
Email 60960 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.