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Trial registered on ANZCTR


Registration number
ACTRN12617000475347
Ethics application status
Approved
Date submitted
14/03/2017
Date registered
31/03/2017
Date last updated
26/10/2018
Date data sharing statement initially provided
26/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skin Preparation for Surgical-Site Antisepsis in Gynaecological Laparoscopic Surgeries: A Double Blinded Randomised Controlled Trial.
Scientific title
The research is continuing as a fully powered study (same protocol as the pilot study) and hence is not a pilot study anymore.
Secondary ID [1] 291448 0
Nil known
Universal Trial Number (UTN)
U1111-1194-2539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infections 302476 0
Condition category
Condition code
Infection 302036 302036 0 0
Studies of infection and infectious agents
Surgery 302088 302088 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Skin preparation solution prior to gynaecological laparoscopic surgery.

Arm 1: Abdominal preparation with Tinted red Chlorhexidine Gluconate 2% w/v, Ethanol 70% v/v (PharmAust) and Vaginal/Vulvar preparation with Aqueous-based Chlorhexidine Gluconate 2% solution .

Arm 2: Abdominal preparation withiodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO) solution and Vaginal/Vulvar preparation with Riodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO).

Arm 3: Abdominal preparation with Alcohol-based Povidone-Iodine 10% solution and Vaginal/Vulvar preparation with Riodine Antiseptic Solution- Povidone-Iodine 10% w/v equivalent to 1% w/v available Iodine (Aqueous based, HERRO).

Each of those solutions would be used to clean the skin prior to surgery. This action will be done by one of the surgeons one time prior to surgery.
Intervention code [1] 297489 0
Prevention
Comparator / control treatment
Active Control- Abdominal Aqueous-based Poviodine-Iodine solution and Vaginal/Vulvar Aqueous-based Poviodine-Iodine solution

Active Control-Abdominal Alcohol-based Poviodine-Iodine solution and Vaginal/Vulvar Aqueous-based Poviodine-Iodine solution
Control group
Active

Outcomes
Primary outcome [1] 301459 0
1. Rates of superficial infections at the surgical site as defined by the CDC
2. Rates of deep infections at the surgical site as defined by the CDCT

Infection would be assessed as per CDC guidelines with physical examination OR laboratory methods (e.g. swabs).

To compare the rates of superficial and deep skin infections in gynaecological laparoscopic surgeries amongst three methods of skin preparation. This is a composite outcome that will be assessed by clinical examinations in two points of time after surgery.
Timepoint [1] 301459 0
6-8 days and 30 days after surgery
Secondary outcome [1] 332728 0
To compare rates of organ/space infections such as urinary tract infection and endometritis amongst three methods of skin preparation. This is a composite outcome that will be assessed as per CDC guidelines with physical examination OR laboratory methods (e.g. swabs).
Timepoint [1] 332728 0
30 days after surgery

Eligibility
Key inclusion criteria
* Age 18 or above
* Planned laparoscopy for investigation and treatment of gynaecological disorders
* Patient agreement to participate in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of allergy to chlorhexidine, alcohol, or iodophors
* Evidence of infection at or adjacent to the operative site before surgery
* The perceived inability to follow the patient’s course for 30 days after surgery.
* Emergency laparoscopies.
* Patients with known or suspected pelvic inflammatory disease

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation was stratified according to the predicted antibiotic prophylaxis protocol. Randomisation was performed within the "R" statistics package, creating 3 groups-
1. No antibiotic prophylaxis
2. 2 grams of Cephazoline
3. 2 grams of Cephazoline + 400 mg of Metronidazole
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a power level of 80% and on the assumption that a 10% absolute difference between groups would be considered clinically significant (i.e. to promote change of practice), in order to perform a fully powered study- the required sample size of each group should be 198. Given that our study has 3 arms, we are extending the number of participants to 600.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7678 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 15596 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295914 0
Charities/Societies/Foundations
Name [1] 295914 0
AGES- Australian Gynaecological Endoscopy and Surgery Society.
Address [1] 295914 0
PO Box 717
Indooroopilly
QLD 4068
AUSTRALIA
Country [1] 295914 0
Australia
Primary sponsor type
Individual
Name
Dr Uri Dior
Address
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 294788 0
Individual
Name [1] 294788 0
A/Prof. Martin Healey
Address [1] 294788 0
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country [1] 294788 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297195 0
The Royal Women's Hospital Research and Ethics Committee
Ethics committee address [1] 297195 0
The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Ethics committee country [1] 297195 0
Australia
Date submitted for ethics approval [1] 297195 0
02/11/2016
Approval date [1] 297195 0
18/01/2017
Ethics approval number [1] 297195 0

Summary
Brief summary
Surgical Site Infections (SSI), including infections of the skin, subcutaneous tissue and internal organs, are one of the most common serious complications of surgery and anaesthesia. They are a leading cause of re-admissions and prolonged hospitalisations and they substantially increase the cost of care. Rates of SSI for individual procedures vary widely depending on the population, size of the hospital, type of surgery, experience of the surgeon and methods used for prevention and surveillance. Overall, it is estimated that SSI develops in up to 15 percent of patients undergoing surgical procedures.
Endoscopic gynaecologic surgery is a rapidly developing field. Laparoscopic surgery is nowadays used for many procedures that were traditionally performed via laparotomy. Up to date, there are no prospective studies that specifically evaluated the rates of SSI in laparoscopic gynaecologic surgeries or the preferred way of skin preparation to prevent them.
Gynaecology units 1 and 2 of The Royal Women's Hospital perform over 700 laparoscopies annually. All patients who undergo planned surgery present to clinic before surgery. We aim to perform a Randomised Controlled Double Blinded Study comparing 3 solutions of skin preparation containing alcohol or aqueous based Povidone-Iodine or Chlorhexidine. Our hypothesis is that Incisional and organ/space SSI rates would be similar throughout all groups. Patients would be followed-up one and four weeks after surgery and SSI rates would be compared amongst groups. SSI would be documented and defined as per the CDC guidelines. We are aiming to examine if we rates of surgical site infections can be reduced by using a specific solution for skin preparation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73302 0
Dr Uri Dior
Address 73302 0
The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73302 0
Australia
Phone 73302 0
+61 3 83452000
Fax 73302 0
Email 73302 0
uri.dior@thewomens.org.au
Contact person for public queries
Name 73303 0
Dr Uri Dior
Address 73303 0
The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73303 0
Australia
Phone 73303 0
+61 3 83452000
Fax 73303 0
Email 73303 0
uri.dior@gmail.com
Contact person for scientific queries
Name 73304 0
Dr Uri Dior
Address 73304 0
The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052
Country 73304 0
Australia
Phone 73304 0
+61383452000
Fax 73304 0
Email 73304 0
uri.dior@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Not applicable