ANZCTR - Registration

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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

23/07/2019

Date data sharing statement initially provided

26/10/2018

Date results provided

23/07/2019

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

Skin Preparation for Surgical-Site Antisepsis in Gynaecological Laparoscopic Surgeries: A Double Blinded Randomised Controlled Trial.

Secondary ID [1]

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

Condition category

Condition code

Infection

Studies of infection and infectious agents

Surgery

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]

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]

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]

6-8 days and 30 days after surgery

Secondary outcome [1]

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]

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

Sex

Females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

28/02/2017

Date of last participant enrolment

Anticipated

31/12/2018

Actual

26/10/2018

Date of last data collection

Anticipated

Actual

29/11/2018

Sample size

Target

600

Accrual to date

Final

661

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

AGES- Australian Gynaecological Endoscopy and Surgery Society.

Address [1]

PO Box 717
Indooroopilly
QLD 4068
AUSTRALIA

Country [1]

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]

Individual

Name [1]

A/Prof. Martin Healey

Address [1]

The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital Research and Ethics Committee

Ethics committee address [1]

The Royal Women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2016

Approval date [1]

18/01/2017

Ethics approval number [1]

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

Dr Uri Dior

Address

The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61 3 83452000

Fax

uri.dior@thewomens.org.au

Contact person for public queries

Name

Uri Dior

Address

The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61 3 83452000

Fax

uri.dior@gmail.com

Contact person for scientific queries

Name

Uri Dior

Address

The Royal women's Hospital
20 Flemington Rd
Parkville
VIC 3052

Country

Australia

Phone

+61383452000

Fax

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Basic results	No		372561-(Uploaded-20-07-2020-03-27-29)-Basic results summary.docx
Plain language summary	No	The research question was if one skin preparation ... [More Details]
Study results article	Yes	8/07/2020 Dior UP, Kathurusinghe S, Cheng C, Re... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of Surgical Skin Antisepsis on Surgical Site Infections in Patients Undergoing Gynecological Laparoscopic Surgery: A Double-Blind Randomized Clinical Trial.	2020	https://dx.doi.org/10.1001/jamasurg.2020.1953

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically