ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001558314

Ethics application status

Approved

Date submitted

1/11/2017

Date registered

15/11/2017

Date last updated

17/07/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of warm humidified insufflated carbon dioxide on wound bacterial load in open elective gastrointestinal surgery: a pilot investigation.

Scientific title

Effect of warm humidified insufflated carbon dioxide on wound bacterial load in open elective gastrointestinal surgery: a pilot investigation.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1137-6070

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

gastrointestinal surgery

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Infection

Studies of infection and infectious agents

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients will be randomly allocated to receive CO2 insufflation during their surgical procedure or standard care (Surgery without any additional intervention). The CO2 will be delivered into the open peritoneal cavity by the Fisher and Pykel HumigardTM surgical humidification system throughout the duration of the surgery (from incision to surgical close).

The HumigardTM surgical humidification system creates a local atmosphere of CO2 heated to 37oC at 100% relative humidity which is thought to decrease airborne contamination, reduce bacterial growth and decreased heat loss during surgery.

Intervention arm - Consented patients undergoing Whipples procedure at Auckland City Hospital will receive insufflated CO2 in the surgical wound throughout the procedure. The Humigard TM device will be set up and operated by the consultant surgeon and the surgical team in the operating theatre. Swabs will be taken at time of incision, 1 hour, 2 hours and at surgical wound close. These swabs will be analysed for bacterial growth and compared against the patients how did not receive CO2. At time of incision and closure, 2 6mm skin biopsies will be taken along the incision line. This is to determine wound edge tissue response. A research nurse will be present throughout the procedure and will assist in sample collection and Humigard maintenance.

All patients will be followed by a research nurse at 30 days over the phone to assess if there has been any surgical site infection.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Prevention

Comparator / control treatment

Control arm
All procedures will be carried out as described in the intervention arm but without the use of the Humigard device during surgery. This is the active control group and patients will receive standard of care with additional swabs and a 30 day follow up phone call.

Control group

Active

Outcomes

Primary outcome [1]

To quantify the number of bacteria present in the open surgical wound as determined by taking swabs for qPCR.

Timepoint [1]

qPCR swabs are taken after incision but before retraction, 1 hour into surgery, 2 hours into surgery and before closure and before retractors are removed.

A qPCR swab is also taken when the surgical dressing is removed at 5 days post-surgery. If evidence of SSI is present at day 5, discharge or 30 days post surgery then the qPCR swab taken at day 5 post-surgery will be sent for analysis.

Secondary outcome [1]

Bacterial load as determined by taking swabs during surgery for culture of wound specimens (colony forming units).

Timepoint [1]

Bacterial culture swabs are taken after incision but before retraction, 1 hour into surgery, 2 hours into surgery and before closure and before retractors are removed.

Secondary outcome [2]

Wound edge tissue response as determined by analysis of 6mm tissue biopsies. These are taken at time of main abdominal incision and after 2 hours of surgery. Each biopsy will be either immediately fixed or frozen for tissue analysis. Analysis may include: gene expression arrays, immunohistochemistry, histology, protein profiles, metabolite and lipid profiles, cytokine and other appropriate laboratory investigations to measure the response of the skin edge to different gaseous environments.

Timepoint [2]

2 x 6mm tissue biopsies will be taken at time of main abdominal incision and after 2 hours of surgery (4 in total).

Eligibility

Key inclusion criteria

1. Scheduled to undergo upper gastrointestinal surgical procedures longer than 120 minutes involving an open midline laparotomy incision.
2. Able to give informed consent
3. Male or female between 18 and 65 years of age
4. HbA1c less than 49 mmol/mol

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Evidence, preoperatively, of any of the following: sepsis, severe sepsis, or septic shock
2. BMI over 30
3. Currently abdominal wall infection/surgical site infection secondary to previous laparotomy/laparoscopy or form any other cause
4. History of laparotomy within the last 60 days
5. Immunological disease (e.g. HIV/AIDS)
6. Systemic steroid use or other immunosuppressant medication
7. ASA score over and including 4
8. Uncontrolled diabetes mellitus
9. Current smoker or not willing to stop smoking 30 days prior to surgery
10. Wound protector use for the surgery

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)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

As the study is a pilot study a total of 10 patients will be enrolled in the study (5 per treatment group).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

20/11/2017

Actual

25/01/2018

Date of last participant enrolment

Anticipated

31/12/2018

Actual

Date of last data collection

Anticipated

28/02/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fisher and Paykel Healthcare

Address [1]

15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Fisher and Paykel Healthcare

Address

15 Maurice Paykel Place
East Tamaki
Auckland 2013

Country

New Zealand

Secondary sponsor category [1]

University

Name [1]

University of Auckland

Address [1]

12th Floor, Support Building, Auckland City Hospital
Park Road,
Grafton
Auckland
1010

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

22/05/2015

Approval date [1]

15/07/2015

Ethics approval number [1]

15/NTA/66

Summary

Brief summary

Surgical site infection (SSI) is an infection which can develop in the wound created by a surgical procedure. SSI is a potential side effect of any surgical procedure. The purpose of this investigation is to provide data for helping design a larger controlled study which will investigate whether blowing warm, humidified carbon dioxide (CO2) into the surgical cavity during surgery can reduce the number of bacteria in the surgical wound, potentially reducing the risk of SSI. We are also interested in how the gas treatment alters the way your skin wound edge responds and heals. It is possible that the gas may improve the healing process after surgery. 

Participants undergoing elective gastrointestinal surgery at Auckland City Hospital who meet the inclusion and exclusion criteria will be offered the opportunity to participate in the pilot study. 

If patients meet the above criteria and choose to take part in the study, they will be randomised (selected by chance by a computer) to receive the CO2 treatment or standard care (no CO2). If randomised into the CO2 treatment group, warm humidified CO2 gas will be slowly insufflated (blown) into the abdominal cavity during the planned surgery. The CO2 gas is delivered by a small, flexible, non-invasive tube which is placed inside the surgical wound during the operation. 

This trial will take 30 days to complete, not including an initial assessment to check if the patient meets the inclusion and exclusion criteria. There will be 4 scheduled assessments. These assessments will be undertaken during the standard routine check-up expected after  surgery so will not take any additional time. Assessments will be made at the following time points. Day 1 (surgery), Day 5 (in-patient), Discharge, Day 30 Follow-Up Visit. 

To measure the number of bacteria in the wound, a swab will be taken by gently wiping the edge of the wound of all participants. Samples will be taken by the surgeon while the patient is under an anesthesia at the beginning of the surgery; 1 hour into the procedure; 2 hours into the procedure; and at the end of the surgery before the surgical wound is closed.

In addition two sets of two small biopsies (small samples of your skin wound) during the operation will be taken. These biopsies are taken while the patient is under anesthesia from along the skin edges that are already part of the main operation wound. They will be inside the area of the main operation wound and will not make the scar any longer.

On Day 5, the surgical dressing will be removed at 48hrs post-surgery, and the wound will be reviewed by a nurse to check for any potential SSI. 

At discharge the surgical wound will be reviewed by a nurse to check for any potential SSI. 

The patient will be contacted again at 30 days to discuss any SSI have developed.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof John Windsor

Address

12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010

Country

New Zealand

Phone

+6493737599

Fax

+6493779656

j.windsor@aickland.ac.nz

Contact person for public queries

Name

Jennifer Mackie

Address

12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010

Country

New Zealand

Phone

+64212751203

Fax

j.mackie@auckland.ac.nz

Contact person for scientific queries

Name

John Windsor

Address

12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010

Country

New Zealand

Phone

+6493737599

Fax

+6493779656

j.windsor@aickland.ac.nz

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

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Documents added automatically

No additional documents have been identified.

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