Trial Review

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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] 293247 0
None
Universal Trial Number (UTN)
U1111-1137-6070
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal surgery 305295 0
Condition category
Condition code
Surgery 304600 304600 0 0
Other surgery
Oral and Gastrointestinal 304601 304601 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 304602 304602 0 0
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] 299510 0
Treatment: Devices
Intervention code [2] 299511 0
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] 303832 0
To quantify the number of bacteria present in the open surgical wound as determined by taking swabs for qPCR.
Timepoint [1] 303832 0
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] 340248 0
Bacterial load as determined by taking swabs during surgery for culture of wound specimens (colony forming units).
Timepoint [1] 340248 0
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] 340249 0
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] 340249 0
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?
No
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
10
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 9331 0
New Zealand
State/province [1] 9331 0
Auckland

Funding & Sponsors
Funding source category [1] 297876 0
Commercial sector/Industry
Name [1] 297876 0
Fisher and Paykel Healthcare
Country [1] 297876 0
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] 296931 0
University
Name [1] 296931 0
University of Auckland
Address [1] 296931 0
12th Floor, Support Building, Auckland City Hospital
Park Road,
Grafton
Auckland
1010
Country [1] 296931 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298926 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 298926 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 298926 0
New Zealand
Date submitted for ethics approval [1] 298926 0
22/05/2015
Approval date [1] 298926 0
15/07/2015
Ethics approval number [1] 298926 0
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 78674 0
Prof John Windsor
Address 78674 0
12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010
Country 78674 0
New Zealand
Phone 78674 0
+6493737599
Fax 78674 0
+6493779656
Email 78674 0
[email protected]
Contact person for public queries
Name 78675 0
Ms Jennifer Mackie
Address 78675 0
12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010
Country 78675 0
New Zealand
Phone 78675 0
+64212751203
Fax 78675 0
Email 78675 0
[email protected]
Contact person for scientific queries
Name 78676 0
Prof John Windsor
Address 78676 0
12th Floor, Support Building, Auckland City Hospital,
Park Road, Grafton,
Auckland
1010
Country 78676 0
New Zealand
Phone 78676 0
+6493737599
Fax 78676 0
+6493779656
Email 78676 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23571Clinical study report   

Results publications and other study-related documents

Documents added manually
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Documents added automatically
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