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Trial registered on ANZCTR


Registration number
ACTRN12625000347460
Ethics application status
Approved
Date submitted
7/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between surgical wound environment and physiology in laparotomy patients.
Scientific title
Examining the relationship between the surgical wound environment, appearance, and physiology in laparotomy patients: A pilot prospective cohort study.
Secondary ID [1] 314146 0
CIA-345
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing general laparotomy surgery 336973 0
Condition category
Condition code
Surgery 333437 333437 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In Dunedin Hospital some general surgical teams use the F&P HumiGard™ Surgical Humidification device (Fisher and Paykel Healthcare Ltd, Auckland, NZ) as an additional method to maintain patient temperature and tissue hydration during surgery, and some surgical teams do not. Based on the inclusion criteria and patient consent we will observe and collect measurement data from 15 cases that do not use surgical humidification (control group) and 15 cases that do use surgical humidification. Participants are not randomised and receive standard care according to the surgeon’s clinical practice.
HumiGard™ is to be used intraoperatively during surgery according to the surgeons standard clinical practice. The HumiGard system is comprised of a patient interface (SI400), tubing kit (ST340), humidifier (SH875), and flow control (900SH701). HumiGard™ delivers warm and moist carbon dioxide gas to the patient’s surgical site intraoperatively and is designed to keep patients warm and their surgical site moist during surgery.
Data Collection
Preoperative Observations Relevant demographic and clinical characteristics will be retrieved from patients' electronic medical records, including:
• Date of birth, gender, ethnicity, weight, height, body mass index (BMI)
• American Society of Anaesthesiology (ASA) scores and National Early Warning Score 2 (NEWS2)
• Smoking, vaping, or nicotine patch usage
• Medical history (e.g., diabetes, hypertension, prior abdominal surgeries, comorbidities, concomitant medications, current diagnosis, and reason for surgery)
Intraoperative Observations
Key surgical and patient variables will be recorded, such as:
• Time of induction and operating theatre temperature at induction
• Patient warming methods (if applicable)
• Surgical incision length and location, time of skin incision, and retractor placement
• Timing of HumiGard™ activation and deactivation (if applicable)
• Core body temperature monitoring (if routinely recorded), including probe type and hourly temperature measurements from induction to the end of surgery
• Systemic blood gas analysis (if conducted), noting blood draw site and final pH, pO2, and pCO2 values prior to closure
• Irrigation fluid type, timing, approximate volume, and temperature used intraoperatively
• Estimated blood loss, transfusion requirements (units)
Postoperative Observations
Standard postoperative monitoring will include:
• Daily C-reactive protein (CRP) blood tests from postoperative day 1 to day 5
• Patient arrival and discharge times from the Post-Anaesthesia Care Unit (PACU)
• Core body temperature (if routinely measured) upon PACU arrival and discharge
• Hospital length of stay, including admission, surgery, and discharge dates/times
• Documentation of known incisional surgical site infections (SSI) or ileus until discharge
• Recording of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), and serious adverse device effects (SADEs) from incision to discharge. Wound-related complications (e.g., seroma, hematoma, wound dehiscence, hernia, SSI) tracked up to 30 days post-operation
Additional Research Procedures
As part of the research component ooutside of standard hospital practice, participants will undergo:
• A one-time preoperative CRP blood test before surgical incision
• Non-invasive Intraoperative imaging of the surgical site at the start and end of surgery to assess tissue appearance, temperature, and oxygenation.
• A patient-reported wound healing questionnaire (Bluebelle Wound Healing Questionnaire) completed 30 days post-operation
Intervention code [1] 330734 0
Not applicable
Comparator / control treatment
The control group include cases which do not use HumiGard to deliver warm humidified gas to the surgical site during laparotomy.
Control group
Active

Outcomes
Primary outcome [1] 341005 0
Macroscopic appearance of the surgical site
Timepoint [1] 341005 0
Start (after initial incision) and end of surgery (prior to closure)
Primary outcome [2] 341093 0
Surgical site tissue temperature
Timepoint [2] 341093 0
Start (after initial incision) and end of surgery (prior to closure)
Primary outcome [3] 341094 0
Surgical site tissue oxygenation
Timepoint [3] 341094 0
Start (after initial incision) and end of surgery (prior to closure)
Secondary outcome [1] 445769 0
Systemic inflammation will be assessed by serum C-reactive protein levels.
Timepoint [1] 445769 0
pre-operatively and on post-operative days 1, 2, 3, 4, and 5 or prior to discharge (whichever is sooner).

Eligibility
Key inclusion criteria
• Patients aged greater than or equal to 18 years.
• Patients able to give informed consent.
• Patients undergoing elective laparotomy.
• Patients undergoing laparotomy lasting at least 60 minutes.
• Laparotomy involves any fixed retraction system except for wound protectors.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients undergoing minimally invasive surgery (robotic, laparoscopic).
• Patients undergoing emergency laparotomy.
• Patients undergoing laparotomy using wound protectors.
• Patients with prior laparotomy within 30 days.
• Patients on treatment for an active infection.
• Patients with a contraindication to CO2 insufflation.
• Patients with an American Society of Anaesthesiologists (ASA) Class 4 or 5.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The primary comparison groups will be composed of those who are undergo laparotomy surgery using surgical humidification versus those that undergo laparotomy surgery without surgical humidification.

For all major outcomes, variables will be tested for normality and summary statistics (e.g. mean, standard deviation, median, minimum and maximum for quantitative variables) will be presented for the study population. Continuous variables will be analyzed using the independent samples t-test, one way ANOVA (reporting mean and standard deviation) or Mann Whitney U (reporting median and interquartile range) test for parametric and non-parametric data respectively. Categorical data will be analyzed using the Chi-squared test or Fischer’s exact test where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/07/2025
Actual
Date of last participant enrolment
Anticipated
2/06/2026
Actual
Date of last data collection
Anticipated
2/07/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26953 0
New Zealand
State/province [1] 26953 0
Dunedin / Otago

Funding & Sponsors
Funding source category [1] 318656 0
Commercial sector/Industry
Name [1] 318656 0
Fisher & Paykel Healthcare Ltd
Country [1] 318656 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 321077 0
None
Name [1] 321077 0
Address [1] 321077 0
Country [1] 321077 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317270 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317270 0
Ethics committee country [1] 317270 0
New Zealand
Date submitted for ethics approval [1] 317270 0
12/11/2024
Approval date [1] 317270 0
10/03/2025
Ethics approval number [1] 317270 0
2025 FULL 21630

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140518 0
Mr John Woodfield
Address 140518 0
General Surgery Department, Dunedin Hospital, 201 Great King Street, Central Dunedin, Dunedin, New Zealand 9016
Country 140518 0
New Zealand
Phone 140518 0
+64 03 4740999 58830
Fax 140518 0
Email 140518 0
[email protected]
Contact person for public queries
Name 140519 0
Molly Abraham
Address 140519 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand 2013
Country 140519 0
New Zealand
Phone 140519 0
+64 095740123
Fax 140519 0
Email 140519 0
[email protected]
Contact person for scientific queries
Name 140520 0
Molly Abraham
Address 140520 0
Fisher & Paykel Healthcare, 15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand 2013
Country 140520 0
New Zealand
Phone 140520 0
+64 095740123
Fax 140520 0
Email 140520 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.