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The relationship between surgical wound environment and physiology in laparotomy patients.

Examining the relationship between the surgical wound environment, appearance, and physiology in laparotomy patients: A pilot prospective cohort study.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000347460
Enrollment
30
Registered
2025-04-23
Start date
2025-07-02
Completion date
2026-06-02
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

During open abdominal surgery, the surgeon exposes patients’ internal tissues to the cold dry operating room. This increases the risk of patients developing intraoperative hypothermia and surgical site desiccation. To combat this, surgical teams use multiple methods to keep patients warm and surgical sites moist intraoperatively. One of these methods is surgical humidification, the insufflation of warm humidified gas to the surgical site. Surgical humidification has been shown to significantly improve laparotomy patient temperature and protect against peritoneal damage. This pilot prospective observational cohort study will compare the effect of cold dry room air or warm moist carbon dioxide gas on surgical site physiology. The quality of tissue health and hydration will be assessed by surgeon inspection of the surgical site using a visual analogue scale and blinded surgeon scoring of surgical site images. Intraoperative surgical site temperature and oxygenation levels will also be imaged and assessed. Systemic inflammation marker C-reactive protein will also be assessed pre- and post-operation. This is the first-time surgical humidification will be assessed on its ability to improve intraoperative surgical site appearance, hydration, and oxygenation in elective laparotomy patients.

Interventions

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. Particip

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

Sponsors

Fisher & Paykel Healthcare Ltd
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026