RecruitingACTRN12625001110471

A study to assess tissue health in patients undergoing orthopaedic surgery using a surgical humidification system

Wound Assessment and Response of Muscle Tissue with HumiGard™ (WARMTH) in Orthopaedic Surgery: A Randomised Controlled Pilot Trial

Sponsor

Fisher and Paykel Healthcare Ltd.

Enrollment

20 participants

Start Date

Dec 4, 2025

Study Type

Interventional

Conditions

Patients undergoing posterior spine surgery Tissue health

Summary

During open orthopaedic surgery, the surgical site is exposed to the cold (18-22°C) and relatively dry (20-60% relative humidity) theatre environment, contrasting with the patient's internal conditions. This exposure exacerbates evaporative cooling from the open wound, increasing the risk of local hypothermia and tissue desiccation. Surgical humidification, the insufflation of warm humidified gas into the surgical site, has shown significant tissue preservation benefits and a trend towards reducing surgical site infections in laparotomy and cardiac surgeries. This randomised controlled pilot study will evaluate the HumiGard™ Surgical Humidification (Air) system (Fisher and Paykel Healthcare Ltd, Auckland, NZ) in preserving tissue health in open orthopaedic spinal wounds. We hypothesise that maintaining physiological conditions will preserve tissue health, leading to better wound healing and reduce the risk of infections. Tissue health will be assessed through histological analysis of tissues from the surgical wound. Findings may influence intraoperative practices and support HumiGard as a protective measure in open spinal surgeries.

Eligibility

Sex: Both males and femalesMin Age: 22 Yearss

Plain Language Summary

Simplified for easier understanding

When the body is opened during surgery, the tissues are exposed to the cool, dry air of the operating theatre — quite different from the warm, moist environment they are used to inside the body. This can cause the surgical wound to lose heat and dry out, potentially harming the tissue and increasing the risk of wound infection. Surgical humidification — blowing warm, moist air over the open wound — has been shown to help in abdominal and heart surgeries, but has not yet been studied in spinal surgery. This trial will test a device called HumiGard, which delivers warm humidified gas to open spinal wounds during surgery. After the operation, tissue samples taken from the wound will be examined under a microscope to see whether the tissues are healthier in patients who received the humidification treatment. You may be eligible if you are 22 years or older, are scheduled for a planned (non-emergency) open posterior spinal surgery lasting at least two hours, and are able to give written consent. People having revision (repeat) spinal surgery or procedures requiring multiple incisions or very long incisions (over 260mm) are not eligible.

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Interventions

This randomised, single-blinded, controlled pilot study aims to evaluate the effectiveness of the HumiGard™ Surgical Humidification (Air) System in preserving tissue health during open orthopaedic spinal surgery. The HumiGard™ (Air) System (Fisher and Paykel Healthcare Ltd, Auckland, NZ) is an intraoperative medical device designed to support the maintenance of patient temperature and tissue hydration during open orthopaedic surgery. It delivers warm, humidified medical-grade air directly to the surgical site via a soft diffuser suitable for incisions up to 26 cm. The diffuser is positioned over the incision to ensure consistent coverage of warm, humidified air across the surgical wound. For this study, the device will be set up for all participants undergoing open spinal surgery. Immediately prior to surgery, the participants will be randomly assigned to one of two groups: Arm 1 – HumiGard ON group: The device will be activated during surgery. Arm 2 – HumiGard OFF group: The device will be set up but not turned on. Tissue health will be assessed through the intraoperative collection of muscle tissue biopsies (no larger than 5x5x5 mm) at pre-determined timepoints. Biopsies will be taken by the operating surgeon using standard sterile techniques and will not alter the planned surgical procedure. Surgical site images will be captured using FLIR camera (Teledyne Technologies) at the same time points as the tissue biopsies. These images will provide a temperature map of the observed area. The anticipated duration of the HumiGard use is up to 3 hours from the first incision until wound closure. The operating surgeon will attach the diffuser to the surgical site for all participants and the theatre nurse will either turn HumiGard on or leave HumiGard off depending on the participants randomisation. Adherence to the intervention will be monitored by verifying the device's activation status via its control panel and recording the duration of use in the data collection report. The HumiGard™ System is approved for use in open orthopaedic surgery by regulatory authorities in Australia (TGA), New Zealand (Medsafe), and Canada (Health Canada),

Locations(1)

Hamilton, New Zealand

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ACTRN12625001110471