None listed
Conditions
Brief summary
When the body is opened during surgery, internal tissues are exposed to the air in the operating theatre, which is cold and dry compared to body conditions. The purpose of the study device is to prevent drying and cooling of the surgical wound and internal tissues, by gently delivering warm and humidified air over the wound. The goal of the study is to measure the effectiveness of the study device at maintaining the normal temperature of the internal tissues. The Air Surgical Humidification device being studied is designed to deliver warm (~37°C) saturated air (~ greater than or equal to 95% relative humidity) to a surgical wound intraoperatively, to prevent evaporation and local heat loss. It comprises a patient interface and heated delivery circuit, which is connected to a humidification system and flow source, and is designed to create an even distribution of flow over the open wound. Twenty eight patients aged 22 years and older undergoing elective 1 or 2 level spinal decompression (discectomy and/or laminectomy) between L1-S1 vertebrae who fit the study criteria and consent to take part will be randomized to receive standard of care (no intervention) or Air Surgical Humidification during their surgery. A thermal photo of the surgical site (without any identifying information) will be taken upon incision, and thereafter at 15-minute intervals during the surgery until wound closure. Core temperature from a nasopharyngeal probe will also be recorded immediately upon incision and at 15-minute intervals during the surgery until closure. Post-operatively, thermal photos (without any identifying information) will be taken of the dressed surgical wound while the patient is in recovery, 30 minutes after wound closure during routine post op checks. Any adverse events and/or re-admissions will be recorded for approximately 6 weeks until the patient's routine post op visit and clinical follow-up. Re-admissions and clinical visits for any reason will be monitored via Middlemore Hospital's patient tracking system which flags the patient's participation in a clinical study on their patient records. The data resulting from this study will allow us to determine whether warmed and humidified air can help to maintain normal tissue temperature during surgery.
Interventions
Brief name of intervention: Air Surgical Humidification
Air Surgical Humidification is a therapy designed and manufactured by Fisher and Paykel Healthcare Ltd. to deliver warm (~37°C) saturated air (~95% relative humidity) to the surgical wound intraoperatively.
Air Surgical Humidification comprises a patient interface that is connected to a heated circuit, humidification system and flow source, and is designed to evenly distribute flow of warm humidified air over the open wound. The patient
Brief name of intervention: Air Surgical Humidification Air Surgical Humidification is a therapy designed and manufactured by Fisher and Paykel Healthcare Ltd. to deliver warm (~37°C) saturated air (~95% relative humidity) to the surgical wound intraoperatively. Air Surgical Humidification comprises a patient interface that is connected to a heated circuit, humidification system and flow source, and is designed to evenly distribute flow of warm humidified air over the open wound. The patient interface delivers warm humidified air at a flow rate of 10 L/min to create a local atmosphere of warm (~37°C) saturated air in the open surgical wound. Twenty-eight patients who fit the study criteria and consent to participate will be randomized, 1:1, to receive standard of care (no intervention) or Air Surgical Humidification (intervention) during their spinal decompression surgery. The intervention will be applied by an orthopaedic surgeon to patients in person, individually to each patient, during their spinal decompression surgery procedure only (as soon as the incision is made until the surgical incision wound is closed), with the surgery performed in the hospital. The intervention will not be personalised, titrated or adapted to individuals or groups of individuals in the intervention arm. Standard of care will be followed in all other aspects of the procedure as is routine at the participating hospital for patients undergoing elective spinal decompression surgery. Adherence to the intervention, or any protocol deviations and/or adverse events will be recorded in the Case Report Form. Further, the times at which the incision is made, the intervention is applied, the surgical wound is closed, and the intervention is removed will also be recorded on the Case Report Form.
Sponsors
Fisher & Paykel Healthcare Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Undergoing elective 1 or 2 level spinal decompression (laminectomy or laminectomy and discectomy) between L1-S1 vertebrae, performed by a participating surgeon 2) Has had adequate time to consider their participation in the study and discuss it with family and friends, and have their questions answered by a member of the study team 3) Understands the risks and benefits of the study, and able to provide written informed consent.
Exclusion criteria
1) Undergoing any concomitant procedure 2) Procedures where the final wound incision length could foreseeably be longer than 160mm. 3) Skin sensitivity where 3M™ Ioban™ 2 surgical dressing cannot be used 4) Patients with active medical or psychiatric conditions or participation in another clinical trial which, in the opinion of the PI / operating surgeon, would compromise (or interfere with) their ability to participate in the study, or means that it would not be in their best interest to participate.
Outcome results
None listed