Effect of air humidification and warming on surgical site temperature during spinal surgery.

Not Applicable

Completed

• Conditions: Surgical wound heat loss; Orthopaedic surgery; Surgery - Other surgery

• Registration Number: ACTRN12620001321932
• Lead Sponsor: Fisher & Paykel Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-07
• Study Completion: 2023-01-31
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal wound temperature, measured using a thermal camera.<br>(The maximum, minimum, and average temperature within the wound area for each timepoint will be extracted from the thermal image with computer post-processing.) [Upon incision, and thereafter at 15-minute intervals until wound closure. Additionally, one post-operative measurement will be made in the recovery room / PACU, approximately 30 minutes after wound closure.]

Secondary Outcome Measures

Name	Time	Method
Core body temperature as measured by nasopharyngeal probe[Upon incision, and thereafter at 15-minute intervals until wound closure. ]