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Clinical Trials/NCT07524062
NCT07524062
Not yet recruiting
Not Applicable

The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery THERMS: THermography for Evaluation of Recovery and Monitoring of Surgical Wounds

Universitaire Ziekenhuizen KU Leuven1 site in 1 country120 target enrollmentStarted: April 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
120
Locations
1
Primary Endpoint
Thermal pattern changes associated with normal versus abnormal surgical wound healing

Overview

Brief Summary

This study investigates whether infrared thermography, a harmless and non-invasive thermal camera technique, can help monitor how surgical wounds heal after skin surgery. The goal is to detect wound problems earlier, such as infection or delayed healing, and to support doctors in making timely clinical decisions.

Detailed Description

This study evaluates whether infrared thermography, a non-invasive technique that measures skin surface temperature, can help monitor how surgical wounds heal after dermatologic procedures. Surgical wounds may develop complications such as infection, delayed healing, or graft problems, and these issues are often detected only when visible changes appear on the skin. Because temperature changes can occur earlier than visible symptoms, thermal imaging may provide an earlier signal that a wound is not healing normally.

Participants in this study will have thermal images taken at several routine follow-up moments after their skin surgery. The imaging procedure is quick, painless, and does not touch the skin. By comparing temperature patterns over time, the study aims to understand whether specific thermal changes are linked to normal recovery or to early signs of wound problems.

The information gained from this study may help determine if handheld thermal cameras could be used as a supportive tool in clinical practice. Earlier identification of healing problems may allow clinicians to adjust treatment sooner and improve patient outcomes, while also providing a simple, accessible way to document wound progress.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
  • Adult subjects (\>18 years of age) at time of enrolment
  • Patients undergoing a surgical excision under local anesthesia
  • Indications of the excisions were skin lesions suspected to be malignant, skin lesions confirmed to be malignant via prior biopsy

Exclusion Criteria

  • Patient has history of pre-existing diabetes type I and II
  • Patients with pre-existing chronic wound problems
  • Patients with renal dysfunction,
  • Patients with venous insufficiency confirmed via radiographic imaging
  • Patients who received radiotherapy in the affected area in the past
  • Patients with chronic steroid use in the past (\> 3 months) or a immunosuppressant medication history
  • Female who is pregnant

Arms & Interventions

Thermography Monitoring Arm

Experimental

Participants in this arm will undergo infrared thermography using the FLIR ONE PRO device at predefined postoperative time points. Thermal images of the surgical wound are captured without touching the skin. The temperature patterns are analyzed to monitor wound healing and to identify early signs of complications such as infection, delayed healing, or graft problems.

Intervention: Infrared thermography (Device)

Outcomes

Primary Outcomes

Thermal pattern changes associated with normal versus abnormal surgical wound healing

Time Frame: Postoperative days 2-4 and day 7 for Mohs surgery; day 7 and day 14 for trunk and extremities; postoperative weeks 1-4 for scalp grafts.

Changes in wound temperature patterns detected through infrared thermography will be evaluated to determine whether they correspond to normal healing or early signs of complications such as infection, delayed healing, or graft problems. Thermal images will be analyzed for differences in temperature distribution, symmetry, and progression over time.

Secondary Outcomes

  • Overall feasibility and clinical utility of infrared thermography(Postoperative days 2-4 and day 7 (Mohs); day 7 and day 14 (trunk/extremities); postoperative weeks 1-4 (scalp).)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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