The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery (THERMS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Surgical Wound Infection; Skin Neoplasms; Wound Healing; Skin Transplantation
• Intervention / Treatment: Device: Infrared thermography

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annemiek Leeman, Prof. Dr.; Phone Number: 0032 016 33 79 50; Email: annemiek.leeman@uzleuven.be
• Study Contact Backup: Name: Sofie Van Kelst, BSc; Phone Number: 0032 016 33 78 64; Email: sofie.vankelst@kuleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZLeuven, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Thermography Monitoring Arm; 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.

Device: Infrared thermography; Participants will undergo non-contact infrared thermography using a handheld thermal imaging device to capture temperature patterns of the surgical wound at predefined postoperative time points. The device is used solely for diagnostic imaging and does not touch the skin or alter wound care. Thermal images are recorded under standardized conditions and analyzed to identify temperature changes that may indicate normal healing or early signs of complications such as infection, delayed healing, or graft failure. This intervention differs from standard clinical follow-up because it adds objective thermal measurements that are not part of routine postoperative assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal pattern changes associated with normal versus abnormal surgical wound healing	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall feasibility and clinical utility of infrared thermography	This outcome assesses the overall feasibility and clinical utility of infrared thermography in postoperative wound monitoring, based on a combined evaluation of image acquisition success, clinician-reported usability, and its contribution to earlier identification of wound abnormalities. A single composite qualitative outcome will be reported.	Postoperative days 2-4 and day 7 (Mohs); day 7 and day 14 (trunk/extremities); postoperative weeks 1-4 (scalp).

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Annemiek Leeman, Prof. Dr., UZLeuven, Department of Dermatology

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Infrared thermography; Wound complications; Surgical wound healing; Thermal imaging; Dermatosurgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Infections; Skin Diseases; Wound Infection; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Skin Neoplasms; Surgical Wound Infection; Postoperative Complications
• Other Study ID Numbers: S71301 _ CIV-25-12-055874

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study collects identifiable thermal images linked to clinical wound outcomes, and secondary use is not foreseen. Data are stored under GDPR protections and are not intended for redistribution.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No