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

April 9, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall feasibility and clinical utility of infrared thermography
Time Frame: Postoperative days 2-4 and day 7 (Mohs); day 7 and day 14 (trunk/extremities); postoperative weeks 1-4 (scalp).
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Annemiek Leeman, Prof. Dr., UZLeuven, Department of Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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