Wound HealingTHERMSNCT07524062
The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery
A study testing Infrared thermography in people with Wound Healing and Surgical Wound Infection, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Surgical Wound Infection, Postoperative Complications
- What is being tested?
- Infrared thermography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jun 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven, Department of Dermatology
Leuven, Vlaams Brabant, 3000
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Healing, Surgical Wound Infection, Postoperative Complications, Skin Neoplasms, Skin Transplantation
- Being tested
- Infrared thermography
- Keywords
- Infrared thermography, Surgical wound healing, Dermatosurgery, Thermal imaging, Wound complications
- Medical subject headings
- Surgical Wound Infection, Postoperative Complications, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared thermographyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Infrared thermography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: Postoperative days 2-4 and day 7 (Mohs); day 7 and day 14 (trunk/extremities); postoperative weeks 1-4 (scalp).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Jun 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemiek Leeman, Prof. Dr., Principal investigator, UZLeuven, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524062
- Sponsor's protocol ID
- S71301 _ CIV-25-12-055874
- Acronym
- THERMS
- Status last verified
- Mar 2026
- First submitted
- 1 Apr 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Infrared Thermography in the Prediction of Skin Healing in Surgery THERMS: THermography for Evaluation of Recovery and Monitoring of Surgical Wounds
- ClinicalTrials.gov ID
- NCT07524062
- Acronym / sponsor ID
- THERMS / S71301 _ CIV-25-12-055874
- Conditions
- Wound Healing, Surgical Wound Infection, Postoperative Complications, Skin Neoplasms, Skin Transplantation
- Keywords
- Infrared thermography, Surgical wound healing, Dermatosurgery, Thermal imaging, Wound complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermography Monitoring Arm | Experimental | Device: Infrared thermographyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared thermographyParticipants 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. | Device | Thermography Monitoring Arm |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annemiek Leeman, Prof. Dr. principal investigator
UZLeuven, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared thermography in people with Wound Healing and Surgical Wound Infection, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemiek Leeman, Prof. Dr. (0032 016 33 79 50, annemiek.leeman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.