NCT07524062

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Oct 2028

First Submitted

Initial submission to the registry

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

June 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

April 1, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Infrared thermographySurgical wound healingDermatosurgeryThermal imagingWound complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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).

Study Arms (1)

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.

Device: Infrared thermography

Interventions

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.

Thermography Monitoring Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZLeuven, Department of Dermatology

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Surgical Wound InfectionPostoperative ComplicationsSkin Neoplasms

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Annemiek Leeman, Prof. Dr.

    UZLeuven, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemiek Leeman, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 13, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

June 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations