Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing

Abdominal surgical incisions often lead to superficial surgical site infection (SSI). SSI is characterized by heat (calor), pain (dolor), redness (rubor), and swelling (tumor). The aim of this study is to measure calor, rubor and tumor with electronic sensors. Therefore, a multisensory patch is proposed which measures the tissue surrounding the incision once per day.

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Key information

Conditions

Abdominal Surgery Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost Limburg

Genk, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The subject requires acute abdominal surgery due to perforation of the intestinal tractus (i.e., contamination upfront).
The subject's incision is closed with either sutures or staples (by primary intention).
The subject is 18 years or older.
The subject can understand the patient information/ consent form and is capable of making his/her own decision.
The subject is accompanied by an acquaintance who can give the second consent.

Exclusion criteria

The subject has a known allergy to (silicon) adhesives.
The subject states to be pregnant or planning to become pregnant.
The subject receives medication that is contraindicated to excessive light exposure (e.g. Tetracylines, Doxycycline, Phenothiazines, Dacarbazine, Ketoprofen, Lomefloxacin). This criterion will be implemented in order to exclude the possibility of local skin irritation from prolonged irradiation by LED-light.
The subject has an implantable device with a battery (i.e. pacemaker or other active implant).
The subject has tattoos on the abdomen.

Treatment and study plan

SEAPatch

Device

Daily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital.

Primary outcomes

Skin temperature around the surgical incision.

Time frame: From day 1 post-operative up to 14 days post-operative

Skin Temperature in degrees Celsius at multiple locations around the incision.
Bioimpedance around the incision.

Time frame: From day 1 post-operative up to 14 days post-operative

Bioimpedance in resistance and reactance at multiple locations around the incision.
PPG around the surgical incision.

Time frame: From day 1 post-operative up to 14 days post-operative

Reflective PPG in 3 different wavelengths around the surgical incision.

Sponsors and collaborators

Lead sponsor

Stichting IMEC-NL

Other

Registry information

Acronym: SEASLUG

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 8, 2025
Registry last updated: Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed