Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing

NCT07055308 | Completed

• 2 other identifiers: IM-NL-STUDY-2022-0028CIV-23-06-043226
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Surgery Patients

Outcome Measures

Primary Outcomes (3)

• Skin temperature around the surgical incision.

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

  From day 1 post-operative up to 14 days post-operative

• Bioimpedance around the incision.

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

  From day 1 post-operative up to 14 days post-operative

• PPG around the surgical incision.

  Reflective PPG in 3 different wavelengths around the surgical incision.

  From day 1 post-operative up to 14 days post-operative

Study Arms (1)

SeaPatch

EXPERIMENTAL

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

Device: SEAPatch

Interventions

SEAPatch DEVICE

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

SeaPatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stichting IMEC-NL: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Belgium

Location

Study Design

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

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: July 8, 2025
• Study Start: October 16, 2023
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-06

Locations

BE (1)