Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-10-22

Brief Summary

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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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Detailed Description

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Conditions

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Abdominal Surgery Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SeaPatch

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

Group Type EXPERIMENTAL

SEAPatch

Intervention Type DEVICE

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

Interventions

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SEAPatch

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No