Abdominal Surgery PatientsSEASLUGNCT07055308
Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing
A study testing SEAPatch in people with Abdominal Surgery Patients, run by Stichting IMEC-NL at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery Patients
- What is being tested?
- SEAPatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Oct 2023to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SEAPatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEAPatchDevice
Daily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| SeaPatch | Experimental | Daily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital. Receives: Device: SEAPatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin temperature around the surgical incision.
Skin Temperature in degrees Celsius at multiple locations around the incision.
Measured: 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.
Measured: 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.
Measured: From day 1 post-operative up to 14 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start16 Oct 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Surgery PatientsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting IMEC-NL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055308
- Sponsor's protocol ID
- IM-NL-STUDY-2022-0028
- Other IDs
- CIV-23-06-043226
- Acronym
- SEASLUG
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisensory Patch to Measure Healthy and Abnormal Surgical Incision Healing
- ClinicalTrials.gov ID
- NCT07055308
- Acronym / sponsor ID
- SEASLUG / IM-NL-STUDY-2022-0028
- Conditions
- Abdominal Surgery Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Stichting IMEC-NLUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 8 Jul 2025 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SeaPatch | Experimental | Device: SEAPatchDaily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| SEAPatchDaily measurement with multisensory patch from day 1 post-surgery maximally up to the day of discharge from hospital. | Device | SeaPatch |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEAPatch in people with Abdominal Surgery Patients, run by Stichting IMEC-NL 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature around the surgical incision. (time frame: From day 1 post-operative up to 14 days post-operative). The study lists 3 primary outcomes in all. 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 8 Jul 2025.