Study Results
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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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-03-15
2025-12-01
Brief Summary
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Detailed Description
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Continuous glucose monitoring allows for a minimally invasive real-time remote glycemia control, yet it has not been applied in an emergency surgery setting. Intraoperative glycemia monitoring would allow to determine the effect of specific interventions during a surgical procedure that may provoke hyperglycaemia.
CLUE is a single-centre prospective observational study held in an academic tertiary medical centre in Poland. Adult patients qualified for an emergency laparotomy for peritonitis in University Clinical Centre (UCC) Division of Oncological, Endocrine and General Surgery, with class ≥ III wounds according to Centers for Disease Control and Prevention (CDC) classification, will be eligible for the CLUE trial. Patients who will be unable or will refuse to express informed consent will be excluded. Patients will be co-enrolled in PRISTINE randomized health services study that aims to compare the effectiveness of negative pressure wound therapy (NPWT) and primary closure (PC) in surgical site infection prevention.
On admission day, patients will have a Dexcom G6 system placed on the outer part of the upper arm. Patients will undergo standard surgical procedures and perioperative care. Patients will be randomized to NPWT or PC according to PRISTINE protocol. Glycemia will be continuously monitored for 10 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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CGM pre-, intra- and postoperatively
Patients will have a Dexcom G6 system placed on admission on outer part of the arm, glycaemia will be monitored for 10 consecutive days
CGM (Dexcom G6)
Dexcom G6 system consists of a transmitter and sensor that measure interstitial glycaemia every 5 minutes. Measurements are transmitted via Bluetooth to a compatible device, that uploads the data on a virtual drive. This allows for remote real-time glycaemia monitoring on another device.
Interventions
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CGM (Dexcom G6)
Dexcom G6 system consists of a transmitter and sensor that measure interstitial glycaemia every 5 minutes. Measurements are transmitted via Bluetooth to a compatible device, that uploads the data on a virtual drive. This allows for remote real-time glycaemia monitoring on another device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* written informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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Principal Investigators
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Piotr Spychalski, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
MUG Division of General Surgery
Katarzyna Polomska
Role: PRINCIPAL_INVESTIGATOR
Medical University of Gdansk (MUG)
Jaroslaw Kobiela, Prof.
Role: PRINCIPAL_INVESTIGATOR
MUG Division of General Surgery
Locations
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UCC Division of Oncological, Transplant and General Surgery
Gdansk, Pomeranian Voivodeship, Poland
Countries
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Central Contacts
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Other Identifiers
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420/2
Identifier Type: -
Identifier Source: org_study_id
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