Free Tissue FlapsEarly Phase 1NCT02604069
Detection of Flap Ischemia Using Interstitial Glucose Monitor
A Early Phase 1 study testing Continuous Glucose Monitor in people with Free Tissue Flaps, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Free Tissue Flaps
- What is being tested?
- Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Feb 2016
- Phase
- Early Phase 1
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are undergoing unilateral or bilateral breast reconstruction with free flap including DIEP flaps at Hamilton Health Sciences, starting from the date of ethics approval.
Who cannot join
- Patients with diabetes (on oral antiglycemic medications or insulin-dependent)
- Patients who are on immunosuppressive medication
- Patients undergoing breast reconstruction involving expanders or implants
- Patients with active infections
Trial locations and contacts
1 site in 1 country.
Edward Liu, MD contact
Canada1 site
Juravinski Hospital
Hamilton, Ontario, L8V 1C3
Edward Liu, MD, Edward.Liu@medportal.ca
Edward Liu, MD
About this study
Official title: Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this study, the investigators aim to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.
Read the detailed description
Background:
Breast reconstruction involving microvascular free tissue transfer is a major, labour-intensive operation that provides numerous benefits for patients' psychosocial function and well-being.
Flap failure, though rare, is a devastating complication and leads to serious morbidities. It can occur in the first 24-72 hours after the operation. However, if ischemia is detected earlier, the chances for operative salvage are better. Unfortunately, the current monitoring process remains mostly subjective.
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival.
Purpose:
The overall objective of this clinical pilot study is to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.
Methods:
In this pilot cohort study, the investigators aim to prospectively include 30 free flaps in total from 10-20 patients undergoing DIEP-based breast reconstruction by one surgeon at Juravinski Hospital. Patients will be recruited at the pre-operative consultation. The transcutaneous sensor of the CGM device will be inserted into the subcutaneous layer of the flap upon completion of surgery, while an additional sensor will be placed on the patient's thigh as control. These devices are blinded and will start recording the flap's interstitial glucose levels. The patient will be admitted and the flap will be assessed clinically as per protocol. On-call residents will be given a data collection sheet to document the exact time they were alerted about a flap, the clinical finding, and the subsequent decision made. Once an endpoint has been reached for a flap, the CGM sensor will be removed and its data extracted.
Data Analysis:
The timing of occurrence of low interstitial glucose levels and rapid glucose level decline will be analyzed with the timing of clinical concerns raised about the flap. The systemic glucose level will be used as a control for the flap glucose level. The investigators aim to analyze the temporal correlation between interstitial glucose measurements and clinical findings of the flap's vascular status (eg. vessel occlusion, ischemia). Statistical analysis will be done with assistance by a biostatistician.
- Conditions
- Free Tissue Flaps
- Being tested
- Continuous Glucose Monitor
- Keywords
- Breast reconstruction, Breast cancer, Microsurgery, Continuous flap monitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitorDevice
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Application of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring Receives: Device: Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporal correlation between interstitial glucose measurements and flap ischemia
Measured: within 6 days after surgery
Secondary outcomes (3)
Incidence of minor side effects related to device
Measured: within 6 days after surgery
Incidence of major adverse effects related to the device
Measured: within 6 days after surgery
Incidences of technical issues related to the device
Measured: within 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Free Tissue FlapsStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Thoma, Achilleas, Jiayi Hu, Matthew McRae
- Responsible party
- Principal investigator, Ronen Avram, Hamilton Health Sciences Corporation
- Investigators
- Ronen Avram, MD, Principal investigator, Associate Professor, Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604069
- Sponsor's protocol ID
- CGM-2015-10
- Status last verified
- Nov 2015
- First submitted
- 11 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Monitoring of Tissue Perfusion in Microvascular Free Flaps Using Continuous Interstitial Glucose Monitoring Device: A Pilot Study
- ClinicalTrials.gov ID
- NCT02604069
- Acronym / sponsor ID
- CGM-2015-10
- Conditions
- Free Tissue Flaps
- Keywords
- Breast reconstruction, Breast cancer, Microsurgery, Continuous flap monitor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Thoma, Achilleas, Jiayi Hu, Matthew McRae
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- 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.
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival. In this study, the investigators aim to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.
Detailed description
Background:
Breast reconstruction involving microvascular free tissue transfer is a major, labour-intensive operation that provides numerous benefits for patients' psychosocial function and well-being.
Flap failure, though rare, is a devastating complication and leads to serious morbidities. It can occur in the first 24-72 hours after the operation. However, if ischemia is detected earlier, the chances for operative salvage are better. Unfortunately, the current monitoring process remains mostly subjective.
A simple device that objectively assesses flap perfusion - either as a stand-alone tool or an adjunct to the current monitoring method - would be a tremendous improvement in detection of early postoperative flap ischemia and, in turn, increase flap salvage and survival.
Purpose:
The overall objective of this clinical pilot study is to examine the accuracy and reliability of measuring interstitial glucose levels using Continuous Glucose Monitoring (CGM) technology as an objective method of detecting postoperative flap tissue ischemia in patients undergoing free flap-based reconstructive surgery.
Methods:
In this pilot cohort study, the investigators aim to prospectively include 30 free flaps in total from 10-20 patients undergoing DIEP-based breast reconstruction by one surgeon at Juravinski Hospital. Patients will be recruited at the pre-operative consultation. The transcutaneous sensor of the CGM device will be inserted into the subcutaneous layer of the flap upon completion of surgery, while an additional sensor will be placed on the patient's thigh as control. These devices are blinded and will start recording the flap's interstitial glucose levels. The patient will be admitted and the flap will be assessed clinically as per protocol. On-call residents will be given a data collection sheet to document the exact time they were alerted about a flap, the clinical finding, and the subsequent decision made. Once an endpoint has been reached for a flap, the CGM sensor will be removed and its data extracted.
Data Analysis:
The timing of occurrence of low interstitial glucose levels and rapid glucose level decline will be analyzed with the timing of clinical concerns raised about the flap. The systemic glucose level will be used as a control for the flap glucose level. The investigators aim to analyze the temporal correlation between interstitial glucose measurements and clinical findings of the flap's vascular status (eg. vessel occlusion, ischemia). Statistical analysis will be done with assistance by a biostatistician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor | Experimental | Device: Continuous Glucose MonitorApplication of CGM for 6 days following free flap reconstruction in conjunction with clinical monitoring |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are undergoing unilateral or bilateral breast reconstruction with free flap including DIEP flaps at Hamilton Health Sciences, starting from the date of ethics approval.
Key exclusion criteria (4 listed)
- Patients with diabetes (on oral antiglycemic medications or insulin-dependent)
- Patients who are on immunosuppressive medication
- Patients undergoing breast reconstruction involving expanders or implants
- Patients with active infections
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 |
|---|---|---|
| Continuous Glucose Monitor | Device | Continuous Glucose Monitor |
Primary outcome
Temporal correlation between interstitial glucose measurements and flap ischemia
Time frame: within 6 days after surgery
3 secondary outcomes
Incidence of minor side effects related to device
Time frame: within 6 days after surgery
Incidence of major adverse effects related to the device
Time frame: within 6 days after surgery
Incidences of technical issues related to the device
Time frame: within 6 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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.
Edward Liu, MD contact
Ronen Avram, MD principal investigator
Associate Professor, Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Continuous Glucose Monitor in people with Free Tissue Flaps, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2015. 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 Canada. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Liu, MD (Edward.Liu@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporal correlation between interstitial glucose measurements and flap ischemia (time frame: within 6 days after surgery). 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 13 Nov 2015.