Status:
UNKNOWN
Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System
Lead Sponsor:
University of Aberdeen
Collaborating Sponsors:
NHS Grampian
Softcell Medical Ltd
Conditions:
Acute Compartment Syndrome
Eligibility:
All Genders
16-59 years
Phase:
NA
Brief Summary
Acute Compartment Syndrome (ACS) can occur when there is a gradual reduction in the blood supply to injured limbs, most commonly after fractures or crush injuries. If ACS is not diagnosed early enough...
Detailed Description
Patients who are admitted to an orthopaedic trauma unit or intensive care unit with fractures or crush injuries and who are at risk of developing Acute Compartment Syndrome (ACS) are eligible for the ...
Eligibility Criteria
Inclusion
- Orthopaedic Limb injuries that are at increased risk of developing ACS. In particular the following injuries will have been sustained to permit inclusion:
- Tibial diaphyseal fractures
- High energy injuries around the knee (such as dislocations of the knee, fracture dislocations of the knee or complex fractures involving the proximal tibia e.g. Shatzker IV - VI types).
- Forearm diaphyseal fractures
- High energy injuries around the elbow resulting in complex fracture dislocations.
- Significant crush injuries to the lower or upper limbs, including thigh, lower leg, upper arm and forearm, where compartment syndrome is suspected, in the presence or absence of a fracture.
- Male and female participants will be a minimum of sixteen years of age and under 60 years of age.
- Participants should be able to understand spoken and written English.
- Able and willing to give verbal agreement or informed consent to participate.
Exclusion
- Patients who have evidence of previous ACS in the affected limb are not eligible.
- Patients who were, prior to injury, receiving anticoagulant therapy (with the exception of aspirin or other anti-platelet aggregation drugs) for pre-existing conditions should also be excluded from the study.
- Patients who have other illnesses/disease processes for whom the study could be detrimental will be excluded from the study (for example those with blood clotting disorders, current leukaemia, currently chemotherapy treatment, visible signs of peripheral vascular disease).
- Eligible patients will have recently sustained a serious injury - in these circumstances, pregnancy testing is challenging and not routinely done in clinical practice. We will exclude patients who declare that they are pregnant.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04725604
Start Date
March 1 2024
End Date
July 28 2025
Last Update
December 19 2023
Active Locations (7)
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1
NHS Grampian
Aberdeen, Aberdeen City, United Kingdom, AB15 6RE
2
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
3
NHS Tayside
Dundee, United Kingdom, DD3 8EA
4
NHS Lothian
Edinburgh, United Kingdom, EH1 3EG