Real-time Soft Tissue Assessment Using a Technologically Advanced pH Monitoring System

Launched by UNIVERSITY OF ABERDEEN · Jan 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose Acute Compartment Syndrome (ACS), which can happen when blood flow to an injured limb is reduced, often after a fracture or crush injury. Early detection of ACS is crucial because if it is not diagnosed in time, it can lead to serious damage to muscles and tissues. The researchers will use a special pH monitoring system to measure the acidity in the injured muscle, which may indicate a lack of blood flow. They will compare the results from this new method with the current ways doctors assess ACS.

To participate in this study, individuals must be aged 16 to 60 and have specific types of severe limb injuries that put them at risk for developing ACS. Participants will have a small pH probe placed near their injury to collect data over three days, but doctors will make treatment decisions based on existing methods, not the pH data. After six months, the researchers will check to see if any cases of ACS were missed. This study aims to help detect ACS earlier, which could lead to better long-term outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Orthopaedic Limb injuries that are at increased risk of developing ACS. In particular the following injuries will have been sustained to permit inclusion:
• • 1. Tibial diaphyseal fractures
• • 2. 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).
• • 3. Forearm diaphyseal fractures
• • 4. High energy injuries around the elbow resulting in complex fracture dislocations.
• • 5. 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 Criteria:
• • 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.