Microenvironment in Patients Undergoing Non-traumatic Amputation
ConditionLower Limb Amputation Above Knee
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
The microenvironment of the amputation stump in patients undergoing non-traumatic transfemoral amputation will be investigated with a combination of microdialysis and tissue sampling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Cognitive ability to provide informed consent
Scheduled for transfemoral amputation at Aarhus University Hospital
Disqualifiers
Non-vascular indication of amputation
Already amputated on the contralateral leg
Insufficient flap perfusion
Allergic or sensitivity to silver or acrylic adhesives
Trial design
Design model
Parallel
Treatments tested in this trial
ciNPWT
DeviceClosed incision negative pressure wound therapy
SSD
Other interventionStandard stump dressing
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: ciNPWTActive comparator 1 intervention
Group B: SSDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Ischemia
Concentration of ischemic metabolites: Glucose, Lactate, Pyruvate and Glycerol
Time frame
Within 72 hours postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Aarhus University Hospital
Sponsor institution
Source ClinicalTrials.gov