None listed
Conditions
Brief summary
INTRODUCTION Dependency of the lower limb following free flap reconstruction needs to be gradually introduced due to the risk of edema and consequent effects on flap microcirculation. It is well established that these flaps must undergo graduated periods of wrapping and dangling before progressing to full dependency. Objective evidence for initiation of post-operative dangling following lower limb free flap reconstruction is limited and there is significant variability in the protocols of individual centres and surgeons. OBJECTIVE The goal of this study is to determine the physiological effect of dangling on lower limb free flap perfusion in order to determine an evidence-based protocol. METHODS Randomised controlled trial of patients from Royal Adelaide Hospital who have undergone lower limb free flap reconstruction. Group 1 will begin dangling on day 3, whilst group 2 will begin dangling on day 7. All patients will have their flap monitored by clinical assessment, implantable venous doppler and transcutaneous oxygen saturation (St02%). CONCLUSION The results of this study will be statistically analysed and summarised, will be presented at a plastic surgery conference, and will be submitted for publication in a peer-reviewed journal.
Interventions
Randomised controlled trial of patients from Royal Adelaide Hospital who have undergone lower limb free flap reconstruction. Group 1 (intervention) will begin dangling on day 3, whilst group 2 (control) will begin dangling on day 7. All patients will have their flap monitored by clinical assessment, implantable venous doppler and transcutaneous oxygen saturation (St02%).
The dangling protocol involves wrapping the lower limb with an elasticated compression bandage extending from the toes to th
Randomised controlled trial of patients from Royal Adelaide Hospital who have undergone lower limb free flap reconstruction. Group 1 (intervention) will begin dangling on day 3, whilst group 2 (control) will begin dangling on day 7. All patients will have their flap monitored by clinical assessment, implantable venous doppler and transcutaneous oxygen saturation (St02%). The dangling protocol involves wrapping the lower limb with an elasticated compression bandage extending from the toes to the knee. The patient will then be seated on the edge of the bed with your knee joint bent at 90 degrees and the heel dangled unsupported. The lower limb will be dangled for 5 minutes three times per day on the first day of the protocol. The duration of dangling will be doubled every day for the next five days. Before, during and after the dangling process, we will analyse the blood supply of the flap using clinical assessment, venous Doppler and tissue oximetry.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
male or female, age >18 years lower limb extremity free flap reconstruction
Exclusion criteria
return to theatre for flap salvage those who are unable or unwilling to give informed consent
Outcome results
None listed