Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001344785
Ethics application status
Approved
Date submitted
3/12/2013
Date registered
9/12/2013
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The physiological effect of dangling on lower limb free flap perfusion
Scientific title
The physiological effect of dangling on patients undergoing lower limb free flap perfusion
Secondary ID [1] 283683 0
Nil known
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Free flap perfusion 290647 0
Condition category
Condition code
Musculoskeletal 291026 291026 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288385 0
Treatment: Other
Comparator / control treatment
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 (intervention), whilst group 2 will begin dangling on day 7 (control). All patients will have their flap monitored by clinical assessment, implantable venous doppler and transcutaneous oxygen saturation (St02%).
Control group
Active

Outcomes
Primary outcome [1] 291014 0
mean hospital length of stay for index admission (days)
Timepoint [1] 291014 0
At hospital discharge
Primary outcome [2] 291046 0
Average cost of index hospital admission ($AUD)
Timepoint [2] 291046 0
At hospital discharge
Secondary outcome [1] 305843 0
Free flap monitoring based on clinical assessment - color, temperature, turgor, capillary refill
Timepoint [1] 305843 0
daily until discharge from hospital
Secondary outcome [2] 305887 0
Analysis of the blood supply to the flap by implantable venous doppler
Timepoint [2] 305887 0
daily until discharge from hospital
Secondary outcome [3] 305888 0
Analysis of the blood supply to the flap by transcutaneous oxygen saturation measurement (St02%)
Timepoint [3] 305888 0
daily until discharge from hospital

Eligibility
Key inclusion criteria
male or female, age >18 years
lower limb extremity free flap reconstruction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
return to theatre for flap salvage
those who are unable or unwilling to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
consecutive patients undergoing lower limb free flap reconstruction will be recruited from the Plastic & Reconstructive Surgery Department at Royal Adelaide Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prospective randomized controlled trial - randomization will take place immediately following recruitment. Randomisation method – simple randomization
Computer generated random numbers will be sealed in sequentially numbered envelopes. Group allocation will be independent of time, place, and person delivering the treatment.
Group 1. Dangling to commence on day 3
Group 2. Dangling to commence on day 7
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In order for the study to have 80% power to detect a difference in LOS between the two flap groups of 4 days, assuming a SD of 5 days and a two-tailed alpha of 0.05, 26 participants per group are required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1786 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7601 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288369 0
Hospital
Name [1] 288369 0
Royal Adelaide Hospital
Country [1] 288369 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Department of Plastic Surgery
Level 5, North Wing Link, North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 287074 0
Individual
Name [1] 287074 0
Raakhi Mistry
Address [1] 287074 0
Department of Plastic Surgery
Level 5, North Wing Link, North Terrace
Adelaide SA 5000
Country [1] 287074 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290251 0
Royal Adelaide Hospital
Ethics committee address [1] 290251 0
Department of Plastic Surgery
Level 5, North Wing Link, North Terrace
Adelaide SA 5000
Ethics committee country [1] 290251 0
Australia
Date submitted for ethics approval [1] 290251 0
Approval date [1] 290251 0
14/11/2013
Ethics approval number [1] 290251 0
131024

Summary
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.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 44686 0
Dr Raakhi Mistry
Address 44686 0
Department of Plastic Surgery
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country 44686 0
Australia
Phone 44686 0
+61(0)420970408
Fax 44686 0
Email 44686 0
raakhimistry@gmail.com
Contact person for public queries
Name 44687 0
Dr Raakhi Mistry
Address 44687 0
Department of Plastic Surgery
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country 44687 0
Australia
Phone 44687 0
+61(0)420970408
Fax 44687 0
Email 44687 0
raakhimistry@gmail.com
Contact person for scientific queries
Name 44688 0
Dr Raakhi Mistry
Address 44688 0
Department of Plastic Surgery
Royal Adelaide Hospital
North Terrace
Adelaide, SA
5000
Country 44688 0
Australia
Phone 44688 0
+61(0)420970408
Fax 44688 0
Email 44688 0
raakhimistry@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.