Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001663842
Ethics application status
Approved
Date submitted
26/10/2021
Date registered
3/12/2021
Date last updated
8/11/2022
Date data sharing statement initially provided
3/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Forearm skin flap for monitoring of acute transplant rejection in children and adolescents
Scientific title
Safety, feasibility, and acceptability of liver & small bowel transplant using a vascularised composite skin flap (sentinel flap) for monitoring of acute rejection in children and adolescents
Secondary ID [1] 305652 0
Nil known
Universal Trial Number (UTN)
U1111-1270-8626
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
liver transplant 324111 0
small bowel transplant 324112 0
acute transplant rejection 324308 0
Condition category
Condition code
Surgery 321597 321597 0 0
Surgical techniques
Inflammatory and Immune System 321797 321797 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 321798 321798 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the same time as receiving their bowel or liver transplant, study participants will receive a transplant of skin from the same donor as their solid organ.

This intervention is performed surgically and requires standard surgical techniques performed in a standard operating theatre.

Surgery requires retrieval of a skin flap from the organ donor followed by transplantation of the skin flap into the recipient.

Both surgeries are performed by members of the Plastic & Maxillofacial Surgery department of the Royal Children's Hospital, Melbourne or suitably trained delegated representatives and will only be performed once. Donor and recipient surgery are conducted alongside surgery to perform solid organ transplantation. Additional anaesthetic is therefore not required.

No additional investigations or interventions are required prior to surgery.

Surgery to retrieve the skin flap from the donor takes approximately 45 minutes and will occur simultaneously with the solid organ donation (which takes approximately 4-5 hours).

Skin will be elevated from the volar forearm along with its artery and vein. The is a standard procedure (called a radial forearm flap) regularly performed by plastic surgeons. The radial forearm flap will be divided from its blood supply at the same time as the liver or small bowel is removed. The skin will then be stored in a damp gauze, inside a water-proof bag, and placed on ice along with the bowel or liver for transport.

The skin and organ are transported to the theatre suite of The Royal Children's Hospital, Melbourne where surgery to perform the transplant will be undertaken.

The surgery to transplant the liver or small bowel usually takes 6 hours. The radial forearm flap will be joined to an artery and vein in the patient's forearm whilst the liver or small bowel is being transplanted. This procedure will take approximately 90 minutes but may not increase total operative time if performed concurrently.

Postoperative care is delivered in accordance with standards for the solid organ transplantation. Postoperative medication, length of stay, and level of care varies and is determined by the type of solid organ transplant and the underlying cause of organ failure.

The sentinel flap will not require any change to routine postoperative care other than clinical assessment by trained nursing staff every hour for 24 hours, then 4 hourly thereafter until discharge.
Intervention code [1] 322044 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329362 0
Sentinel flap survival.
Assessed by clinical examination.
Timepoint [1] 329362 0
Assessment performed as per protocol
Week 0 to week 3 post-surgery: Daily
Week 3 to week 7 post-surgery: Weekly
Week 8 to week 52 post-surgery: Monthly
Week 52 post-surgery onwards: Assessments performed when patient attends for clinical review of solid organ transplant (determined by clinical status of solid organ transplant)

Assessment performed outside of protocol
At all other times of non-protocol patient contact with bowel or liver transplant services.
Primary outcome [2] 329563 0
Adverse events related to the sentinel flap procedure assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0).
Examples may include:
Postoperative haemorrhage
Skin Infection
Skin ulceration
Soft tissue necrosis of the upper limb

Events will be grade as 1 (mild), 2 (moderate), 3 (severe), 4 (life threatening), 5 (death)
Timepoint [2] 329563 0
Recorded at the time of adverse event occurrence and monitored from the time of surgery until 52 weeks following transplant.
Secondary outcome [1] 402307 0
Organ retrieval team satisfaction
Satisfaction with surgical efficiency, communication, and overall satisfaction will be assessed using a 5-point Likert scale.
Timepoint [1] 402307 0
Time of surgery
Secondary outcome [2] 402991 0
Organ transplantation team satisfaction
Satisfaction with surgical efficiency, communication, and overall satisfaction will be assessed using a 5-point Likert scale.
Timepoint [2] 402991 0
Time of surgery
Secondary outcome [3] 402992 0
Recipient satisfaction
Satisfaction with flap position, flap appearance, and overall satisfaction will be assessed using a 5-point Likert scale.
Timepoint [3] 402992 0
1 month following surgery
6 months following surgery
12 months following surgery

Eligibility
Key inclusion criteria
Each participant must meet all the following criteria to be enrolled in this trial:
- Is 18 years of age or younger at the time of enrolment
- Requires organ replacement therapy / organ support to the degree that prior specialist assessment has determined the need for liver, bowel, or multivisceral transplantation.
- Has provided signed and dated consent through a legally acceptable representative, obtained outside of this study, to proceed with the recommended solid organ transplant (SOT).
- Have a legally acceptable representative capable of understanding the informed consent document and provide consent to this study on the participant’s behalf.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the trial:
- Donor or recipient intraoperative physiologic instability
Relative contraindications to be considered on an individual basis by the trial management group at the point of enrolment.
- Presence of donor specific antigen (DSA) exceeding a mean fluorescence index of 5000
- Planned ABO mismatched transplantation
- Other high risk immunologic features identified by the study group

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Not required

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20931 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 35745 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 310009 0
Hospital
Name [1] 310009 0
The Royal Children's Hospital, Melbourne
Country [1] 310009 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital, Melbourne
Address
50 Flemington Road, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 311064 0
Charities/Societies/Foundations
Name [1] 311064 0
Murdoch Childrens Research Institute
Address [1] 311064 0
50 Flemington Road, Parkville, VIC 3052
Country [1] 311064 0
Australia
Secondary sponsor category [2] 311065 0
University
Name [2] 311065 0
University of Melbourne
Address [2] 311065 0
Department of Paediatrics,
Reception Level 2, West Building
The Royal Children's Hospital,
50 Flemington Road, Parkville, VIC 3052
Parkville VIC 3010
Country [2] 311065 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309719 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 309719 0
Ethics committee country [1] 309719 0
Australia
Date submitted for ethics approval [1] 309719 0
16/09/2021
Approval date [1] 309719 0
15/11/2021
Ethics approval number [1] 309719 0
HREC/75649/RCHM-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115154 0
Mr Daniel Wilks
Address 115154 0
The Royal Children's Hospital, 50 Flemington Road, Parkville, VIC 3052
Country 115154 0
Australia
Phone 115154 0
+61393456076
Fax 115154 0
Email 115154 0
[email protected]
Contact person for public queries
Name 115155 0
Daniel Wilks
Address 115155 0
The Royal Children's Hospital, 50 Flemington Road, Parkville, VIC 3052
Country 115155 0
Australia
Phone 115155 0
+61393456076
Fax 115155 0
Email 115155 0
[email protected]
Contact person for scientific queries
Name 115156 0
Daniel Wilks
Address 115156 0
The Royal Children's Hospital, 50 Flemington Road, Parkville, VIC 3052
Country 115156 0
Australia
Phone 115156 0
+61393456076
Fax 115156 0
Email 115156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data
When will data be available (start and end dates)?
Beginning 6 months following publication
End 15 years following publication
Available to whom?
Recognised research institutions whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept the conditions for access
Available for what types of analyses?
Analyses required to achieve the aims in the approved proposal
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13759Study protocol  [email protected]
13760Informed consent form  [email protected]



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.