Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000484246
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
4/04/2018
Date last updated
5/09/2022
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Glue in Skin Grafts for Skin Cancer
Scientific title
Determining the Efficacy of Fibrin Glue in Skin grafts for Skin cancer (FiGSS): Open randomised clinical trial
Secondary ID [1] 294343 0
None
Universal Trial Number (UTN)
U1111-1210-9611
Trial acronym
FiGSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin cancer
 307063 0
Skin Graft Failure 307065 0
Condition category
Condition code
Skin 306173 306173 0 0
Other skin conditions
Surgery 306174 306174 0 0
Surgical techniques
Cancer 306330 306330 0 0
Malignant melanoma
Cancer 306331 306331 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Fibrin Glue
Generic Name: Two-Component Fibrin Sealant, Vapour heated and solvent detergent treated
Dose: Dependent on area of skin graft to be treated, in 5mL aliquots
Duration: Administered once, intraoperatively
Mode: Topical, between skin graft and graft bed. Administered by trained general surgeon or plastic/reconstructive surgeon.
Procedure: As per the usual surgical procedure, the patient will usually have a general anaesthetic (sometimes a local anaesthetic) and their skin cancer will be excised as usual and skin graft prepared as usual. Patients will then either have their graft affixed with the fibrin glue or sutures/staples as per the randomisation code. Each procedure is variable time length mostly depending on the number of lesions to be excised but usually each lesion takes 30-40 minutes.
To ensure fidelity patients will only be operated on by two surgeons (one general one plastic) who are both trained in use of glue.

Fibrin glue was initially used for haemostatic purposes (to stop bleeding intraoperatively), because when it is introduced to a wound with Thrombin, Factor XIII and Calcium it mimics the final events in the clotting cascade, turning fibrinogen into fibrin. Originally spun from plasma intraoperatively, commercial preparations are now available which produce high concentrations of fibrin and can be used as an adhesive. Fibrin glue has been investigated for use in skin grafts relating to burns and shown no inferiority to staples/sutures in terms of wound closure. Specifically, fibrin glue adheres the entire surface of the graft to the site and significantly reduces the formation of haematoma or seroma immediately post-op which commonly results in graft failure.
Intervention code [1] 300648 0
Treatment: Surgery
Comparator / control treatment
Comparator is traditional method of skin graft affixation i.e. sutures or staples. This is not based upon a specific guideline but rather widely accepted practice.
Control group
Active

Outcomes
Primary outcome [1] 305183 0
Graft take (percentage) assessed clinically and confirmed by independent clinicians
Timepoint [1] 305183 0
one month postoperative
Primary outcome [2] 305184 0
Haematoma or Seroma Formation (Yes/No) assessed clinically and confirmed by independent clinicians
Timepoint [2] 305184 0
all participants will be assessed at both one week and one month post operatively
Secondary outcome [1] 344445 0
Pain score (1-10) patient reported
Timepoint [1] 344445 0
one week and one month post operatively
Secondary outcome [2] 344446 0
Operative time (minutes) from hospital records (nursing reported start and finish times)
Timepoint [2] 344446 0
Within the one hour post completion of operation

Eligibility
Key inclusion criteria
a) Will be undergoing surgery at one of the trial centres
b) Have any histological type of skin cancer
c) Age greater than or equal to 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Adverse reaction to the product (Fibrin Glue)
b) Hypersensitivity to bovine protein
c) Skin grafts on digits or genitalia
d) Pregnancy
e) Not cognitively intact to consent to participation
f) Known immunodeficiency (HIV, Leukemia, etc), or haemolytic anaemia
g) Chronic malnourishment

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A sequence of 350 random numbers will be created. The outcome is transferred to a hardcopy with two columns. The left column indicates sequential order (1-350) and the right column contains the random number. The random numbers will be allocated in blocks to ensure equal numbers in each arm of the trial, and the block size will be randomised. The random numbers will be transformed to the letter F (for fibrin glue) or S (for staples/sutures) and thus creating a third column on the hardcopy. This hardcopy is labelled “randomisation code – version A”. A copy of this code will be kept in the event of an adverse event.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A two tailed analysis assuming a power of 0.80 and alpha of 0.05 gave 334 patients in total with 167 in each group. It would likely take approximately one to two years to recruit enough patients for this study. Sample size was determined by power testing with similar papers, one of which compared approximately 300 cases of split skin graft. In this paper at day 28 approximately 68% of participants had 100% take of skin graft in the group using sutures or staples rather than fibrin glue and a 10% difference was considered significant. An estimate of graft take in the general population patients would be drawn from was roughly estimated as 50% and a clinically significant difference was determined to be 15% for this study.
Graft take will be compared based on review at 1 month post operatively, including photographic data and reported wound healing and graft take. Groups will be compared using a two proportion z-test. A sub group analysis on the impact of vascular risk factors will be performed, as well as on haematoma and seroma formation, although the study is not powered for this analysis.
Data will be analysed using statistical software SPSS 22. Demographic data will be presented as percentages. Continuous variables will be tested for normality and based on the outcome of the test, parametric or non-parametric analyses of the data will be undertaken. Z-test analysis to compare two proportions will be used for analysis of graft take. A p value of <0.05 will be considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/04/2018
Actual
18/05/2018
Date of last participant enrolment
Anticipated
6/11/2022
Actual
Date of last data collection
Anticipated
11/12/2022
Actual
Sample size
Target
334
Accrual to date
89
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10388 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 10389 0
Townsville Day Surgery - Townsville
Recruitment hospital [3] 10390 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 22070 0
4814 - Douglas
Recruitment postcode(s) [2] 22071 0
4810 - Townsville
Recruitment postcode(s) [3] 22072 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 298987 0
Hospital
Name [1] 298987 0
The Townsville Hospital
Country [1] 298987 0
Australia
Primary sponsor type
Individual
Name
Ekta Paw
Address
Surgical Services Department
The Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 298210 0
University
Name [1] 298210 0
James Cook University
Address [1] 298210 0
1 James Cook Dr
Douglas QLD 4811
Country [1] 298210 0
Australia
Secondary sponsor category [2] 298228 0
Hospital
Name [2] 298228 0
The Townsville Hospital
Address [2] 298228 0
100 Angus Smith Dr
Douglas QLD 4814
Country [2] 298228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299916 0
Human Research Ethics Committee Townsville Hospital and Health Service
Ethics committee address [1] 299916 0
Ethics committee country [1] 299916 0
Australia
Date submitted for ethics approval [1] 299916 0
01/11/2017
Approval date [1] 299916 0
09/11/2017
Ethics approval number [1] 299916 0
HREC/17/QTHS/196

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2513 2513 0 0
/AnzctrAttachments/374730-FiGSS Trial Protocol V3 Registry.pdf (Protocol)
Attachments [2] 2514 2514 0 0
/AnzctrAttachments/374730-HREC17QTHS196_3 Approved.pdf (Ethics approval)
Attachments [3] 2515 2515 0 0
/AnzctrAttachments/374730-FiGSS PICF Master v2.pdf (Participant information/consent)

Contacts
Principal investigator
Name 81978 0
Dr Ekta Paw
Address 81978 0
Surgical Services Group
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country 81978 0
Australia
Phone 81978 0
+61408719233
Fax 81978 0
Email 81978 0
[email protected]
Contact person for public queries
Name 81979 0
Ekta Paw
Address 81979 0
Surgical Services Group
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country 81979 0
Australia
Phone 81979 0
+61408719233
Fax 81979 0
Email 81979 0
[email protected]
Contact person for scientific queries
Name 81980 0
Ekta Paw
Address 81980 0
Surgical Services Group
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country 81980 0
Australia
Phone 81980 0
+61408719233
Fax 81980 0
Email 81980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to small centres involved in recruitment for privacy reasons.


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
SourceTitleYear of PublicationDOI
EmbaseProtocol for an open randomised controlled trial investigating Fibrin Glue in Skin grafts for Skin cancer (FiGSS).2022https://dx.doi.org/10.1136/bmjopen-2022-064431
N.B. These documents automatically identified may not have been verified by the study sponsor.