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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
Trial acronym
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 4
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
Name [1] 298987 0
The Townsville Hospital
Address [1] 298987 0
The Townsville Hospital
100 Angus Smith Dr
Douglas Qld 4814
Country [1] 298987 0
Primary sponsor type
Ekta Paw
Surgical Services Department
The Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Secondary sponsor category [1] 298210 0
Name [1] 298210 0
James Cook University
Address [1] 298210 0
1 James Cook Dr
Douglas QLD 4811
Country [1] 298210 0
Secondary sponsor category [2] 298228 0
Name [2] 298228 0
The Townsville Hospital
Address [2] 298228 0
100 Angus Smith Dr
Douglas QLD 4814
Country [2] 298228 0

Ethics approval
Ethics application status
Ethics committee name [1] 299916 0
Human Research Ethics Committee Townsville Hospital and Health Service
Ethics committee address [1] 299916 0
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Ethics committee country [1] 299916 0
Date submitted for ethics approval [1] 299916 0
Approval date [1] 299916 0
Ethics approval number [1] 299916 0

Brief summary
The purpose of this study is to compare the use of fibrin glue with sutures or staples for affixing skin grafts in skin cancer patients.

Who is it for?

You may be eligible for the trial if you are over the age of 18 and have been diagnosed with any type of skin cancer.
If your skin cancer requires a skin graft to close the wound then you may be able to enrol in this trial. If you agree to enrol you would answer some basic questions and be randomised to have either glue or sutures/staples to affix your skin graft. Your surgery and appointments will be the same as if you weren’t enrolled in the trial. After the surgery you would have an appointment at one week and one month where your wound will be reviewed, your pain noted and photographs taken.

We hope this research will be able to decrease skin graft failure in patients who have skin grafts for skin cancer.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2513 2513 0 0
Attachments [2] 2514 2514 0 0
Attachments [3] 2515 2515 0 0
/AnzctrAttachments/374730-FiGSS PICF Master v2.pdf (Participant information/consent)

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
Phone 81978 0
Fax 81978 0
Email 81978 0
Contact person for public queries
Name 81979 0
Dr Ekta Paw
Address 81979 0
Surgical Services Group
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country 81979 0
Phone 81979 0
Fax 81979 0
Email 81979 0
Contact person for scientific queries
Name 81980 0
Dr Ekta Paw
Address 81980 0
Surgical Services Group
Townsville Hospital
100 Angus Smith Dr
Douglas QLD 4814
Country 81980 0
Phone 81980 0
Fax 81980 0
Email 81980 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Due to small centres involved in recruitment for privacy reasons.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Clinical study report
Ethical approval
Summary results
No Results