Table 1

WHO trial registration data set

Primary registry and trial identifying numberAustralian New Zealand Clinical Trials Registry ACTRN12618000484246
Date of registration in primary registry04 April 2018
Secondary identifying numbersNil
Source(s) of monetary or material supportTownsville University Hospital grant
Primary sponsorTownsville University Hospital grant
Secondary sponsor(s)Nil
Contact for public queriesEP, MBBS, MPH (ekta.paw@my.jcu.edu.au)
Contact for scientific queriesEP, MBBS, MPH (ekta.paw@my.jcu.edu.au)
Public titleDetermining the efficacy of Fibrin Glue in Skin grafts for Skin cancer (FiGSS): open randomised clinical trial
Scientific titleDetermining the efficacy of Fibrin Glue in Skin grafts for Skin cancer (FiGSS: open randomised clinical trial
Countries of recruitmentAustralia
Health condition(s) or problem(s) studiedSkin cancer, skin graft failure.
Intervention(s)Active comparator: topical fibrin glue.
Placebo comparator: suture or staple fixation.
Key inclusion and exclusion criteriaAges eligible for study: ≥18 years.
Sexes eligible for study: both.
Accepts healthy volunteers: no.
Inclusion criteria:

  1. Will be undergoing surgery at one of the trial centres.

  2. Have any histological type of skin cancer.

Exclusion criteria:

  1. Adverse reaction to the product (fibrin glue).

  2. Hypersensitivity to bovine protein.

  3. Skin grafts on digits or genitalia.

  4. Pregnancy.

  5. Not cognitively intact to consent to participation.

  6. Known immunodeficiency (HIV, leukaemia, etc), or haemolytic anaemia.

  7. Skin conditions or medications affecting skin thickness and quality (eg, prolonged corticosteroid use, autoimmune conditions of skin).

  8. Chronic malnourishment.

Study typeInterventional
Allocation: randomised intervention model.
Masking: open with blinded outcome assessors.
Primary purpose: treatment.
Phase IV
Date of first enrolmentApril 2018
Target sample size334
Recruitment statusRecruiting
Primary outcome(s)Graft take based on wound healing at 1 month.
Key secondary outcomesPain on dressing changes and operative time.