TerminatedPhase 4ACTRN12618000484246

Glue in Skin Grafts for Skin Cancer

Determining the Efficacy of Fibrin Glue in Skin grafts for Skin cancer (FiGSS): Open randomised clinical trial


Sponsor

Ekta Paw

Enrollment

334 participants

Start Date

May 18, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • 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

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Interventions

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: Admini

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.


Locations(3)

The Townsville Hospital - Douglas

QLD, Australia

Townsville Day Surgery - Townsville

QLD, Australia

Mater Hospital Pimlico - Pimlico

QLD, Australia

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ACTRN12618000484246