BMJ open · 2022
Protocol for an open randomised controlled trial investigating Fibrin Glue in Skin grafts for Skin cancer (FiGSS).
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Paw Ekta, Vangaveti Venkat, Zonta Mark, Heal Clare
Аннотация
INTRODUCTION: Skin cancer is a common disease in the tropics, and oncological resection typically requires reconstruction with skin grafts. Fibrin glue, initially established as a haemostatic agent, has been studied extensively as an adhesive for skin grafts in burns. This study aims to investigate the use of fibrin as an adhesive for split skin grafts in skin cancers.
METHODS AND ANALYSIS: The study design is a prospective randomised controlled trial with the aim of investigating the impact of two different methods of split skin graft fixation. The intervention of fibrin glue will be compared with the control of staples or sutures. The trial will be conducted at two sites, a public hospital and a private hospital in Townsville, Australia, over a 24-month period with 334 participants to be recruited. Consecutive patients presenting for skin excisions and grafting will be eligible to participate in this study. Randomisation will be on the level of the patient. The primary outcome is graft take based on wound healing at 1 month. Secondary outcomes will be pain on dressing changes and operative time.
ETHICS AND DISSEMINATION: The study has been approved by The Townsville University Hospital Human Research Ethics Committee. Findings will be disseminated in conference presentations and journals and through online electronic media.
TRIAL REGISTRATION NUMBER: ACTRN12618000484246.
METHODS AND ANALYSIS: The study design is a prospective randomised controlled trial with the aim of investigating the impact of two different methods of split skin graft fixation. The intervention of fibrin glue will be compared with the control of staples or sutures. The trial will be conducted at two sites, a public hospital and a private hospital in Townsville, Australia, over a 24-month period with 334 participants to be recruited. Consecutive patients presenting for skin excisions and grafting will be eligible to participate in this study. Randomisation will be on the level of the patient. The primary outcome is graft take based on wound healing at 1 month. Secondary outcomes will be pain on dressing changes and operative time.
ETHICS AND DISSEMINATION: The study has been approved by The Townsville University Hospital Human Research Ethics Committee. Findings will be disseminated in conference presentations and journals and through online electronic media.
TRIAL REGISTRATION NUMBER: ACTRN12618000484246.