Protocol for an open randomised controlled trial investigating Fibrin Glue in Skin grafts for Skin cancer (FiGSS).
Dermatological tumours
SURGERY
Surgical dermatology
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
08 11 2022
08 11 2022
Historique:
entrez:
9
11
2022
pubmed:
10
11
2022
medline:
15
11
2022
Statut:
epublish
Résumé
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. 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. 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. ACTRN12618000484246.
Identifiants
pubmed: 36351733
pii: bmjopen-2022-064431
doi: 10.1136/bmjopen-2022-064431
pmc: PMC9644346
doi:
Substances chimiques
Fibrin Tissue Adhesive
0
Banques de données
ANZCTR
['ACTRN12618000484246']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e064431Informations de copyright
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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