title: Fibrin gel versus papain gel in the healing of chronic venous ulcers: A double-blind randomized controlled trial.
abstract: Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1-fibrin gel; Group 2-8% papain gel; Group 3-carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.
authors.affiliation: 1 General Basis of Surgery Post-graduating Course, Botucatu Medical School, UNESP - Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Illymack Cf
authors.initials: IC
authors.lastname: de Araújo
authors.affiliation: 2 Department of Urology, Botucatu Medical School, UNESP - Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Elenice
authors.initials: E
authors.lastname: Defune
authors.affiliation: 3 Department of Dermatology, Botucatu Medical School, UNESP - Paulista State University, Botucatu, Brazil.
authors.forename: Luciana Pf
authors.initials: LP
authors.lastname: Abbade
authors.affiliation: 3 Department of Dermatology, Botucatu Medical School, UNESP - Paulista State University, Botucatu, Brazil.
authors.forename: Hélio A
authors.initials: HA
authors.lastname: Miot
authors.affiliation: 4 Department of Surgery and Orthopedics, Botucatu Medical School, UNESP - Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Matheus
authors.initials: M
authors.lastname: Bertanha
authors.affiliation: 5 Department of Biostatistics, Institute of Biosciences, UNESP - Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Lídia R
authors.initials: LR
authors.lastname: de Carvalho
authors.affiliation: 6 Department of Biological Sciences, Bauru Sciences School, UNESP - Universidade Estadual Paulista, Bauru, Brazil.
authors.forename: Rosana R
authors.initials: RR
authors.lastname: Ferreira
authors.affiliation: 4 Department of Surgery and Orthopedics, Botucatu Medical School, UNESP - Universidade Estadual Paulista, Botucatu, Brazil.
authors.forename: Winston B
authors.initials: WB
authors.lastname: Yoshida
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001458:Bandages; D002908:Chronic Disease; D004311:Double-Blind Method; D004548:Elasticity; D005260:Female; D005337:Fibrin / Q000627:therapeutic use*; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D010206:Papain / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing
chemical_list: D005782:Gels; D005337:Fibrin; D010206:Papain
keywords: Varicose ulcer; fibrin modulating agents; papain; venous insufficiency; wound healing