OBJECTIVE:Fibrin glue is used as a haemostatic agent or as a sealant. The aim of this study is to objectively evaluate the efficacy of the use of fibrin glue Quixil - a human surgical sealer - in tonsillectomy, for the reduction of post-operative inflammatory response. STUDY DESIGN: A prospective randomized single-blind study. METHODS: The study was performed on 40 consecutive patients undergoing adenotonsillectomy (T&A). Patients were randomly assigned to one of two sub-groups: a study group and a control group. The tonsillar beds of patients in the study group were coated with fibrin glue (Quixil, OMRIX biopharmaceuticals) at the end of the operation; the patients in the control group were treated for hemostasis without the use of fibrin glue. Complete blood counts and circulating pro-inflammatory cytokines (assayed by specific immunoassay - ELISA) were assessed in samples drawn pre- and 16 h post-tonsillectomy. RESULTS:Forty patients (aged 5.8 ± 2.4 years) were consecutively enrolled; 45% (18) of the patients were treated withfibrin glue, 55% (22) were not. Compared to controls, Quixil-treated patients demonstrated a reduction in post-tonsillectomy circulating leukocytes (29.2% vs. 45.4%, p<0.05), neutrophiles (28.3% vs. 42.1%, p<0.05), IL-6 (+1% vs. +42%, p<0.05), and TNF-alpha (+8% vs. +26%, p<0.05. CONCLUSIONS: Intra-operative fibrin glue therapy is associated with decreased immediate inflammatory response following T&A. Further studies are warranted to assess long-term outcome. LEVEL OF EVIDENCE: 1B.
RCT Entities:
OBJECTIVE: Fibrin glue is used as a haemostatic agent or as a sealant. The aim of this study is to objectively evaluate the efficacy of the use of fibrin glue Quixil - a human surgical sealer - in tonsillectomy, for the reduction of post-operative inflammatory response. STUDY DESIGN: A prospective randomized single-blind study. METHODS: The study was performed on 40 consecutive patients undergoing adenotonsillectomy (T&A). Patients were randomly assigned to one of two sub-groups: a study group and a control group. The tonsillar beds of patients in the study group were coated with fibrin glue (Quixil, OMRIX biopharmaceuticals) at the end of the operation; the patients in the control group were treated for hemostasis without the use of fibrin glue. Complete blood counts and circulating pro-inflammatory cytokines (assayed by specific immunoassay - ELISA) were assessed in samples drawn pre- and 16 h post-tonsillectomy. RESULTS: Forty patients (aged 5.8 ± 2.4 years) were consecutively enrolled; 45% (18) of the patients were treated with fibrin glue, 55% (22) were not. Compared to controls, Quixil-treated patients demonstrated a reduction in post-tonsillectomy circulating leukocytes (29.2% vs. 45.4%, p<0.05), neutrophiles (28.3% vs. 42.1%, p<0.05), IL-6 (+1% vs. +42%, p<0.05), and TNF-alpha (+8% vs. +26%, p<0.05. CONCLUSIONS: Intra-operative fibrin glue therapy is associated with decreased immediate inflammatory response following T&A. Further studies are warranted to assess long-term outcome. LEVEL OF EVIDENCE: 1B.