title: Fibrin sealants in soft tissue surgery of the head and neck: A systematic review and meta-analysis of randomised controlled trials.
abstract: BACKGROUND
  Fibrin sealants (FS) are commercially available products used in surgical wounds as adjuncts to haemostasis and closure of dead space. The role of FS in soft tissue head and neck surgery has not been established.
  
  
  OBJECTIVE
  To assess whether FS improves wound-related outcomes in patients undergoing soft tissue surgery of the head and neck anatomical region that would commonly require a drain.
  
  
  METHODS
  Systematic review and meta-analysis of randomised controlled trials (RCTs).
  
  
  METHODS
  MEDLINE (1946-2016), EMBASE (1974-2016), PubMed (2016), CENTRAL (2016), ClinicalTrials.gov (2016), WHO International Clinical Trials Registry and Platform (2016), Research Gate (2016).
  
  
  METHODS
  Two independent reviewers screened and selected studies. Included studies were assessed for risk of bias and data extracted using a predetermined data collection form.
  
  
  RESULTS
  Of the 421 studies that were screened, 11 RCTs met the inclusion criteria. There were two RCTs on thyroidectomy, three on "surgery involving neck dissection" (central or lateral), five on rhytidectomy and one on parotidectomy. There was a tendency for FS to reduce "mean total drainage volume" (mean difference -26.86 mL, 95% CI -43.41 to -10.31, I2=97%, P=.001). Subgroup analysis of thyroidectomy (mean difference -36.36 mL, 95% CI -72.82 to 0.10, I2=79%, P=.05), "surgery involving neck dissection" (mean difference -33.21 mL, 95% CI -70.01 to 3.59, I2=94%, P=.08) and rhytidectomy (mean difference -13.79 mL, 95% CI -17.57 to -10.01, I2=0%, P < .00001) concurred with the overall analysis. There was a suggestion that FS may reduce "mean retention time of drains" by 1.24 days (95% CI -3.32 to 0.85, I2=99%, P=.25) and "hospital length of stay" by 2.09 days (95% CI -5.18 to 0.99, I2=97%, P=.18), but this was not statistically significant. There was also a suggestion that FS may protect against adverse events (RR 0.69, 95% CI 0.35 to 1.38, I2=0%, P=.29) and haematoma/seroma formation (RR 0.49, 95% CI 0.22 to 1.07, I2=0%, P=0.07).
  
  
  CONCLUSIONS
  There was considerable heterogeneity within the RCTs included in this study, thus restricting definitive conclusions. FS has however shown a definite benefit in rhytidectomy and potential benefit in other soft tissue head and neck surgical procedures. Further pragmatic trials are required particularly in the field of lateral neck dissection.
authors.affiliation: Department of Molecular and Clinical Cancer Medicine, Northwest Cancer Research Centre, University of Liverpool, Liverpool, UK.|Regional Maxillofacial Unit, Aintree University Hospital, Liverpool, UK.
authors.forename: M S
authors.identifier: http://orcid.org/0000-0003-3135-754X
authors.initials: MS
authors.lastname: Bajwa
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: C
authors.initials: C
authors.lastname: Tudur-Smith
authors.affiliation: Department of Molecular and Clinical Cancer Medicine, Northwest Cancer Research Centre, University of Liverpool, Liverpool, UK.|Regional Maxillofacial Unit, Aintree University Hospital, Liverpool, UK.
authors.forename: R J
authors.identifier: http://orcid.org/0000-0002-5157-4042
authors.initials: RJ
authors.lastname: Shaw
authors.affiliation: Department of Molecular and Clinical Cancer Medicine, Northwest Cancer Research Centre, University of Liverpool, Liverpool, UK.|Regional Maxillofacial Unit, Aintree University Hospital, Liverpool, UK.
authors.forename: A G
authors.identifier: http://orcid.org/0000-0001-9466-6038
authors.initials: AG
authors.lastname: Schache
mesh_terms: D004322:Drainage; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D006801:Humans; D037981:Neck Dissection / Q000009:adverse effects*; D010306:Parotid Gland / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D015361:Rhytidoplasty / Q000009:adverse effects*; D013965:Thyroidectomy / Q000009:adverse effects*
chemical_list: D015718:Fibrin Tissue Adhesive