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.

Objectives

To assess if FS improves wound related outcomes in patients undergoing soft-tissue surgery of the head and neck anatomical region that would commonly require a drain.

Type Of Review

Systematic review and meta-analysis of randomised controlled trials (RCTs).

Search Strategy

Medline (1946 – 2016), EMBASE (1974 – 2016), PubMed (2016), CENTRAL (2016), ClinicalTrials. gov (2016), WHO International Clinical Trials Registry and Platform (2016), Research Gate (2016).

Evaluation Method

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 2 RCTs on thyroidectomy, 3 on 'surgery involving neck dissection' (central or lateral), 5 on rhytidectomy and 1 on parotidectomy. There was a tendency for FS to reduce 'mean total drainage volume' (mean difference -26.86ml, 95%CI -43.41 to -10.31, I²=97%, p=0.001). Sub-group analysis of thyroidectomy (mean difference -36.36ml, 95%CI -72.82 to 0.10, I²=79%, p=0.05), 'surgery involving neck dissection' (mean difference -33.21ml, 95%CI -70.01 to 3.59, I²=94%, p=0.08) and rhytidectomy (mean difference -13.79ml, 95%CI -17.57 to -10.01, I²=0%, p<0.00001) 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=0.25) and 'hospital length of stay' by 2.09 days (95% CI -5.18 to 0.99, I²=97%, p=0.18) 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=0.29) 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.

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