Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial.

Bajwa, Mandeep S ORCID: 0000-0003-3135-754X, Jackson, Richard, Dhanda, Jagtar, Tudur Smith, Catrin ORCID: 0000-0003-3051-1445, Shaw, Richard J ORCID: 0000-0001-7027-8997 and Schache, Andrew G ORCID: 0000-0001-9466-6038 (2023) Determining the Effectiveness of Fibrin Sealants in Reducing Complications in Patients Undergoing Lateral Neck Dissection (DEFeND): A Randomised External Pilot Trial. Cancers, 15 (20). 5073-.

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Official URL: http://dx.doi.org/10.3390/cancers15205073

Abstract

<h4>Objectives</h4>High-quality randomised controlled trials (RCT) to support the use of Fibrin Sealants (FS) in neck dissection (ND) are lacking. The DEFeND trial assessed critical pilot/feasibility questions and signals from clinical outcomes to inform a future definitive trial.<h4>Patients and methods</h4>The study design piloted was a blinded surgical RCT. All participants underwent unilateral ND for head and neck cancer. Interventional arm: ND with application of FS.<h4>Control arm</h4>ND alone. Feasibility outcomes included recruitment, effectiveness of blinding, protocol adherence and evaluating administrative processes. Clinical outcomes included surgical complications (primary outcome), drainage volume, time to drain removal, length of hospital stay, pain and the Neck Dissection Impairment Index.<h4>Results</h4>Recruitment completed ahead of time. Fifty-three patients were recruited, and 48 were randomised at a rate of 5.3 patients/month. Blinding of patients, research nurses and outcome assessors was effective. Two protocol deviations occurred. Two patients were lost to follow-up. The mean (SD) Comprehensive Complication Index in the interventional arm was 6.5 (12.8), and it was 9.9 (14.2) in the control arm. The median (IQR) time to drain removal (days) was shorter in the interventional arm (2.67 (2.42, 3.58) vs. 3.40 (2.50, 4.27)). However, this did not translate to a clinically significant reduction in median (IQR) length of hospital stay in days (intervention: 3.48 (2.64, 4.54), control: 3.74 (3.11, 4.62)).<h4>Conclusion</h4>The proposed trial design was effective, and a definitive surgical trial is feasible. Whilst there was a tendency for FS to improve clinical outcomes, the effect size did not reach clinical or statistical significance. (ISRCTN99181100).

Item Type:	Article
Uncontrolled Keywords:	clinical trials as topic, feasibility studies, fibrin tissue adhesive, head and neck neoplasms, neck dissection
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences > School of Medicine Faculty of Health and Life Sciences > Institute of Population Health Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	13 Dec 2023 11:38
Last Modified:	13 Dec 2023 11:38
DOI:	10.3390/cancers15205073
Open Access URL:	https://doi.org/10.3390/cancers15205073
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3177327