Utility of BioGlue® surgical adhesive in preventing air leaks in lung volume reduction surgery (LVRS)

ISRCTN	ISRCTN07886743
DOI	https://doi.org/10.1186/ISRCTN07886743
Protocol serial number	Version 2
Sponsor	Heart of England NHS Foundation Trust (UK)
Funder	CryoLife Europa Ltd (UK) - educational grant

Submission date: 26/02/2009
Registration date: 24/07/2009
Last edited: 12/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Pala Rajesh
Scientific

Consultant Thoracic Surgeon
Regional Department of Thoracic Surgery
Birmingham Heartlands Hospital
Heart of England NHS Foundation Trust
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Phone	+44 121 424 3561
Email	pala.rajesh@heartofengland.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised self-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A controlled trial comparing stapling with BioGlue® surgical adhesive versus stapling with buttressed bovine pericardium in lung volume reduction surgery (LVRS)
Study objectives	BioGlue® on staple line is as effective as stapling with pericardial buttressing in reducing air leaks in lung volume reduction surgery (LVRS). Phase 1 will establish the role and efficacy of BioGlue® in LVRS and phase 2 will compare its benefits over buttressed pericardial stapling.
Ethics approval(s)	Birmingham East North and Solihull Research Ethics Committee approved in July 2005 (ref: 05/Q2703/77). Amendment in January 2009.
Health condition(s) or problem(s) studied	Surgery for emphysema
Intervention	Patients are randomised via sealed randomised envolopes opened on the day of surgery. Patients are then randomised to LVRS with two different adjuncts to staple line: 1. BioGlue® 2. Pericardial buttress
Intervention type	Other
Primary outcome measure(s)	To demonstrate an increase in the frequency of an air leak free post-operative hospital course for patients receiving BioGlue® as a pneumostatic sealant as compared to patients receiving the pericardial buttressed stapling. Post-operatively, occurrence of air leaks will be assessed on a per patient basis, twice daily.
Key secondary outcome measure(s)	1. Incidence of re-operation due to air leaks 2. Volume of fluid loss in chest tube drain 3. Time to air leak cessation 4. Incidence of complications/adverse events 5. Early (hospital discharge) mortality and late mortality (through final follow-up) Measured twice daily.
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	25
Key inclusion criteria	1. Patients undergoing LVRS 2. Forced expiratory volume in one second (FEV1) less than 40% 3. FEV1/forced vital capacity (FVC) ratio less than 50% following challenges with beta 2 agonists/ipratropium bromide and a trial of oral corticosteroids 4. Residual volume of greater than 140% 5. Severe emphysema with heterogeneity ("target areas") documented on high resolution computed tomography (CT) scans 6. Less than 75 years of age, but greater than 18 years of age, either sex 7. Clinically stable for 1 month before entry to the study
Key exclusion criteria	1. Patients who do not consent to the trial 2. Patients with known hypersensitivity to albumin, bovine products, or glutaraldehyde 3. Patients who have been treated with an investigational product and have not completed the entire follow-up period for that investigational product 4. Patients who are unwilling or unable to complete all study evaluations
Date of first enrolment	01/09/2005
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Consultant Thoracic Surgeon

Birmingham
B9 5SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/07/2016: No publications found, verifying study status with principal investigator.