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

ISRCTN	ISRCTN07886743
DOI	https://doi.org/10.1186/ISRCTN07886743
Secondary identifying numbers	Version 2

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

Study design	Randomised self-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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.
Secondary outcome measures	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.
Overall study start date	01/09/2005
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Consultant Thoracic Surgeon

Birmingham
B9 5SS
United Kingdom

Sponsor information

Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom

Website	http://www.heartofengland.nhs.uk/

Funders

Funder type

Industry

CryoLife Europa Ltd (UK) - educational grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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