Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265160831
Study information
Scientific title
Acronym
Study hypothesis
Does the use of Quixil surgical sealant reduce the post-operative blood and lymph loss, thereby reducing the time to drain removal, shortening the post-operative hospital stay?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Breast
Intervention
Patients undergoing either mastectomy or Wide Local Excision with axillary clearance / level 1&2 sampling, will be randomised to either receive an application of Quixil surgical sealant at wound closure or standard wound closure. Quixil will he spray applied to all wound surfaces prior to closure and drain insertion, in the group randomised to receive this arm of treatment. Two low vacuum suction drains will be placed, one in the axilla and the other in the chest wound. Vacuum will be applied after wound closure or 5 minutes, which ever is longer.
Time to drain removal and discharge from hospital, and drain output volumes will be the primary end points. Patient's demographic data and operative data will be collected to ensure standardisation of the two randomised groups. Any operative and postoperative complications will be recorded including wound seroma formation. Patients will be followed up in the out patients department to examine the wound at fourteen days.
17/08/2012: Please note that this study was stopped in 2008 due to issues with participant recruitment
Intervention type
Drug
Phase
Not Specified
Drug names
Quixil
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
19/09/2003
Overall trial end date
19/09/2008
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
40 patient volunteers with proven breast cancer already booked to undergo surgery. Inclusion Criteria:
1. Patients with breast cancer undergoing either mastectomy or WLE and axillary clearance
2. Patients able and willing to sign the Patient Informed Consent Form and agree to the study requirements
3. Patients with a normal coagulation profile
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40
Participant exclusion criteria
1. Patients with signs and/or symptoms of systemic and/or local infection
2. Patients having a re-operation
3. Patients with suspected inflammatory breast cancer
4. Patients requiring concomitant surgery
5. Patients taking any form of anticoagulants
Recruitment start date
19/09/2003
Recruitment end date
19/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list