The role of Quixil Human Surgical Sealant in Mastectomy and Wide Local Excision with Axillary Clearance

ISRCTN	ISRCTN48887945
DOI	https://doi.org/10.1186/ISRCTN48887945
Protocol serial number	N0265160831
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 17/08/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Cancer

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 DW England
Scientific

GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Quixil
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	19/09/2008
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	19/09/2003
Date of final enrolment	19/09/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

GI Surgery

Birmingham
B15 2TH
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