|
ISRCTN
|
ISRCTN35333172
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients.
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0523136364
|
|
Study hypothesis
|
The trial proposes to establish the usefulness of 'Quixil' in reducing the incidence of post-operative seroma in breast cancer operations
|
|
Lay summary
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer: Breast
|
|
Participants - inclusion criteria
|
100 patients undergoing mastectomy or wide local excision with axillary clearance for biopsy proven breast cancer. 50 to each arm.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/08/2003
|
|
Anticipated end date
|
01/12/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
1. Quixil
2. No Quixil
|
|
Primary outcome measure(s)
|
Reduction in Seroma formation of more than 30%
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Good Hope Hospital NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Mr
T
Vijayganesh
|
|
Address
|
Staff Grade Breast Surgeon
Good Hope Hospital
Sutton Coldfield
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B75 7RR
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
|
|
Address
|
The Department of Health,
Richmond House,
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
30/09/2004
|
|
Last edited
|
02/11/2011
|
|
Date ISRCTN assigned
|
30/09/2004
|
