Contact information
Type
Scientific
Primary contact
Mr T Vijayganesh
ORCID ID
Contact details
Good Hope Hospital
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0523136364
Study information
Scientific title
The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients
Acronym
Study hypothesis
The trial proposes to establish the usefulness of 'Quixil' in reducing the incidence of post-operative seroma in breast cancer operations
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
Condition
Cancer: Breast
Intervention
1. Quixil
2. No Quixil
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Reduction in seroma formation of more than 30%
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2003
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
100 patients undergoing mastectomy or wide local excision with axillary clearance for biopsy proven breast cancer. 50 to each arm.
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2003
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Good Hope Hospital
Birmingham
B75 7RR
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Good Hope Hospital NHS Trust (UK)
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
Results - basic reporting
Publication summary