Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0258184667
Study information
Scientific title
Acronym
Study hypothesis
To estimate the incidence in patients receiving standard care and also in patients having the vacuum removed early.
Ethics approval
Not provided at time of registration
Study design
Randomised, non-blinded (Phase II)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer: Breast
Intervention
Standard care vs vacuum removed early.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To estimate the incidence of seroma in women having standard axillary care (vacuum left intact) and women having vacuum removed on 3rd day.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
11/01/2006
Overall trial end date
08/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
50 RMH patients who are adult women aged over 18 years old and who are undergoing axillary dissection for breast cancer.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
50
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
11/01/2006
Recruitment end date
08/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Breast/Surgical
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 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
The Royal Marsden NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
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