Condition category
Cancer
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Uccio Querci della Rovere

ORCID ID

Contact details

Breast/Surgical
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes