Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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 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

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

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

Publication citations

Additional files

Editorial Notes