Condition category
Cancer
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr DW England

ORCID ID

Contact details

GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265160831

Study information

Scientific title

Acronym

Study hypothesis

Does the use of Quixil surgical sealant reduce the post-operative blood and lymph loss, thereby reducing the time to drain removal, shortening the post-operative hospital stay?

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer: Breast

Intervention

Patients undergoing either mastectomy or Wide Local Excision with axillary clearance / level 1&2 sampling, will be randomised to either receive an application of Quixil surgical sealant at wound closure or standard wound closure. Quixil will he spray applied to all wound surfaces prior to closure and drain insertion, in the group randomised to receive this arm of treatment. Two low vacuum suction drains will be placed, one in the axilla and the other in the chest wound. Vacuum will be applied after wound closure or 5 minutes, which ever is longer.

Time to drain removal and discharge from hospital, and drain output volumes will be the primary end points. Patient's demographic data and operative data will be collected to ensure standardisation of the two randomised groups. Any operative and postoperative complications will be recorded including wound seroma formation. Patients will be followed up in the out patients department to examine the wound at fourteen days.

17/08/2012: Please note that this study was stopped in 2008 due to issues with participant recruitment

Intervention type

Drug

Phase

Not Specified

Drug names

Quixil

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/09/2003

Overall trial end date

19/09/2008

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

40 patient volunteers with proven breast cancer already booked to undergo surgery. Inclusion Criteria:
1. Patients with breast cancer undergoing either mastectomy or WLE and axillary clearance
2. Patients able and willing to sign the Patient Informed Consent Form and agree to the study requirements
3. Patients with a normal coagulation profile

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

40

Participant exclusion criteria

1. Patients with signs and/or symptoms of systemic and/or local infection
2. Patients having a re-operation
3. Patients with suspected inflammatory breast cancer
4. Patients requiring concomitant surgery
5. Patients taking any form of anticoagulants

Recruitment start date

19/09/2003

Recruitment end date

19/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

GI Surgery
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

University Hospital Birmingham NHS Trust (UK), 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