The role of Quixil Human Surgical Sealant in Mastectomy and Wide Local Excision with Axillary Clearance
| ISRCTN | ISRCTN48887945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48887945 |
| Secondary identifying numbers | N0265160831 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 17/08/2012
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr DW England
Scientific
Scientific
GI Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Quixil |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 19/09/2003 |
| Completion date | 19/09/2008 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/09/2003 |
| Date of final enrolment | 19/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
GI Surgery
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
