The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients
| ISRCTN | ISRCTN35333172 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35333172 |
| Secondary identifying numbers | N0523136364 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 05/12/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 T Vijayganesh
Scientific
Scientific
Good Hope Hospital
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients |
| Study objectives | The trial proposes to establish the usefulness of 'Quixil' in reducing the incidence of post-operative seroma in breast cancer operations |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Breast |
| Intervention | 1. Quixil 2. No Quixil |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Reduction in seroma formation of more than 30% |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 100 |
| Key inclusion criteria | 100 patients undergoing mastectomy or wide local excision with axillary clearance for biopsy proven breast cancer. 50 to each arm. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Good Hope Hospital
Birmingham
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Good Hope Hospital NHS Trust (UK)
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 |
