Phase II randomised non-blinded trial of removal of vacuum on wound drainage bottles versus leaving vacuum intact
| ISRCTN | ISRCTN59740680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59740680 |
| Secondary identifying numbers | N0258184667 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 20/02/2020
- 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 Uccio Querci della Rovere
Scientific
Scientific
Breast/Surgical
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom
Study information
| Study design | Randomised, non-blinded (Phase II) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | - |
| Study objectives | To estimate the incidence in patients receiving standard care and also in patients having the vacuum removed early. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer: Breast |
| Intervention | Standard care vs vacuum removed early. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 11/01/2006 |
| Completion date | 08/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 |
| Key inclusion criteria | 50 RMH patients who are adult women aged over 18 years old and who are undergoing axillary dissection for breast cancer. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 11/01/2006 |
| Date of final enrolment | 08/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Breast/Surgical
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 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
The Royal Marsden NHS Foundation Trust (UK)
No information available
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 |
Editorial Notes
20/02/2020: No publications found, all search options exhausted, study status unverified.
