A prospective controlled trial comparing silicone and polyvinyl chloride (PVC) closed system wound drains
| ISRCTN | ISRCTN55951882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55951882 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/05/2005
- Registration date
- 24/08/2005
- Last edited
- 23/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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 E O'Broin
Scientific
Scientific
Department of Plastic Surgery
Infirmary Square
Leicester
LE1 5WW
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 to request a patient information sheet |
| Scientific title | A prospective controlled trial comparing silicone and polyvinyl chloride (PVC) closed system wound drains |
| Study objectives | We hypothesise that wound drains made of silicone may be better tolerated by patients (because it is softer than PVC) |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Comfort associated with wound drains |
| Intervention | We will be comparing comfort levels between 2 different drains - silicone and polyvinyl chloride (PVC) closed system wound drains |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Discomfort assessed using an analogue pain scoring system |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2005 |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25-30 |
| Key inclusion criteria | Patients undergoing plastic surgical procedures that require them to have at least 2 wound drains |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 01/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Leicester Royal Infirmary
Department of Plastic Surgery
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Government
University Hospitals Leicester 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 |
Editorial Notes
23/03/2018: No publications found, verifying study status with principal investigator.
26/02/2016: No publications found, verifying study status with principal investigator.
