A prospective controlled trial comparing silicone and polyvinyl chloride (PVC) closed system wound drains
| ISRCTN | ISRCTN55951882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55951882 |
| Protocol serial number | N/A |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | University Hospitals Leicester NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Discomfort assessed using an analogue pain scoring system |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Leicester Royal Infirmary
Department of Plastic Surgery
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
