Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective controlled trial comparing silicone and polyvinyl chloride (PVC) closed system wound drains
Acronym
Study hypothesis
We hypothesise that wound drains made of silicone may be better tolerated by patients (because it is softer than PVC)
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Discomfort assessed using an analogue pain scoring system
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2005
Overall trial end date
01/09/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing plastic surgical procedures that require them to have at least 2 wound drains
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25-30
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2005
Recruitment end date
01/09/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Department of Plastic Surgery
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Funders
Funder type
Government
Funder name
University Hospitals Leicester NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary