A prospective controlled trial comparing silicone and PVC closed system wound drains

ISRCTN ISRCTN80399819
DOI https://doi.org/10.1186/ISRCTN80399819
Protocol serial number N0123165848
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder University Hospitals of Leicester NHS Trust (UK), Departmental Research Fund
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
23/04/2015
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 Eoin O'Broin
Scientific

c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleA prospective controlled trial comparing silicone and PVC closed system wound drains
Study objectivesTo ascertain if there are differences in comfort levels for patients between two generic wound drain types. One type being the cheaper more conventional but stiffer plastic drain and the second a newer softer silicone drain.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery
InterventionConventional stiffer plastic drain vs newer softer silicone drain
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/04/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaAll patients having a breast reduction, breast reconstruction or an abdominoplasty procedure under the care of Mr O'Broin.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment10/01/2005
Date of final enrolment30/04/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan