Condition category
Surgery
Date applied
17/05/2005
Date assigned
24/08/2005
Last edited
26/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr E O'Broin

ORCID ID

Contact details

Department of Plastic Surgery
Infirmary Square
Leicester
LE1 5WW
United Kingdom

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

Not specified

Trial type

Treatment

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

We will be using an analogue pain scoring system to assess the patient’s discomfort with each drain they have

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

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes

26/02/2016: No publications found, verifying study status with principal investigator