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ISRCTN
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ISRCTN56652573
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ClinicalTrials.gov identifier
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Public title
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Single centre randomised study to discover whether fibrin glue is more effective than surgery in the treatment of pilonidal sinus
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0077161769
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Study hypothesis
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To determine the effectiveness of fibrin glue in the treatment of pilonidal sinus, as compared to standard surgical techniques.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Added Deptember 2008: Nottingham One Ethics Research Committee (UK).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Skin and Connective Tissue Diseases: Pilonidal sinus
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Participants - inclusion criteria
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Patients with pilonidal sinus under the care of Consultant Surgeons within the Derby NHS Foundation Trust will be identified from GP referral letters to surgical outpatients. Patients will be approached on visiting outpatients. Patients will be given both verbal and written information to enable them to make an informed decision as to whether to proceed. Patients have the right to withdraw at any stage.
Inclusion criteria:
1. Male and Female subjects with pilonidal sinus
2. Patients > 18 years old
3. Only women taking adequate contraceptive precautions
4. Patients with no history of allergy to any of the product contents of Tisseel Kit sealant.
5. Ability to provide valid informed consent.
6. Patients who have no objections on moral/religious grounds to the product (Tisseel contains human fibrin and Aprotinin from cattle)
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Participants - exclusion criteria
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1. Women who are lactating
2. Women who are pregnant
3. Women of childbearing age who are unwilling to take adequate contraceptive precautions
4. Patients with allergic diathesis or patients who have had previous exposure to aprotinin
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Anticipated start date
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30/03/2005
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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40
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Interventions
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Randomised Controlled Trial. Patients that present with pilondial sinus at outpatient clinic will be invited to participate in the study. Forty patients will be recruited. Having given informed consent, patients will be randomised into two groups and the second group will be the control group. The treatment group will be prepared for surgery as routine. Under a general anaesthetic the openings of the sinus. The pits will then be injected with fibrin glue (Tisseel, Baxter Healthcare Ltd, Newbury, UK). One to be mls of glue will be injected. A simple non-woven dressing will be applied. No antibiotic prophylaxis will be given. Patients will be discharged from hospital after the procedure. Six months after the procedure patients will be contacted by telephone and complications or recurrences will be recorded. They will be given a linear analogue pain score to complete daily for the week following their procedure. This will record the patients pain and also the time taken to return back to normal activities. The patients in the control group will be managed as above, but instead of being treated with fibrin glue they will receive standard surgery.
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Primary outcome measure(s)
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1. Reduction in Pain
2. Healing rate.
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Secondary outcome measure(s)
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Added September 2008:
Recurrence, infection, return to work and cost.
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Sources of funding
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Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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1. 2005 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/15868239
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Contact name
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Mr
J
Lund
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Address
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Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
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City/town
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Derby
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Zip/Postcode
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DE22 3DT
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Country
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United Kingdom
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Tel
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+44 01332 340131 Ext. 5548
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Fax
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+44
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Email
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jon.lund@nottingham.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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28/03/2012
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Date ISRCTN assigned
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29/09/2006
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