Condition category
Skin and Connective Tissue Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
28/03/2012
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 J Lund

ORCID ID

Contact details

Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
Derby
DE22 3DT
United Kingdom
+44 01332 340131 Ext. 5548
jon.lund@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077161769

Study information

Scientific title

Acronym

Study hypothesis

To determine the effectiveness of fibrin glue in the treatment of pilonidal sinus, as compared to standard surgical techniques.

Ethics approval

Added Deptember 2008: Nottingham One Ethics Research Committee (UK).

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

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Skin and Connective Tissue Diseases: Pilonidal sinus

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Reduction in Pain
2. Healing rate.

Secondary outcome measures

Added September 2008:
Recurrence, infection, return to work and cost.

Overall trial start date

30/03/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

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

Recruitment start date

30/03/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derby Hospitals NHS Foundation Trust
Derby
DE22 3DT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding

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

1. 2005 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/15868239

Publication citations

  1. Pilot study results

    Lund JN, Leveson SH, Fibrin glue in the treatment of pilonidal sinus: results of a pilot study., Dis. Colon Rectum, 2005, 48, 5, 1094-1096, doi: 10.1007/s10350-004-0905-4.

Additional files

Editorial Notes