Single centre randomised study to discover whether fibrin glue is more effective than surgery in the treatment of pilonidal sinus
| ISRCTN | ISRCTN56652573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56652573 |
| Secondary identifying numbers | N0077161769 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 28/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr J Lund
Scientific
Scientific
Derby Hospitals NHS Foundation Trust
Department of Surgery
University of Nottingham Medical school at Derby
Derby City General Hospital
Derby
DE22 3DT
United Kingdom
| Phone | +44 01332 340131 Ext. 5548 |
|---|---|
| jon.lund@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | To determine the effectiveness of fibrin glue in the treatment of pilonidal sinus, as compared to standard surgical techniques. |
| Ethics approval(s) | Added Deptember 2008: Nottingham One Ethics Research Committee (UK). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 1. Reduction in Pain 2. Healing rate. |
| Secondary outcome measures | Added September 2008: Recurrence, infection, return to work and cost. |
| Overall study start date | 30/03/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 30/03/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby Hospitals NHS Foundation Trust
Derby
DE22 3DT
United Kingdom
DE22 3DT
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Derby Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | pilot study results | 01/05/2005 | Yes | No |
