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Mr Peter Lunniss


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Be Part of Research - Trial Details - Management of idiopathic anal fistula using collagen
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Management of idiopathic anal fistula using collagen

Not Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Idiopathic anal fistulas deemed unsuitable for fistulotomy

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Not provided at time of registration

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Sep 2004 01 May 2008

Publications

2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19863602 results

Interventional

Intervention Type : Drug
Intervention Description : This is a randomised single-blind controlled study performed at two london (UK) hospitals, the Royal London Hospital and the Homerton University Hospital.

Intervention 1: Solid Permacol® implant Intevention 2: Milled Permacol® fibres suspended in fibrin glue

Permacol® (Tissue Science Laboratories plc) is a porcine derived acellular dermal sheet, predominately composed of Type I collagen (93 - 95%), with type III collagen and a small amount of elastin comprising the remainder. Sterile sheets 1.0 mm in thickness were used in this study. The alternative format is a 2.5 ml Permacol injection® (Tissue Science Laboratories plc), a 60% (wet weight/volume) suspension in saline of the cryogenically milled implant, with a defined particle size of 150 µm in diameter.

Fibrin glue: The 1.0 ml Tisseel Kit® - Two Component Fibrin Sealant (Baxter Healthcare Ltd, UK) was employed.

The implant was fashioned to the approximate dimensions of the fistula tract, and drawn into position using a suture, passed along a grooved fistula probe within the fistula tract.

The fibre suspension was prepared as follows: 1 ml Permacol injection® was injected into a 1.5 ml sterile Eppendorf Biopur® pipette tip (Eppendorf UK Limited, UK), and centrifuged at 1,100 rpm for 5 minutes. The saline supernatant was discarded, and the residual collagen fibres re-suspended in 1.0 ml calcium chloride solution supplied with the Tisseel Kit®. The individual components of the Tisseel Kit® were mixed, warmed in a Fibrinotherm™ (Baxter AG, Austria) and were then drawn up into two syringes (syringe 1: fibrinogen and aprotinin; syringe 2: thrombin and collagen fibres suspended in calcium chloride solution), which were subsequently placed in a Duploject™ (Baxter AG) two-syringe clip, where they shared a common plunger. A plastic double-lumen Y-connector joined these two syringes. This apparatus was then attached to a 21-gauge cannula, passed along a grooved fistula probe in the fistula tract.




You can take part if:



You may not be able to take part if:


Patients with either clinical or radiological (magnetic resonance imaging) evidence of secondary tracts or acute sepsis were excluded from the trial until these had been eradicated, leaving a single primary tract.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Homerton University Hospital NHS Foundation Trust
    London
    E9 6SR

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Mr Peter Lunniss



The study is sponsored by Queen Mary, University of London (UK) and funded by Local NHS Trusts (UK) - the trial was performed on NHS patients requring a surgical intervention at their local trusts; Tissue Science Laboratories plc (UK) - donated Permacol® unconditionally.



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Read full details for Trial ID: ISRCTN67277406
Last updated 27 March 2012

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