A pilot study to assess the efficacy of an anorectal fistula plug 1.2
Research type
Research Study
Full title
A pilot study to assess the efficacy of an anorectal fistula plug with sealing of the internal opening (Curaseal AF™) as a treatment for perianal fistula.
IRAS ID
195923
Contact name
Carolynne Vaizey
Contact email
Sponsor organisation
St Mark's Hospital, NWLH NHS Trust
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Perianal fistula is a condition where one develops an abnormal tract connecting the anal canal to the skin (such as an ear piercing). As stools pass through this tract it gets infected and may cause discharge or an abscess. Surgeons have adopted many methods to close off this abnormal tract, which includes laying it opening, use of setons (a thread running through it to prevent blockage), advancement flaps (close the internal opening with rectal mucosa) and permenant stoma. A novel idea has been the use of devices or substances to block the tract hoping it will seal off. Most of the devices that have been used to close the tract have not proven to be effective over laying open or the use of a seton. A major failure of the devices has been their early expulsion and their inability seal off the internal opening. The Curaseal plug may be able to overcome these shortcomings. It is a device made out of bovine (beef) collagen (a protein fibre) which is specially treated to remove all cells. The plug has a disc to seal the internal opening, with a suture to be placed at the external opening, which may prevent it falling out and ensure internal opening closure. We aim to assess the efficacy of Curaseal anal plug in patients with idiopathic uncomplicated fistulous tracts around the anus. Healing of fistula tract will be assessed both both clinically and radiologically with MR imaging.
REC name
Wales REC 7
REC reference
16/WA/0144
Date of REC Opinion
11 May 2016
REC opinion
Favourable Opinion