Permacol for treating anal fistulae

Level of innovation

All specialist commentators agreed that Permacol is a variation on existing technologies such as fibrin glue and fibrin plugs. One specialist commentator noted that the evidence for these techniques suggests that they have a low efficacy. One specialist commentator noted that the injection of stem cells into fistula tracts to induce healing is a new technique that is currently being evaluated and which may eventually supersede Permacol. One specialist commentator felt that the fistula plug had probably superseded Permacol already.

Potential patient impact

The specialist commentators considered that Permacol had a number of potential patient benefits, including fewer hospital visits for post-operative wound care, reduced recurrence of fistulae and reduced post-operative incontinence. However, they noted that most of these benefits would only be realised if long-term healing rates were high. One specialist commentator noted that people having Permacol report high satisfaction and minimal pain.

One specialist commentator noted that the evidence did not indicate a particular patient group that would benefit from Permacol, because most of the evidence was from treating idiopathic fistulae and not fistulae in people with Crohn's disease. Two commentators noted that there was some evidence that Permacol may be more beneficial in shorter, lower fistula tracts, but another noted that most of these can be managed safely by fistulotomy.

Another specialist commentator noted that Permacol may be of particular benefit to women with occult sphincter injury after childbirth.

One specialist commentator stated that Permacol would have very similar benefits to collagen plugs, and that people with high transphincteric fistulae would benefit the most from this kind of treatment.

Potential system impact

All specialist commentators agreed that few changes would be needed to facilities and NHS services for Permacol to be implemented. They stated that training would be minimal, suggesting that a demonstration video or one-off instructional course would suffice.

One specialist commentator stated that Permacol could lead to cost savings for the NHS by reducing the number of procedures needed to heal an anal fistula and the need for long-term wound care. Two specialist commentators noted that these benefits might be realised but that further evidence should be gathered to test this. One specialist commentator stated that they were unsure of any benefits because of the uncertainty of the evidence. Another 2 stated that system benefits were unlikely unless higher healing rates were realised.

General comments

One specialist commentator noted that healing in the trials may have simply been because the internal opening was closed and not because of Permacol. They suggested that a direct comparison of Permacol with closure of the internal opening only would be needed to test this.

One specialist commentator noted that in the Maserati 100 trial, failure to heal seemed to be related to residual infection at the time of injection. They felt that Permacol should not currently be used outside of a clinical trial setting.