Before the treatment with the Pressfit® anal fistula plug, a loose seton is placed in the fistula; it is kept in place for a minimum period of two months or in any case until complete reduction of the residual abscess cavities observed in the preoperative study with ERUS and/or RMI. The use of a loose seton promotes drainage of the fistula and makes the fistulous tract more regular and cylindrical.
All patients are surgically operated under spinal anesthesia in lithotomy position. The anal cavity having been explored with anal retractor.
After two months or more the seton is removed and an accurate curettage of the fistula is performed with the use of a brush, in order to have a complete evacuation of fibrous tissues and corpuscular waste contained in the fistula tract, promoting bleeding from the fistulous tissues.
-Pressfit® anal fistula plug must be hydrated in saline solution for 5-10 minutes, according the instruction for use.
- Fix a non-absorbable suture to the distal end of the plug.
- Use the suture like a probe and insert it in the fistulous tract from the internal opening to the external one.
- The plug will have the larger part positioned in the internal opening and the smallest one exceeding from the external opening.
- Suture the larger part of the plug in the internal opening with 2/0 absorbable suture.
- Close the internal orefice with a small mucosal flap.
- Cut the exceeding part of the plug from the external opening and fix it with another 2/0 absorbable anchor point. - Enlarge the external opening with a scalpel blade to promote drainage and a faster closure of the wound.
- A transanal gauze is put in place for 12 hours after surgery to prevent contamination of wounds and compression of the flap.
The Pressfit® anal fistula plug is made of deantigenated porcine dermis through a enzymatic treatment at low temperatures. This process preserves the integrity of the extracellular matrix that acts as a natural scaffold for the formation of new tissue.
The collagen fibers of types I and III have not been cross-linked in order to preserve the natural structure of the protein and promote cell invasion; the remodelling process will transform the plug in new healthy patient's tissue.
Pressfit® anal fistula plug has a wedge "solid" design. Its geometric shape prevents axial displacement and rotation thanks to the presence of sharp edges. Its solid shape allows intimate contact with the fistula.
Primary stability and intimate contact are biomechanical conditions necessary for the cell invasion in the collagen matrix and the tissue remodeling.
The preliminary study found out the higher healing rate in fistulas with the following characteristics:
- Medium-high transphincteric fistulas
- Fistulas not associated with fissures
- Simple fistulas, at the first surgical treatment
Anal Fistula Repair with Acellular Dermal Matrix Plug:
Description of a Novel Technique and Early Results
Sphincters-saving treatment of primary anal fistula with a new ADM plug:
a prospective study