INTENDED USE:
The SURGISIS Anal Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anorectal fistulas. The device is supplied sterile and is intended for one time use.

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS:
   • This device is derived from a porcine source and should not
      be used for patients sensitive to porcine materials.
   • Not for vascular use

PRECAUTIONS:
   • Do not resterilize. Discard all open and unused portions.
   • Device is sterile if the package is dry, unopened and undamaged.
      Do not use if the package seal is broken.
   • Discard device if mishandling has caused possible damage
      or contamination, or if the device is past its expiration date.
   • Do not implant the device in a grossly infected or abscessed
      fistula tract.
   • Ensure that the device is rehydrated prior to placement,
      cutting, or suturing.

GENERAL:
   • Users should be familiar with surgical technique for anorectal
      fistula repair.
   • Users should exercise good surgical practice for the management
      of clean-contaminated, contaminated or infected fields.
   • The potential for infection of the graft material following implantation
      may be reduced by the use of prophylactic antibiotics, and cleaning
      of the fistula tract. (see Use of Antimicrobials)
   • SURGISIS Anal Fistula Plug should be handled aseptically, minimizing
      contact with latex gloves.
   • SURGISIS Anal Fistula Plug should be introduced through
      the internal (primary) fistula opening.
   • SURGISIS Anal Fistula Plug should be drawn into the fistula tract
      only until the internal (primary) opening is satisfactorily
      closed / occluded.
   • The external (secondary) opening of the fistula tract should
      remain open.
   • IMPORTANT: Users should counsel patients on abstaining
      from heavy lifting or strenuous activity for a period of two
      weeks after anal fistula plug placement.

POTENTIAL COMPLICATIONS:
Complications that can occur with the SURGISIS Anal Fistula Plug include, but are not limited to: inflammation, induration, migration, extrusion, seroma formation, infection, abscess, fistula recurrence, and delayed or failed incorporation of the device. If any of the following conditions occur and cannot be resolved, device removal should be considered:

STORAGE:
This device should be stored in a clean, dry location at room temperature.

STERILIZATION:
This device has been sterilized with ethylene oxide.

SUGGESTED INSTRUCTIONS FOR USE:
These recommendations are designed to serve only as a general guideline. They are not intended to supersede the institutional protocols or professional clinical judgment concerning patient care.

NOTE: Handle device using aseptic technique.

REQUIRED MATERIALS:
   • A sterile dish (kidney dish or other bowl)
   • Rehydration fluid: at least 200 ml of room temperature
      sterile saline or sterile lactated Ringer's solution
   • Suitable resorbable suture, such as: 0 chromic,
      2-0 vicryl, or 0 vicryl.

PREPARATORY:

1. From the box, remove the outer package containing SURGISIS Anal Fistula Plug.
2. Using aseptic technique, remove the inner pouch containing the SURGISIS Anal Fistula Plug from the outer package. Place the inner pouch in the sterile field.
3. Using sterile gloved hands, open the inner pouch carefully, and aseptically remove the SURGISIS Anal Fistula Plug with a sterile instrument. Place the SURGISIS Anal Fistula Plug into the sterile dish in the sterile field.
4. Tie a suitable resorbable suture (approximately 12 inches in length) around the tail (narrow end) of the plug for pulling it into the fistula tract. (This step is not necessary if a suture seton will be placed, which can be tied to the narrow end of the plug.)
5. Add to the dish enough rehydration fluid to fully submerge the SURGISIS Anal Fistula Plug. Allow the fistula plug to rehydrate, fully submerged, for at least 5 minutes.
6. Prepare the patient and surgical site using standard surgical techniques appropriate for anal fistula repair.

NOTE: The recommended practice for preoperative bowel preparation in elective colorectal surgery includes mechanical bowel cleansing through the use of enemas and cathartic agents, and administration of prophylactic antimicrobial agents, oral or intravenous. Insufficient cleansing or inadequate antibacterial prophylaxis can predispose the patient to infections. [1-3]. (See Use of Antimicrobials)

PROCEDURAL:

1. Perform under local, regional, or general anesthesia.
2. Identify the internal (primary) fistula opening by inserting a sterile probe into the external (secondary) opening and navigating it through the fistula tract. Alternatively, injection of appropriate sterile fluids (saline or hydrogen peroxide) into the external (secondary) opening of the fistula tract and identifying the site of emergence at the internal (primary) opening can also be used to assist in identifying the location of the internal opening.
   
   NOTE: Failure to locate the internal (primary) opening may lead to persistence of the fistula. If the internal (primary) opening cannot be reliably identified, an alternative method of treatment should be considered.
   
   
3. Gently clean the fistula tract as thoroughly as possible by flushing the tract with sterile saline, hydrogen peroxide, or comparable solution. Do not enlarge the tract.
4. Insert a sterile hemostat, a fistula probe, seton or suitable instrument through the fistula tract, entering through the external (secondary) opening and exiting via the internal (primary) opening. A suture seton may be placed and subsequently tied to the narrow end of the SURGISIS Anal Fistula Plug for pulling it into the tract.
5. Grasp the suture attached to the tail (narrow end) of the fistula plug. Confirm that the plug is pulled tail-first into the internal (primary) opening, so the thicker end of the plug can be pulled snugly into the internal (primary) opening.
6. Draw the tie attached to the SURGISIS Anal Fistula Plug into the internal (primary) opening and through the fistula tract until slight resistance is felt and the plug securely blocks the internal (primary) opening.
   
   IMPORTANT: The internal opening is the high-pressure zone of the fistula, as well as the site of ingress of fecal debris. The thicker end of the plug must therefore be securely snugged into the internal (primary) opening to prevent ingress of fecal debris. In addition, the higher pressures within the rectum and anal canal assist in maintaining the plug in the fistula tract by simple mechanical force.
   
   
7. When the SURGISIS Anal Fistula Plug is properly positioned, trim away and discard any remaining portion of the plug that is not implanted within the fistula tract.
   
   IMPORTANT: The anal fistula plug should be trimmed at the level of the bowel wall at the internal opening in order to minimize contact with bowel contents.
   
   
8. Suture both ends of the SURGISIS Anal Fistula Plug in place with suitable resorbable suture. Refer to the illustrations for suggested suture placement. Suture the internal end of the SURGISIS Anal Fistula Plug securely to the adjacent tissue, obtaining adequate bites of bowel wall and fistula plug to prevent leakage of bowel contents into the fistula tract and to anchor the fistula plug to prevent migration through the tract. At the external (secondary) opening, suture the anal fistula plug, if exposed, with a suitably sized resorbable suture. If the anal fistula plug is not exposed, secure the end of the fistula plug to the skin at the rim of the opening using the protruding suture tie.
   
   NOTE: Do not close the external (secondary) opening completely, so as to allow continued drainage of the fistula tract. Complete obstruction of the external (secondary) opening may result in accumulation of fluid, infection, or abscess.
   
   
9. Place a sterile dressing over the implant site.

Use of Antimicrobials with SURGISIS Anal Fistula Plug
Because the SURGISIS Anal Fistula Plug is used in surgical fields where sterility cannot be assured, the use of antimicrobials is common practice and may prevent infectious complications.[1-3] Both mechanical bowel cleansing and antibiotic prophylaxis of the patient have been used successfully, and the U.S. Centers for Disease Control recommends bowel cleansing and administration of prophylactic enteric and intravenous antimicrobial agents before elective colorectal operations.[3](See reference for specific dose, timing, and drug choices.)

Typical gastrointestinal flora can be expected to include a variety of aerobic and anaerobic organisms. Therefore the following points should be considered:

   • Antimicrobials, if used topically or systemically, should provide
      coverage against a wide spectrum of aerobic and
      anaerobic organisms[4].
   • Mechanically prepare the colon by appropriate use of enemas
      and cathartic agents.
   • A dose of prophylactic antimicrobial agent should be given
      intravenously and timed such that a bactericidal concentration
      of the drug is established in serum and tissues when the device
      is implanted.
   • Maintain therapeutic levels of the agent in serum and tissues
      throughout the operation. [3]

The presence of certain antimicrobials may inhibit revascularization and/or infiltration of cells into the SURGISIS Anal Fistula Plug.[5-7] For example, gentamicin is known to hinder neovascularization, epithelialization, and keratinocyte growth,[6] while povidone iodine,[8] bacitracin,[5,8] polymyxin B,[9] and vancomycin[10] have all been reported to slow or inhibit wound healing. Careful consideration is required before using any antimicrobial or antiseptic (topical or systemic) that has not been proven compatible with surgical implantation and wound healing. However, no studies have been conducted to evaluate the combination of antimicrobials with SURGISIS Anal Fistula Plug placement.

SUGGESTED SUTURE PLACEMENT FOR ANCHORING THE SURGISIS ANAL FISTULA PLUG (To be performed after trimming the plug to fit the tract):

1. Retract the trimmed plug slightly from the fistula tract to expose several millimeters of the large diameter plug end. Pass the resorbable suture 2–3 mm deep through the plug, at approximately 3-4 mm from the large diameter end.
   
   
   
2. Use an appropriate surgical knot to tie the suture down to the end of the plug, leaving the suture thread untrimmed.
   
   
   
3. Pull the SURGISIS Anal Fistula Plug back into the tract, to the final position. Pass the suture approximately 5 to 8 mm from the primary opening, through the mucosa, submucosal and underlying deep tissue layers. Ensure that adequate bite depths are taken to penetrate the deep tissue layers.
4. Pass the suture through the head of the SURGISIS Anal Fistula Plug.
5. Pass the suture into the underlying deep tissues and up through the submucosa and mucosal layers, as illustrated.
   
   
   
6. Repeat the suturing instructions indicated in steps 3 thru 5 on the opposite side of the primary opening.
   
   
   
7. Tension the two loose ends of suture to draw the primary opening inward over the anal fistula plug, and tie the suture ends together. The head of the plug is now covered with tissue. There should be no part of the plug visible at the primary opening.
8. If the narrow end of the anal fistula plug is exposed, it should be cut so that no material protrudes from the secondary opening. Secure the narrow end of the plug to skin at the rim of the opening, leaving the external opening of the tract unobstructed to allow continued drainage.
   
   NOTE: No part of the SURGISIS Anal Fistula Plug should protrude from the fistula tract when the procedure is completed.
   
   
   

REFERENCES:

1. Nichols RL, Smith JW, Garcia RY, et al. Current practices of preoperative bowel preparation among North American colorectal surgeons. Clin Infect Dis 1997;Apr24(4):609-19.
2. Yabata E, Okabe S, Endo M. A prospective, randomized clinical trial of preoperative bowel preparation for elective colorectal surgery-comparison among oral, systemic, and intraoperative luminal antibacterial preparations. J Med Dent Sci 1997;Dec44(4):75-80.
3. Mangram A, Horan TC, Pearson ML, et al. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC).
4. Aldridge KE, et al. Multicenter survey of the changing in vitro antimicrobial susceptibilities of clinical isolates of Bacteroides fragilis group, Prevotella, Fusobacterium, Porphyromonas, and Peptostreptococcus species. Antimicrob Agents Chemother 2001;45(4):1238-43.
5. Petroutsos G, et al. Antibiotics and corneal epithelial wound healing. Arch Ophthalmol 1983;101(11):1775-8.
6. Bang K, et al. Gentacoll hampers epithelialisation and neovascularisation in excisional wounds in hairless mice. Scand J Plast Reconstr Surg Hand Surg 1998;32(2):129-33.
7. Nelson JD, et al. Corneal epithelial wound healing: a tissue culture assay on the effect of antibiotics. Curr Eye Res 1990;9(3):277-85.
8. Kjolseth D, et al. Comparison of the effects of commonly used wound agents on epithelialization and neovascularization. J Am Coll Surg 1994;179(3):305-12.
9. Nakamura M, et al. Effects of antimicrobials on corneal epithelial migration. Curr Eye Res 1993;12(8):733-40.
10. Petroutsos G, Guimaraes R, and Pouliquen Y. The effect of concentrated antibiotics on the rabbit's corneal epithelium. Int Ophthalmol 1984;7(2):65-9.

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