Required Materials; Preparation - COOK Medical Biodesign Mode D'emploi

• Fistula persistence or recurrence
• Induration
STORAGE
Store the plug in a clean, dry location at room temperature.
STERILIZATION
The plug has been sterilized with ethylene oxide. Do not resterilize.
INSTRUCTIONS FOR USE

Required Materials

• Sterile basin
• Hydration fluid: room temperature sterile saline or sterile lactated Ringer's
solution
• Resorbable suture, such as 2-0 or 0 polydioxanone (PDO or PDS) or coated
polyglycolic acid suture (coated PGA)
• Silk suture
• 5 Fr catheter
• Hydrogen peroxide or saline
• 10 cc syringe
• Brush for debridement (such as the Cook® Fistula Brush)
NOTE: Handle the plug using aseptic technique, minimizing contact with
latex gloves.

PREPARATION

1. Use a sterile probe or other appropriate measuring instrument to
approximate the diameter of the fistula tract at the internal (rectal)
opening. Select the proper plug size according to the table below.
Diameter of Internal
Fistula Opening
> 1 mm to 2 mm
> 2 mm to 4 mm
> 4 mm to 7 mm
2. Using aseptic technique, open the outer pouch and pass the inner pouch
containing the plug onto the sterile field.
3. Open the inner pouch and remove the tray containing the plug. Open the
tray and place the plug into a sterile basin.
4. Add enough hydration fluid to the basin to fully submerge the plug.
Allow the plug to hydrate until the desired handling characteristics are
achieved. Do not hydrate the plug for more than 1 minute.
5. Remove the hydrated plug from the basin using forceps.
6. Attach a silk suture (approximately 30 cm in length) around the tail
(narrow end) of the plug to use as a tether to pull the plug into the fistula
tract.
7. Prepare the patient 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 using
enemas and cathartic agents, and administration of prophylactic oral or
intravenous antimicrobial agents. Insufficient cleansing or inadequate
antibacterial prophylaxis can predispose the patient to infections.
PROCEDURE
1. Perform under local, regional, or general anesthesia.
2. If a seton is not in place, identify the internal (rectal) fistula opening.
NOTE: Failure to locate the internal opening may lead to persistence
of the fistula. If the internal opening cannot be reliably identified, an
alternative treatment method should be considered.
3. Insert a fistula probe, seton, or suitable instrument through the fistula
tract, entering through the external opening and exiting via the internal
opening.
4. Attach the brush to the instrument at the internal opening.
5. If a seton is in place, cut the seton and attach the brush to the seton at
the internal (rectal) opening.
6. Pull the brush into the tract and gently debride to remove non-
vascularized tissue. Do not enlarge the tract.
NOTE: Blood should be noted on the bristles of the brush and at both the
internal and external fistula openings after adequate debridement.
7. Flush the tract thoroughly with hydrogen peroxide or sterile saline using
the 10 cc syringe and 5 Fr catheter.
8. Attach the tether connected to the tail of the plug to the end of the brush
at the internal opening.
• Seroma Formation
• Swelling
Plug Size Plug Part Number
2 mm
4 mm
7 mm
4
C-FP-0.2-2
C-FP-0.4-2
C-FP-0.7-2
6-8