COOK Medical Biodesign Mode D'emploi page 5

3. Using a syringe and short catheter, gently clean the fistula tract as
thoroughly as possible by flushing the tract with hydrogen peroxide
or sterile saline, or debride using a brush or similar instrument. Do not
enlarge the tract.
4a. If a seton is not in place, insert a fistula probe, seton, or suitable
instrument through the fistula tract, entering through the external
(secondary) opening and exiting via the internal (primary) opening.
Attach the suture connected to the plug to the instrument at the internal
(primary) opening end.
4b. If a seton is in place, cut the seton and attach the suture to the seton at
the internal (primary) opening end.
5. Draw the tie attached to the 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. Do not use the entire plug unless
the tract is the full length of the plug.
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.
6. When the plug is properly positioned, trim away and discard any remaining
portion of the plug that is not implanted within the fistula tract.
IMPORTANT: The plug should be trimmed at the level of the bowel wall
at the internal opening in order to minimize contact with bowel contents.
7. Suture the internal (primary) end of the plug in place with suitable
resorbable suture. Refer to the illustrations. Suture the internal end of the
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.
NOTE: There should be no part of the plug visible at the internal (primary)
opening.
NOTE: If the internal (primary) opening is dimpled or recessed, consider
limited mobilization of the mucosal edges prior to suture placement to
ensure adequate coverage of plug.
NOTE: Inadequate fixation of the plug to the deep tissue layers may result
in early recurrence of the fistula.
8. The excess external plug should be trimmed flush with the skin without
fixation. The external (secondary) opening may be enlarged to facilitate
drainage.
NOTE: 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.
10. Discard any unused portions of the device following standard technique
for disposal of medical waste.
SIDE VIEW
TOP VIEW
POST-OPERATIVE CARE
To provide the best environment for tissue integration into the plug, patient
activity should be minimized. Provide patients with a list of post-procedure care
recommendations. The following patient guidelines should be considered.
1. No strenuous activity for two weeks.
2. No lifting items over 10 lbs (5 kg) for two weeks.
3. No exercise beyond a gentle walk for two weeks.
4. Abstinence from sexual intercourse and other forms of vaginal/rectal
insertion (i.e. tampons) for at least two weeks.
5. Shower standing up and bathe the area with water to soothe and keep it
clean.
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