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Ozonated Oil Research from Japan

Intractable Fistula

Therapeutic Effects of Ozonized Olive Oil in the Treatment of
Intractable Fistula and Wound after Surgical Operation
Akiyo Matsumoto1, Shotaro Sakurai2, Nariko Shinriki3,Shigeru Suzuki4
and Toshiaki Miura5

1Department of Surgery, Chiba-Tokushukai Hospital,
Narashino-dai, Funabashi, 274-8503, Japan

2Department of Pharmacy, Kashiwa Municipal Hospital, Fuse, Kashiwa, 277-0825, Japan

3Tsukuba Materials Information Laboratory, Sapporo Branch, Sapporo, 062-0906, Japan

4Nippon Ozone Co. Ltd., Arakawa 7-4-3, Tokyo, 116-0002, Japan

5College of Medical Technology, Hokkaido University, Kita-ku, Sapporo, 060-0812, Japan

Abstract
20  patients  at  several  hospitals who underwent surgical operation between August
1998 to August 2000 had ozonized olive oil applied to their intractable fistula or
wounds. The ozonized olive oil treatment was fully effective in 19 of the cases. The
one exception was for a case of pilonidal sinus. Ozonized olive oil was especially
effective in treating intractable abdominal fistula to digestive tract after surgical
operation. No adverse side effects were observed in the administration of the
ozonized olive oil. It was fully effective for a discharge of pus and the formation of
granulation.

Introduction
There have been many cases of intractable fistula forming after surgical operations. In Europe
ozonized olive oil has been used to treat serious wounds and good results have been achieved,
however it has almost never been used in clinical applications in Japan. We started to test
ozonized olive oil by treating intractable wound which resulted in a cure. Since then we have
applied it for many kinds of cases, e.g., intractable fistula, decubitus anal fistula, pilonidal
sinus and so on. We will report good results we achieved.
Materials and Methods
The main component of ozonized olive oil was found to be triolein triozonide as explained in
the proceeding presentation..
Refrigerated ozonized olive oil which was obtained from Pharmoxid, Germany was brought
to a viscous state at room temperature before use.
20 patients who had been treated unsuccessfully for intractable fistulas and wounds were
selected. These patients had previously been treated by curettage, saline deterge, antibiotic
ointment and/or drainage. Before treatment with ozonized olive oil an informed consent form
was obtained.Pus from the intractable fistulas and wounds was discharged and the ozonized oil was
administered to the opening by a 1.0 or 3.0 ml syringe. After the application of the ozonized
oil the fistula or wound was loosely covered by gauze. In some cases excess pus was
produced so a saline deterge was used, and debridement was done in cases of necrosis. There
was no administration of antibiotics either externally or orally, nor were the fistulas or wounds
stuffed with gauze or drained.

Results
20 cases are shown in Table 1. The number of other treatments before the ozonized oil (saline
deterge, antibiotic ointment, curettage and drainage) and the interval between treatments is
shown on the center. In the right columns we show the number of treatments of the ozonized
oil, dosage volume and intervals of application until the patient was cured.
There were three cases of intractable fistula after operation for inguinal hernia, including one
case of intractable fistula with infected mesh (case 2), which was cured by only 5 applications
of the ozonized oil.
Four cases of intractable fistula after operation for acute appendicitis with peritonitis (case 4
to 7) had difficulty in closing the opening, but after using the ozonized oil for only 3 to 10
applications they were cured. Photo.1 shows case 4 pre and post the ozonized oil treatment.
Five cases of intractable wound after operation for infected epidermal cyst were also shown.
Case 11 needed 24 applications but the others soon recovered. Photo. 2 shows case 10 pre and
post the ozonized oil treatment.
One case (case 13) was fistula after incision to treat an infected urachal cyst. Excretion of pus
was limited but the incision wound did not easily close after the operation. However after
only 3 treatments with the ozonized oil it closed.
We treated three cases of fistula after incision and drainage for infected pilonidal sinus. In
case 19 the number of treatments was higher than usual but a cure was effected. Case 17 had a
3 cm diameter abscess cavity under the skin that was not cured despite many applications of
the ozonized oil.
In a case of lower limb ulceration due to sunburn (case 20), a patient had a 3.0cm diameter
blister . Following usual practice the blister was pricked and treated, however the abscess
belaque at the bottom of the ulcer did not disappear. After application of the ozonized oil pus
solidification and a drying up at the ulcer bottom started and epithelization appeared, and then
the ulcer cured. This is shown in Photo. 3.
We treated three cases of fistula after incision and drainage for perianal abscess (cases 14 to
16), including one case for periviorectal abscess (case 15). We showed the cure proceedings
of case 15 in Photo. 4.  Abscess cavities were formed in the range of 1) ischiorectal fossa on
the right, 2) internal and external obturator muscles on the left, 3) piriform muscles, 4) a part
of maximum gluteal muscle. A patient had a fever over 38°C and an increase of leukocyte
(15,200/mm3). After repeated incisions and drainage for perianal abscess, a decrease of
excretion of pus occurred and on the 8thday from the operation the patient started to eat.
However he again had a fever of 38°C  and an increase in the amount of pus. We were forcedto control his condition by fasting. We found Alpha Streptococcus in his pus. 20 days after the
operation we started to treat his fistula with the ozonized oil, then the administration of oral
antibiotics became unnecessary. On the 14th
day of treatment with the ozonized oil he started
to have meals without a fever nor an increase in leukocyte although a small amount of pus
was excreted. Photo. 4-B is a X-ray using diatorizonate sodium and shows the intractable
fistula at the start for the ozonized oil treatment. Photo. 4-D shows the fistula after 18
applications of the ozonized oil, and only ramiform fistula remained in the range of 1)
ischiorectal fossa on the right and the back of the rectum. In the CTs (4-E1~E3) abscess
formation could not be found. On the incised part of the right side around the anus a fistula
into which a sonde could only be inserted 2 cm remained and there was no excretion of pus.
From then the patient became an outpatient and until now there has been no sign of
recurrence.

Discussion and Conclusion
We often see intractable fistulas and wounds as a result of surgical operation. In the treatment
of intractable fistulas, use of local applications of Picibanil, fiblin paste and/or medicine made
from human blood coagulation factor 8, high oxygen pressure treatment and laser beam
irradiation method have been reported.
1)-5)
Operation for inguial hernia often gives rise to
infected mesh ( case 2 ) resulting in the need for a second operation. The infection is initially
cured but soon gets re-infected causing a repeat hernia.  In operations for acute appendicitis
with diffuse  peritonitis the formation of intractable fistula is often seen

6). Even in cases of
relatively simple fistula observed by X-ray diatorizoate sodium treatment becomes very hard
due to the difficulty in overcoming infection and the elimination of bad granulation. In cases
of infected epidermal cyst, incision to eliminate pus often causes the infection to spread and
consequently subcutaneous tissue is lost, increasing the difficulty in curing the wound.
We tried treating intractable fistulas and wounds with the ozonized oil, which is especially
easy to apply without any special instrument. The application of the ozonized oil decreased the
excretion of pus along with a corresponding increase in granulation at the rim of the wound.
Then the opening reduced to a pin point or line state, and finally the excretion of pus stopped
and the fistula closed. In cases of fistula with minimal excretion of pus, epithelization of the
opening parts and subsequent closing were rapid. Infected urachal cysts and infected pilonidal
sinuses which are not cured by antibiotics
7)
usually need radical operations, however in our
study they were seen to be effectively cured by the ozonized oil. Anal fistulas, which are
easily formed after incision and drainage for perianal abscesses often need a radical operation,
but cases 14 and 16 soon healed after application of the ozonized oil, and  there has been no
sign of recurrence. In case 15 a periviorectal abscess showed a rapid reduction of fistula size
and a tendency to heal. Until now, after debriedment intractable fistulas and wounds were
classified by their conditions and their treatment was carried out according to this
classification. Wounds with large amounts of pus had saline deterge, drainage and local
application of antibiotics. After the granular formation some drugs which promote the
formation of granulation was used. Using the ozonized oil by itself resulted in pus
solidification, an ocurrence of drying, the appearance of epithelization and a decrease in the
size of abscesses. The fistulas and wounds had a tendency to cure; therefore the ozonized oil
itself can cure these independently.  Intractable wounds that had a certain degree of
granulation after debriedment of the parts of necrosis and abscess had the ozonized oil applied
and this resulted in rapid epithelization and a closing of the opened wounds.The disinfection effect of ozonized olive oil has already been reported8)
.

On the other hand the
stimulation mechanism of the ozonized oil to the tissue (e.g., granulation and epithelization
etc.) has not been clarified enough. However, in ozone treatment (e.g., autohemotherapy)
ozone has been recognized to have some stimulating effects on leukocytes, e.g., induction of
many cytokines was clearly confirmed by Bocci
9,10)
. In ozone gas rinsing of ulcers caused by
arterial circulation disorders (diabetes), increases of granulation tissue and epidermal
epithelium were observed by Rokitansky11)
. Also in the case of ozonized olive oil some active
oxygen species which are considered to be generated from the breakdown of triolein
triozonide will be able to react and/or stimulate the cells. About this point more study will be
needed.
In conclusion we think that because of its good results with no side effects and ease of
application ozonized olive oil should be used for the treatment of intractable fistulas and
wounds after surgical operations.
References
1) Nakanishi Y, Nakajima T, Yoshimura Y et al.: Nihon Keisei-geka Gakkai Kaishi (J. Japan
Soc. Plastic and Reconstructive Surgery) 17: 428-433, 1997
2) Hiraguchi E, Miyake Y, Sunaga M et al.: Nihon Rinsyo-geka Gakkaishi (J. Japan Surgical
Assoc.) 53: 209-214, 1992
3)Usui A, Kubota M, Ohkita J et al.: Hinyouki-geka (Japanese J. Urological Surgery) 6 : 373-
376, 1993
4) Kawashima M, Tamura H, Takao K et al.: Nihon Iji Shinpou (Japan Medical Journal)
No.3525 : 43-45, 1991
5) Suguro M, Ejiri S, Sakashita T : Shohkaki Naishikyo (Endoscopia Digestiva) 9 : 411-416,
1997
6) Yamamoto S, Watabe T, Matsumoto Y et al.: Geka (Surgery) 57 : 149-154, 1995
7) Lundhus E, Gottru F : Outcome at three to five years of primary closure of perianal and
pilonidal abscess. A randomised, double-blind clinical trial with a complete three-year
follow up of one compared with four days’ treatment with ampicillin and metronidazole.
Eur. J. Surg. 159 : 555-558, 1993
8) Lezcano I, Nuñez N, Espino M, Gómez M : Antibacterial activity of ozonized sunflower
oil, Oleozón, against Staphylococcus aureus and Staphylococcus epidermidis. Ozone Sci.
Eng. 22 : 207-214, 2000
9) Bocci V, Paulesu L : Studies on the biological effects of ozone. 1; Induction of interferon
γ  on human leucocytes. Haematologica 75 : 510-515, 1990
10) Paulesu L, Luzzi E, Bocci V: Studies on the biological effects of ozone. 2; Induction of
tumor necrosis factor (TNF-α) on human leucocytes. Lymphokine Cytokine Res. 10, 409-
412, 1991
11) Werkmeister H : Subatomospheric O2/O3-treatment of therapy-resistent wounds and
ulcerations. OzoNachrichten 3/4, 53-59, 1985Table I  The breakdown of 20 cases of serious post operation fistulas and wounds

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