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HYDROGEL IN COMBINATION WITH POVIDONE IODINE IN THE TREATMENT OF INFECTED DIABETIC/ARTERIAL ULCERS
NEW APPROACHES TO THE
MANAGEMENT OF CHRONIC WOUNDS, MILAN, ITALY.
Study type: case reports, clinical evaluation.
Poster presentation
Authors:
R. Polignano*, MD., P.L. Vannucchi, MD, Monaldi, MD, R. Sassi, MD, S. Rowan**,
RN, CNS.
* Internal Medicine and Angiology Department, Santa Maria Nuova Hospital -
Florence, ITALY
** San Casciano, (FI), ITALY
key words: - infection in diabetic foot ulcers - topical anti-septics - debridement of infected wounds
INTRODUCTION
This paper describes the treatment of twenty patients with infected diabetic
foot ulcers using a combination of a hydrogel* with Povidone-Iodine ointment.
Diabetic and arterial leg ulcers that show resistance to systemic and topical
treatment are often characterized by frequent infections. Systemic antibiotics,
due to the specific pathology may not be effective. Long term use of antibiotics
is known to cause complications.(1) The use of topical anti-septics may support
treatment of these infections.(2)(3) The clinical efficacy of antiseptics in the
management of infected wounds has been challenged by a number of experimental
studies. Particularly the cytotoxicity of Iodine has been argued against.(5).
The important factor in iodine toxicity might be oxygen tension. Therefore
cytotoxicity studies may be irrelevant, as in the actual clinical situation the
same chemical may have different effects, depending on wheter or not the wound
was hypoxic. The possibility that non-toxic levels iodine have potentially
beneficial bio-activity was raised by in vitro studies reported by Keith Moore
(Cardiff, UK). Dr. Moore reported that 0.25% cadexomer iodine (0.00225% iodine)
enhanched the production of tumor necrosis factor (TNF-a) from macrophages
co-stimulated with suboptimal levels of bacterial lipopolysaccharide. This
effect was not seen with the addition of cadexomer carrier alone, indicating
that the effect was mediated by the iodine component. (6). The combination of a
hydrogel* with Povidone Iodine may allow the gel to act as a carrier of the
antiseptic, enabling transportation into the deeper layers of the tissue.
MATERIALS AND METHOD
All 20 cases were presented with extensive ulcers with clinical signs and
symptoms of infection. Wound cultures showed among others Pseudomonas Aeruginosa
and Staphylococcus Aureus. Systemic antibiotic treatment in combination with
various topical treatments, such as hydrocolloids, enzymes, hydrogels and
alginates did not improve the condition of the wound within six months. Clinical
signs and symptoms of infection as well as a positive wound culture showed that
the infection was still present. Some patients complained of increased pain and
there was a lot of necrotic tissue present in the ulcers. We mixed a hydrogel
and Povidone-Iodine ointment, applied it on the ulcers, covering them with a
polyurethane film*. Dressing changes took place three times a week. The patients
were treated on an out-patient basis. Weekly wound assessment took place and a
wound culture was taken (curette technique) from the wound bed and - edges.
RESULTS
After the treatment regime was changed to the above described mix of hydrogel
and Povidone-Iodine, within four weeks the ulcers were debrided and bacterial
load was reduced. Complete healing was achieved within four months. Three cases
are described to illustrate our findings.
CONCLUSIONS
The positive results obtained with the above described treatment, suggests that
the gel acts as a carrier for the Povidone-Iodine enabling transportation into
the deeper layers of the tissue. The combination of a hydrogel, providing a
controlled moist environment, enhancing debridement (4) and the local activity
of the disinfectant (2) may explain the obtained results. A preliminary study on
quantitative bacteriology as well as measuring iodine concentrations vertically
through the wound is currently conducted to confirm our clinical results. A DXS
technique, for the non-invasive evaluation of trace-elements in external tissues
by x-ray fluorescence, is used to test the in-vivo pharmacokinetics of the
Povidone-iodine absorbed in the skin.(7).
CASE 1
A 59- year old man suffering from various pathologies such as: Diabetes (non
insulin dependent), anemia, hypertension, slight cardiac insufficiency and a
duodenal ulcer. A CT scan and NMR diagnosed a liver cyst of mixed content, which
was defined not malignant. Medication consisted of: Lasix, Enapren, Trental,
Mepral, Cytotec, Sucramal and multi-vitamins. Photoplethysmography (PGG),
Sonography and Doppler was carried out, the Ankle Brachial Index in both legs
was 1.1. Although he had arterioscleroses of the femoral iliac aorta, he did not
show signs of venous insufficiency or oedema. From November 1995 onwards he
suffered from post traumatic ulcers. For a few months he had very painful, deep
sloughy ulcers on the external malueolus of both legs. The ulcers were infected
and wound edges were hypertrophic. On the posterior side, the tendons were
exposed. Wound cultures (curette technique) were positive and showed high counts
of Pseudomonas Aeruginosa, Serratia m. and Gram positive Staphylococcus Aureus.
He received both systemic and topical antibiotics. Frequent dressing changes
were carried out for 3 months. The various dressing regimes consisted of
hydrocolloids, enzymes and hydrogels. The dressing regime was effective with
regards to the debridement of black necrosis, but showed poor results on the
sloughy tissue. The severe pain and infection were not resolved.
At the end of January 1996 the patient was hospitalized for a skin graft on his
right leg ulcer. The graft took for 70% and he was discharged after 3 months of
stay in the hospital. At the end of April he was referred to our clinic with a
malodorous ulcer in the graft area. The patients hygiene was very poor. The
dressing regime varied from Iruxol, hydrocolloids, with poor results. Both
ulcers on right and left leg were infected, systemic antibiotics were started. A
month later the ulcers on both legs were necrotic and edema was present. On the
15th of June surgical debridement was carried out on the right leg ulcer. The
dressing regime was changed to a hydrogel* covered with a polyurethane film*
dressing. Around both ulcers cortisone cream was applied to treat inflammation.
This treatment was continued for 1,5 months, during which period the wound
cultures taken, remained positive for the same specimen as mentioned in the
first culture.
At this point the dressing regime was changed as follows: Cleansing with
Ringer’s Lactate solution, after which the wound was rinsed with Povidone
iodine. IntraSite Gel mixed with Povidone-Iodine ointment was applied, covered
with a polyurethane film*. Dressing changes took place every other day. Local
and systemic antibiotics were discontinued. The condition of both ulcers
improved significantly. The infection was resolved, granulation tissue
developed. When epithelium appeared the dressing regime was changed to paraffin
gauze or Allevyn*, depending on the amount of exudate that was produced. At the
end of October both ulcers were completely healed.
The patients hygienic condition had improved at
this point.
CASE 2
A 64 year old patient presented at the end of June 95 at our clinic, with a very
deep ulcer on her left lower limb. The size of the ulcer was approximately 100
cm². The patient was compliant and her hygienic condition was acceptable. A
wound culture (curette technique) demonstrated a high count of Pseudomonas
Aeruginosa of a resistant specimen. Photoplethysmography (PGG) and Doppler was
carried out and did not demonstrate arterial- or venous insufficiency. A biopsy
confirmed necrotizing vasculitis (superficial perivascular dermatitis, with the
presence of platelets CD4+, CD25+ and elements of CD 1a+).
The ulcer was reported to be very painful, covered with sloughy- and black
necrotic tissue and the tendons were exposed. Treatment with systemic and local
antibiotics was started. The various dressing regimes consisted of a calcium
alginate and a hydrogel* covered with a polyurethane film* dressing. Dressing
changes took place every second day. The condition of the ulcers deteriorated
and the pain and infection persisted. As capillary bleeding occurred the ulcer
was additionally treated with Spongostan#.
Complete debridement was achieved and the pain was reported to decrease, however
the dimensions of the ulcer remained the same. A wound culture showed positive
results with regards to the same specimen as reported in the first culture.
Systemic antibiotics and topical treatment with various dressing regimes, such
as enzymes and hydrogels continued and showed poor results.
In October 1995 the dressing regime was changed as follows: Cleansing with
Ringer’s Lactate solution, after which the wound was rinsed with Povidone
iodine. IntraSite Gel mixed with Povidone-Iodine ointment was applied, covered
with a polyurethane film*. Dressing changes took place every other day. Local
and systemic antibiotics were discontinued. The condition of the ulcer improved
significantly. The infection was resolved, granulation tissue developed. In May
1996 the ulcer had completely healed.
CASE 3
A 77 year-old woman, with middle stage of arterial disease, Winsor index 0.6,
diabetes (non insulin dependent) and hypertension, presented with a painful
ulcer on her left heel. Her medication consisted of Lasix, Capoten and Lanoxin.
Blood count for platelets was 496.000. A wound culture (curette technique)
showed positive results with high counts of Pseudomonas Aeruginosa and
Staphylococcus Aureus. The wound edges were red and edema of the foot was
present.
The various dressing regimes consisted of the following: Iruxol+, covered with a
hydrocolloid^ and Paraffin gauze in combination with Iruxol. The patient
received intravenous antibiotics (Glazidin, Ceftazidine, Glaxo).
After 7 months the dressing regime was changed as follows: Cleansing with
Ringer’s Lactate solution, after which the wound was rinsed with Povidone
iodine. IntraSite Gel mixed with Povidone-Iodine ointment was applied, covered
with a polyurethane film*. Dressing changes took place every other day. Systemic
antibiotics were discontinued. The wounds were assessed and a wound culture was
taken once a week. 4 Months after the last dressing regime was started the ulcer
had completely healed.
REFERENCES
1) Thomas S., Wound management and dressings, The Pharmaceutical press 1990,
p.20 - 24.
2) Hunt T.K., 5th ETRS Conference 1995, Padova, Italy, Disinfectants,
Antiseptics, and Antibiotics.
3) Trengrove N. J. et al, 4th EWMA Conference 1994, Macmillan, Qualitative
Bacteriology and Chronic Ulcer Healing. pp. 21
4) Ricci, E., et al, 6th EWMA Conference 1996, Macmillan. Treatment of necrotic
tissue with IntraSite Gel.
5) Rodeheaver G, Bellamy W, Kody M et al, “Bacterial activity and toxicity of
iodine-containing solutions in wounds” Arch Surg 1982; 117: 181-186.
6) ETRS Consensus Meeting, Iodine Revisited, ETRS Bulletin, 1997; 4-1: 6-9.
7) Gorodetsky R, Radiobiology lab., Sharett institute of Oncology, Hadassah
University Hospital, POBox 12000, Jerusalem 91120, Israel.
* IntraSite Gel and OpSite Flexigrid, are products of Smith + Nephew Ltd.
# Spongostan is a product of Johnson & Johnson.
^ Comfeel is a product of Coloplast.
+ Iruxol is a product of Knoll