Servizio di Angiologia
e Ambulatorio per la diagnosi
e cura delle ulcere vascolari
degli arti inferiori
ASL 10 Firenze -


  Servizio di Angiologia
e Ambulatorio per la diagnosi
e cura delle ulcere vascolari
degli arti inferiori
ASL 10 Firenze -  

cell. 338-2518571

Ambulatorio I.O.T. (Istituto Ortopedico Toscano) - Firenze 055-6577269 (viale Michelangelo, 41)

 

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