clinical efficacy of kaolin-impregnated dressing for ... - hwang...agreed the written consent form...
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Clinical efficacy of Kaolin-impregnated dressing for hemostatic control in diabetic
foot ulcer with anticoagulant therapy undergoing surgical debridement in Outpatient clinic: A prospective, randomized, clinical trial
Yeok Gu Hwang, MD; Eun Ae Won, RN; Jin Woo Lee, MD, PhD; Seung Hwan Han, MD, PhD
Department of Orthopaedic Surgery
Yonsei University College of Medicine, Seoul, Korea
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The authors have no conflicts to disclose.
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Introduction
• Diabetes patients
Receive anticoagulant treatment
Vascular diseases are the chief causes
of death and disability
• After discontinuation of anticoagulation therapy
Cardiovascular Risk ↑ Peri-operative bleeding ↓
• Effectiveness of kaolin-impregnated dressings for trauma and
percutaneous vascular intervention.
Watters JM et al. Journal of Trauma and Acute Care Surgery. 2011
Trabattoni D et al. European radiology. 2011
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Introduction
The purpose of study
to examine the effectiveness, safety, and hemostatic
effect of kaolin-impregnated gauze on diabetic foot
ulcer patients who continue to receive anticoagulants
after surgical debridement
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Patients and Methods
• Between August 2014 ~ March 2016
• Total 20 patients (15 men and 5 women) who surgical debridement
• Conventional manual compression methods using
Dry gauze VS Kaolin-impregnated gauze
• Hemostatic measures at 5 and 10 minute
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Patients and Methods
1. Over 20 years old 2. Type I or II diabetes mellitus(DM) 3. Ulcer Wagner grade I or II ulcer 4. Above 2 cm diameter 5. Without infection or inflammation (local tenderness, erythema,
generalized fever, and leukocytosis) 6. Good extremity circulation status 7. Received anticoagulation therapy 8. Agreed the written consent form
Inclusion criteria
Exclusion criteria
1. Pregnancy 2. Immunosuppressant therapy, systemic cardiopulmonary disease 3. Not agree to this study
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• Hemostatic dressing
– Flexible, non-woven coated gauze impregnated with kaolin construction
• Kaolin Aluminum silicate
Coagulation initiator
Hemostatic effect caused by the activation
of the intrinsic clotting pathway
Product description
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Study Protocol
(A) Devitalized margin of diabetic foot ulcer was debrided with surgical blade
(B) Application of Kaolin-impregnated dressing after soaking to ulcerative wound with sterilized forceps
(C) Compression with constant pressure manually
⒜ ⒝ ⒞
Serial hemostatic procedures on diabetic foot ulcer after surgical debridement
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Control
(n=10, 50.0%)
Study
(n=10, 50.0%) p value
Age (years) 58.9 ± 11.5 68.7 ± 10.8 0.065
Gender (male : female) 8 : 2 7 : 3
Body mass index, kg/m2 24.6 ± 2.7 24.1 ± 4.3 0.773
Systolic BP (mmHg) 136.0 ± 18.3 134.0 ± 21.2 0.823
Diastolic BP (mmHg) 70.9 ± 11.3 73.0 ± 8.2 0.640
Heart rate (/min) 82.7 ± 12.1 77.1 ± 16.6 0.400
White blood cells (x103/μl) 10.2 ± 3.9 6.5 ± 1.6 0.019
HbA1c (%) 8.8 ± 2.9 7.9 ± 1.4 0.426
Duration of diabetes (years) 15.9 ± 7.5 22.8 ± 12.4 0.157
Smoking 0.470
Non-smoker 8 (80.0%) 5 (50.0%)
Former smoker 1 (10.0%) 5 (50.0%)
Smoker 1 (10.0%) 0 (50.0%)
Demographics
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Control
(n=10, 50.0%)
Study
(n=10, 50.0%) p value
Wagner ulcer classification 0.058
Grade 1 1 (10.0%) 5 (50.0%)
Grade 2 9 (90.0%) 5 (50.0%)
Site 0.791
Forefoot 5 (50.0%) 6 (60.0%)
Midfoot 3 (30.0%) 3 (30.0%)
Hindfoot 2 (20.0%) 1 (10.0%)
Ulcer area (cm2) 19.33 ± 17.39 14.30 ± 9.25 0.431
Demographics
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Control
(n=10, 50.0%)
Study
(n=10, 50.0%) p value
PT (sec: 9.2~12.3*) 12.36 ± 1.37 13.16 ± 1.83 0.283
PT (INR:0.91~1.16*) 1.05 ± 0.11 1.12 ± 0.14 0.227
aPTT (sec:26.8~40.6*) 36.22 ± 22.16 37.15 ± 13.42 0.911
Demographics
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• No evidence of the bleeding in study group within 10 minutes
• Eight of 10 diabetic foot ulcer treated with a Kaolin-impregnated dressing observed complete hemostasis within 5 minutes
• Five of 10 patients in control group, fail to achieve hemostasis in 10 minutes
• Adverse effects were not noted in all patients.
Results
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Conclusion
The use of Kaolin-impregnated dressing appears to be a safe and feasible option in the management of diabetic foot ulcers who had a bleeding tendency is high
Reference Creager MA, Lüscher TF, Cosentino F, Beckman JA. Diabetes and vascular disease pathophysiology, clinical consequences, and medical therapy: part I. Circulation. 2003;108(12):1527-1532. Trabattoni D, Montorsi P, Fabbiocchi F, Lualdi A, Gatto P, Bartorelli AL. A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures. European radiology. 2011;21(8):1687-1691. Braun LR, Fisk WA, Lev-Tov H, Kirsner RS, Isseroff RR. Diabetic foot ulcer: an evidence-based treatment update. American journal of clinical dermatology. 2014;15(3):267-281. Alavi A, Sibbald RG, Mayer D, et al. Diabetic foot ulcers: part II. Management. Journal of the American Academy of Dermatology. 2014;70(1):21. e21-21. e24. Ward KR, Tiba MH, Holbert WH, et al. Comparison of a new hemostatic agent to current combat hemostatic agents in a swine model of lethal extremity arterial hemorrhage. Journal of Trauma and Acute Care Surgery. 2007;63(2):276-284.