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

The authors have no conflicts to disclose.

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

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

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

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

• 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

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

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

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

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

• 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

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.