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Patients & Methods 2012 December ~ 2013 December
Institutions: Inha University Hospital, Severance Hospital, Ilsan Hospital N=61 cases (56 patients) Inclusion criteria Age 18~65 High-energy foot & ankle Fx 61 cases (56 patients) Calcaneus: 27 Trimalleolar: 22 Pilon: 9 Talus & distal tibia: 3 Control group (n=32) Conventional gauze dressing Test group (n=29) Dressing with Incisional NPWT
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Application -125 mmHg Continuous mode Duration : 72hrs
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Vascular problem (Bleeding tendency)
Demographic Data NPWT (N=29) Control (N=32) P value Smoking 9 (31%) 12 (37.5%) 0.74 Alcohol 14 (48.2%) 18 (56.2%) 0.92 Diabetes 5 (17.2%) 3 (9.4%) 0.95 HTN 6 (20.7%) 8 (25%) 0.81 Vascular problem (Bleeding tendency) 1 (3.4%) 1 (3.1%) 1 Mean BMI 23.22 24.95 0.58 Incision length(cm) 14.2 14.6 0.46
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Distribution of Fracture Type
NPWT (N=29) Control (N=32) Total Trimalleolar 9 (31%) 13 (40.6%) 22 (36.1%) Pilon 5 (17.2%) 4 (12.5%) 9 (14.7%) Calcaneus 14 (48.3%) 27 (44.3%) Talus and distal Tibia Fx. 1 (3.4%) 2 (6.2%) 3 (4.9%)
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Initial Application Cases Control Incisional NPWT
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Postoperative Day 1 Control Incisional NPWT
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Postoperative Day 3 Control Incisional NPWT
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Postoperative Day 14 Control Incisional NPWT
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Complications Associated with The Dressings - maceration, erythema, skin irritation sign
(Complications: maceration, erythema, skin irritation sign) NPWT (N=29) Control (N=32) P value POD 1d 5 10 0.342 POD 3d 9 0.468 POD 14d 1 2 0.42
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Final Results at Postoperative Day 14
NPWT (N=29) Control (N=32) P value Infection 3 0.146 Dehiscence 5 0.035 Cosmetic evaluation 7.31/10 6.23/10 0.23
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Swelling Reduction Effective in rapid decrease of swelling
Mild Moderate Severe Pre-OP P = 0.005 : Repeated measured 2- way ANOVA test Effective in rapid decrease of swelling Effective in rapid decrease of swelling
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Trial Summary Effects of Incisional NPWT Conclusion
Decreases swelling more rapidly (p<0.05). Reduces wound dehiscence (p<0.05). Effects on Postop wound infection – Show reduction but not statistically significant Conclusion Helpful in reducing postoperative wound problems in high energy foot & ankle trauma.
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On-Going Clinical Trials
No Product Indication Study duration Target Enrolled Progress 1 KulaVAC DM foot 20 16 80% 2 50 37 74% 3 10 7 70% 4 Pressure Ulcer 30 19 63% 5 Incisional Wound 100% 6 0% 8 40% 9 KulaVAC-Silver 22 86% 91% 11 21 95% 12 KulaVAC-Bridge 25% 13 Burn ND 14 KulaVAC + CGDerm FTSG 15 Trauma 10% 17 Donor site 40 18
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KulaVAC® Marketing Representative
in China Daewoong Pharmaceutical Co.,Ltd. China 金正煥 (Kim Jung Hwan) Tel : Fax : Mobile : (CHI) , (KOR) Room 2208B, East Tower of Twin Towers, No.B12, JianGuoMen Wai Avenue, ChaoYang District, Beijing, China 北京市朝阳区建国门外大街乙十二号双子座大厦东塔2208B
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Thank you
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KulaVAC® Publications
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