Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound

Study Overview
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Brief Summary
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The purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in NPWT(Negative pressure wound therapy). Silver dressing may antibacterial effect on infected diabetes mellitus foot.

Detailed Description
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Investigator will recruit sixty patients. Participant will be randomly assigned to one of two groups. One is using silver dressing group in NPWT, another is using non-silver dressing group in NPWT. Participant will visit in screening day, NPWT apply day and F/u day for 4 months. Investigators will conduct to check the wound base, Lab, wound culture.

Official Title
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Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: NPWT application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient above 20 years and has type I, II of diabetes mellitus foot ulcer Infected ulcer has one of below. clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling induration, purulent discharge etc. Confirmed case of bacteria in wound culture. Conformed case of abnormal range of erythrocyte sedimentation rate (ESR)/C-reactive protein(CRP) level in lab. Has to be applied NPWT because suture is impossible in ulcer area. The patient voluntary agreed to this protocol. In the opinion of investigator, It is suitable to participate in this study. Exclusion Criteria: Infection in bone so patient need amputation Female with childbearing, lactating or not agree to prevent pregnancy. Has Sepsis, Osteomyelitis Has Connective tissue disease of disturbance of healing of wound Ex) Rheumarthritis,systemic lupus erythematosus(SEL), myalgia. The patient to diagnosis of Sickle sell disease or Charcot's joint. The patient stability treated chronic wasting disease. Malignant tumor or history of malignant disease. (Not diagnosis of complete recovery.) The patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy. Although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea. Has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic. In case of using prohibited concomitant medications during study. a. Oral system steroid b. Immune-suppressive drug c. Unfractionated heparin infusion d. improper drugs in the opinion of investigator. Hypersensitivity with applicators. (NPWT, Silver) The patient participated in other clinical trials within 30 days In the opinion of investigator, the patient is not suitable to participate in this study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver dressing<br>Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea | Device: NPWT application<br>* NPWT mode is cyclic mode : -125 -50 mmHg<br>|
| Active Comparator: non-silver dressing<br>Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea | Device: NPWT application<br>* NPWT mode is cyclic mode : -125 -50 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to patient discharge | -Examine the days from applied medical device to discharge. | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days to infection clearance in wound culture results | Compare screening culture test with every visit culture test Examine days to infection clearance(point to show bacteria minus level in culture test) | 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) | 
| Complete infection clear rate in wound culture results | Compare screening culture test with every visit culture test Examine total complete infection clear rate in each groups. (point to show bacteria minus level in culture test) | up to 4 months | 
| Days to complete wound closure | -Examine days from applied medical device to wound closure day | 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) | 
| Wound closure rate | Examine total wound closure rate in each groups. Wound closure: definition: skin graft, epithelized skin or simple suture et. al. | up to 4 months | 
| Elevation of wound evaluations grade | Examine the rate of wound size, wound depth (4 category),granulation tissue grade (5 step),Infection symptom(4 grade) Present wound size, infection grade, depth category, granulation tissue grade at every patient visit and examine elevation of wound evaluations compared with baseline. | 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) | 
| Days of NPWT application period | -Examine the period of NPWT application | up to 8 weeks | 
| Number of surgical debridement after NPWT | -Examine the number of debridement during applied NPWT | up to 8 weeks | 
| Lab - deviation of level | Compared baseline lab level Examine related infection sign level (white blood cell,monocytes,C-reactive protein) Finding adverse deviation level through the lab level | up to 4 months | 
| Rate of adverse event | -Examine adverse event every visit | up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Silver dressing, NPWT, DMF, foot