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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
NPWT mode is cyclic mode : -125\~-50 mmHg
Severance Hospital
Seoul, Seoul, South Korea
RECRUITINGDays to patient discharge
-Examine the days from applied medical device to discharge.
Time frame: up to 4 weeks
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)
Time frame: 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)
Time frame: up to 4 months
Days to complete wound closure
-Examine days from applied medical device to wound closure day
Time frame: 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.
Time frame: 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.
Time frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
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Days of NPWT application period
-Examine the period of NPWT application
Time frame: up to 8 weeks
Number of surgical debridement after NPWT
-Examine the number of debridement during applied NPWT
Time frame: 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
Time frame: up to 4 months
Rate of adverse event
-Examine adverse event every visit
Time frame: up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom