Status:
UNKNOWN
Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound
Lead Sponsor:
Severance Hospital
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
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 inf...
Detailed Description
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. Pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02274207
Start Date
December 1 2014
End Date
August 1 2016
Last Update
November 24 2015
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752