Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound
NCT ID: NCT02274207
Last Updated: 2015-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
74 participants
INTERVENTIONAL
2014-12-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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silver dressing
Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea
NPWT application
NPWT mode is cyclic mode : -125\~-50 mmHg
non-silver dressing
Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea
NPWT application
NPWT mode is cyclic mode : -125\~-50 mmHg
Interventions
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NPWT application
NPWT mode is cyclic mode : -125\~-50 mmHg
Eligibility Criteria
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Inclusion Criteria
* Infected ulcer has one of below.
1. clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling
* induration, purulent discharge etc.
2. Confirmed case of bacteria in wound culture.
3. 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
* 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.
20 Years
ALL
No
Sponsors
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Severance Hospital
OTHER
Responsible Party
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Woojin Choi
Orthopedics
Principal Investigators
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WooJin Choi, MD
Role: PRINCIPAL_INVESTIGATOR
Korea: Severance hospital
Locations
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Severance Hospital
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CGBIOW1404
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SS-14-NPWT
Identifier Type: -
Identifier Source: org_study_id