Clinical trial NCT02274207: Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound
Official title: Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Keywords: Silver dressing
NPWT
DMF
foot
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 infected diabetes mellitus foot.

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. 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.

Eligibility criteria: Inclusion Criteria:

* The patient above 20 years and has type I, II of diabetes mellitus foot ulcer
* 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:

* 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.

Primary outcomes:
measure: Days to patient discharge
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Days to infection clearance in wound culture results
timeFrame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
measure: Complete infection clear rate in wound culture results
timeFrame: up to 4 months
measure: Days to complete wound closure
timeFrame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
measure: Wound closure rate
timeFrame: up to 4 months
measure: Elevation of wound evaluations grade
timeFrame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
measure: Days of NPWT application period
timeFrame: up to 8 weeks
measure: Number of surgical debridement after NPWT
timeFrame: up to 8 weeks
measure: Lab - deviation of level
timeFrame: up to 4 months
measure: Rate of adverse event
timeFrame: up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Korea: Severance hospital
name: WooJin Choi, MD
role: PRINCIPAL_INVESTIGATOR
References: