Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound (NPWT-silver)

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus

Treatments: Device: NPWT application

Study type: Interventional

Funder types: Other

Identifiers

NCT02274207

SS-14-NPWT

CGBIOW1404 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

silver dressing

Experimental group

Description:

Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea

Treatment:

Device: NPWT application

non-silver dressing

Active Comparator group

Description:

Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea

Treatment:

Device: NPWT application