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Clinical Trials/NCT02274207
NCT02274207
Unknown
Phase 4

Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT

Severance Hospital1 site in 1 country74 target enrollmentStarted: December 2014Last updated:
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ConditionsDiabetes Mellitus

Overview

Phase
Phase 4
Enrollment
74
Locations
1
Primary Endpoint
Days to patient discharge
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 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.

Outcomes

Primary Outcomes

Days to patient discharge

Time Frame: up to 4 weeks

-Examine the days from applied medical device to discharge.

Secondary Outcomes

  • Number of surgical debridement after NPWT(up to 8 weeks)
  • Rate of adverse event(up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom)
  • Complete infection clear rate in wound culture results(up to 4 months)
  • Days to infection clearance in wound culture results(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))
  • Wound closure rate(up to 4 months)
  • Lab - deviation of level(up to 4 months)
  • Days to complete wound closure(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))
  • Days of NPWT application period(up to 8 weeks)
  • Elevation of wound evaluations grade(4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Woojin Choi

Orthopedics

Severance Hospital

Study Sites (1)

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