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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274207
Recruitment Status : Unknown
Verified November 2015 by Woojin Choi, Severance Hospital.
Recruitment status was:  Recruiting
First Posted : October 24, 2014
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Woojin Choi, Severance Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: NPWT application Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT
Study Start Date : December 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: silver dressing
Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea
Device: NPWT application
NPWT mode is cyclic mode : -125~-50 mmHg

Active Comparator: non-silver dressing
Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea
Device: NPWT application
NPWT mode is cyclic mode : -125~-50 mmHg




Primary Outcome Measures :
  1. Days to patient discharge [ Time Frame: up to 4 weeks ]
    -Examine the days from applied medical device to discharge.


Secondary Outcome Measures :
  1. Days to infection clearance in wound culture results [ Time Frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) ]
    • Compare screening culture test with every visit culture test
    • Examine days to infection clearance(point to show bacteria minus level in culture test)

  2. Complete infection clear rate in wound culture results [ Time Frame: up to 4 months ]
    • Compare screening culture test with every visit culture test
    • Examine total complete infection clear rate in each groups. (point to show bacteria minus level in culture test)

  3. Days to complete wound closure [ Time Frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) ]
    -Examine days from applied medical device to wound closure day

  4. Wound closure rate [ Time Frame: up to 4 months ]
    • Examine total wound closure rate in each groups.
    • Wound closure: definition: skin graft, epithelized skin or simple suture et. al.

  5. Elevation of wound evaluations grade [ Time Frame: 4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months)) ]
    • Examine the rate of wound size, wound depth (4 category),granulation tissue grade (5 step),Infection symptom(4 grade)
    • Present wound size, infection grade, depth category, granulation tissue grade at every patient visit and examine elevation of wound evaluations compared with baseline.

  6. Days of NPWT application period [ Time Frame: up to 8 weeks ]
    -Examine the period of NPWT application

  7. Number of surgical debridement after NPWT [ Time Frame: up to 8 weeks ]
    -Examine the number of debridement during applied NPWT

  8. Lab - deviation of level [ Time Frame: up to 4 months ]
    • Compared baseline lab level
    • Examine related infection sign level (white blood cell,monocytes,C-reactive protein)
    • Finding adverse deviation level through the lab level

  9. Rate of adverse event [ Time Frame: up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom ]
    -Examine adverse event every visit



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274207


Contacts
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Contact: Woo Jin Choi, MD 82)2-2228-2195 choiwj@yuhs.ac
Contact: Heiji Han, bachelor 82)10-5086-7812 bohemi_han@naver.com

Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Woojin Choi, MD    82)2-2228-2195    choiwj@yuhs.ac   
Contact: Heiji Han, bechelor    82)2-2228-2195    bohemi_han@naver.com   
Sponsors and Collaborators
Severance Hospital
Investigators
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Principal Investigator: WooJin Choi, MD Korea: Severance hospital

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Responsible Party: Woojin Choi, Orthopedics, Severance Hospital
ClinicalTrials.gov Identifier: NCT02274207    
Other Study ID Numbers: SS-14-NPWT
CGBIOW1404 ( Other Grant/Funding Number: CGBIO CO., LTD. )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015
Keywords provided by Woojin Choi, Severance Hospital:
Silver dressing
NPWT
DMF
foot
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents