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

November 22, 2015 updated by: Woojin Choi, Severance Hospital

Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Woo Jin Choi, MD
  • Phone Number: 82)2-2228-2195
  • Email: choiwj@yuhs.ac

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days to patient discharge
Time Frame: up to 4 weeks
-Examine the days from applied medical device to discharge.
up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
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)
up to 4 months
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 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
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.
up to 4 months
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.
4 months (at least once a week for 4 weeks / After dischage, every participant visit day(for 3 months))
Days of NPWT application period
Time Frame: up to 8 weeks
-Examine the period of NPWT application
up to 8 weeks
Number of surgical debridement after NPWT
Time Frame: up to 8 weeks
-Examine the number of debridement during applied NPWT
up to 8 weeks
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
up to 4 months
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
up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Severance Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: WooJin Choi, MD, Korea: Severance hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SS-14-NPWT
  • CGBIOW1404 (Other Grant/Funding Number: CGBIO CO., LTD.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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