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

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: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: NPWT application

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: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Recruiting
    • Severance Hospital
    • Contact: Woojin Choi, MD; Phone Number: 82)2-2228-2195; Email: choiwj@yuhs.ac
    • Contact: Heiji Han, bechelor; Phone Number: 82)2-2228-2195; Email: bohemi_han@naver.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to patient discharge	-Examine the days from applied medical device to discharge.	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days to infection clearance in wound culture results	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	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	-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	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	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	-Examine the period of NPWT application	up to 8 weeks
Number of surgical debridement after NPWT	-Examine the number of debridement during applied NPWT	up to 8 weeks
Lab - deviation of level	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	-Examine adverse event every visit	up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom

Collaborators and Investigators

• Sponsor: Severance Hospital
• Investigators: Principal Investigator: WooJin Choi, MD, Korea: Severance hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): November 24, 2015
• Last Update Submitted That Met QC Criteria: November 22, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: NPWT; foot; Silver dressing; DMF
• Other Study ID Numbers: SS-14-NPWT; CGBIOW1404 (Other Grant/Funding Number: CGBIO CO., LTD.)