Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound

Diabetes Mellitus Clinical Trial

— NPWT-silver  

Official title:

Phase IV Study of Antibacterial Effect on Silver Dressing of NPWT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02274207
• Other study ID #: SS-14-NPWT
• Secondary ID: CGBIOW1404
• Status: Recruiting
• Phase: Phase 4
• First received: September 2, 2014
• Last updated: November 22, 2015
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: November 2015
• Source: Severance Hospital
• Contact: Woo Jin Choi, MD
• Phone: 82)2-2228-2195
• Email: choiwj[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• NPWT application
NPWT mode is cyclic mode : -125~-50 mmHg

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days to patient discharge	-Examine the days from applied medical device to discharge.	up to 4 weeks	No
Secondary	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))	No
Secondary	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	No
Secondary	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))	No
Secondary	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	No
Secondary	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))	No
Secondary	Days of NPWT application period	-Examine the period of NPWT application	up to 8 weeks	No
Secondary	Number of surgical debridement after NPWT	-Examine the number of debridement during applied NPWT	up to 8 weeks	No
Secondary	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	Yes
Secondary	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	Yes