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

Phase 4

• Conditions: Diabetes Mellitus
• Interventions: Device: NPWT application

• Registration Number: NCT02274207
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Study Start: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-22
• Last Update Posted: 2015-11-24
• Primary Completion: 2016-05
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver dressing	NPWT application	Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea
non-silver dressing	NPWT application	Frequency and duration : 1 change/1day or according to statue of patient Dosage : 1 ea

Primary Outcome Measures

Name	Time	Method
Days to patient discharge	up to 4 weeks	-Examine the days from applied medical device to discharge.

Secondary Outcome Measures

Name	Time	Method
Number of surgical debridement after NPWT	up to 8 weeks	-Examine the number of debridement during applied NPWT
Rate of adverse event	up to 4 months (if adverse event appeared, Investigator follow until the disappearance of the symptom	-Examine adverse event every visit
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))	* Compare screening culture test with every visit culture test; * Examine days to infection clearance(point to show bacteria minus level in culture test)
Wound closure rate	up to 4 months	* Examine total wound closure rate in each groups.; * Wound closure: definition: skin graft, epithelized skin or simple suture et. al.
Lab - deviation of level	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
Days to complete wound closure	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
Days of NPWT application period	up to 8 weeks	-Examine the period of NPWT application
Elevation of wound evaluations grade	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.
Complete infection clear rate in wound culture results	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)

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of