Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01214811
Other study ID # MxB Ag 01
Secondary ID
Status Completed
Phase Phase 3
First received October 4, 2010
Last updated February 28, 2013
Start date September 2010
Est. completion date December 2011

Study information

Verified date December 2011
Source Molnlycke Health Care AB
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need* of topical antimicrobial treatment according to the physician.


Description:

The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator

- Male or female, 18 years and above, both in- and out-patients

- Signed Informed Consent Form

Exclusion Criteria:

- Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation

- Subject not expected to follow the investigation procedures

- TBSA > 10% (partial thickness burns only)

- HbA1C value > 7.2. (To be measured if BMI > 30)

- Pregnant and breastfeeding women

- Pressure ulcers deeper than stage 3

- Deep pressure ulcers in need of a filler

- Subjects with known sensitivity to silver or any other dressing materials

- Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging

- Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide

- Subjects previously included in this investigation

- Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Mepilex Border Ag
Mepilex Border Ag may be left in place for up to seven days, depending on the condition.

Locations

Country Name City State
United States Center for Curative & Palliative Care, Calvary Hospital Bronx New York
United States Burn treatment center Iowa city Iowa
United States Institute for advanced wound care Momtgomery Alabama

Sponsors (1)

Lead Sponsor Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound Are at Baseline Baseline No
Primary Wound Area at Visit 2 At each visit the wound length and width is measured and calculated in cm2. After one week No
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT05910489 - Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect