Wound Fluid Protease Levels During Use of Novel Wound Dressing

Hollister Incorporated35 enrolled

Overview

This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.

Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Venous Stasis Ulcers

Interventions

Novel DressingDEVICE

Topical wound dressing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of venous insufficiency * One or more partial or full-thickness venous leg ulcers 5-24 sq. cm in size without evidence of clinical infection * Ankle/brachial index 0.8 and above * Duration of wound up to one year * Able to return to wound clinic for weekly evaluations * Has signed Institutional Review Board approved informed consent Exclusion Criteria: * Exposed bone or tendon or necrotic wound base * Signs or symptoms of cellulitis or osteomyelitis at the target ulcer * Allergy to a component of the novel dressing or compression wrap * Third degree burn * Vasculitis, severe rheumatoid arthritis or other collagen vascular disease * Receiving antibiotics * Pregnant or lactating

Locations (8)

Arizona Heart Hospital

Phoenix, Arizona, United States

Phoenix Baptist Hospital

Phoenix, Arizona, United States

University of Miami, Department of Surgery, Div. of Vascular Surgery

Miami, Florida, United States

Alexian Brothers Medical Center Wound Healing Center

Outcomes

Primary Outcomes

Matrix Metalloproteinase Level in Wound Fluid

Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups.

Time frame: 8 weeks

Secondary Outcomes

Wound Healing

change in wound area mean was calculated for each subject Mean and sd were calculated for each group

Time frame: 12 weeks

Data from ClinicalTrials.gov

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