Wound Fluid Protease Levels During Use of Novel Wound Dressing

Hollister

Status and phase: Completed; Phase 4

Conditions: Venous Stasis Ulcers

Treatments: Device: Novel Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01567150

5064-W

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

novel dressing

Active Comparator group

Description:

Treatment with novel dressing

Treatment:

Device: Novel Dressing

Control

No Intervention group

Description:

Control is treatment without novel dressing