Novel Wound Management for Venous Leg Ulcers
Novel Wound Management for Venous Leg Ulcers
Recent preliminary studies have shown Sepaderm® to be well tolerated and useful for the treatment of chronic, lower-extremity ulcerations, burn wounds, surgical excisions, chronic abdominal ulcers of hematoma origin, and chronic pressure ulcers. To confirm these initial findings, 18 cases of venous leg ulcers were treated with Sepaderm in conjunction with compression bandages. Patients had a mean age of 54.9 ± 13.5 years, and 78.9% were men. Six of the patients had previous standard treatments and 12 patients had Sepaderm as their initial treatment. Treatment duration with Sepaderm ranged from 6 to 90 days with a mean of 44.3 ± 25 days. The system was changed every 3 to 8 days depending on the amount of exudate. All the wounds responded positively with either partial or complete closure during treatment. Importantly, no patient experienced pain during the treatment. These findings suggest that Sepaderm may be effective for the treatment of venous leg ulcers.
Venous leg ulcers are chronic, recurrent, disabling, and affect up to 1 in 100 adults at some time, especially the elderly. In the United Sates, venous ulcers are estimated to incur treatment costs of approximately $3 billion per year, resulting in the loss of 2 million work days. Risk factors for chronic venous insufficiency include physical inactivity, being overweight, age, smoking, family history of venous disease, and prolonged standing time in women. Standard treatments for venous leg ulcers include simple dressings coupled with compression bandages or stockings, or using bilayer artificial skin substitutes in conjunction with compression bandages. However, despite treatment, venous leg ulcers sometimes remain open for months or years, and the recurrence rate is high, which negatively impacts patients' quality of life.
The initial feasibility and tolerability of using Sepaderm in 12 patients with chronic lower-extremity ulcerations and its successful treatment of single cases of five wound types including burn, surgical excision, a previously nonhealing venous leg ulcer, a chronic abdominal ulcer of hematoma origin, and a chronic pressure ulcer, has been reported recently. Sepaderm is a novel wound management system (Aalnex, Inc, Irvine, CA) with three components: an adhesive, fluid-resistant, circular-frame support cushion to be applied around the wound area; a flexible adhesive wicking strip to be placed along the wound edges to prevent leakage of exudate onto periwound skin and continuously transfer exudate to reservoir to prevent its build-up on the wound; and a reservoir that is applied onto the support cushion and wicking strip for the absorption, transfer, and sequestering of exudate away from the wound, which also protects the wound matrix from any disturbance. The reservoir is covered with a breathable, polyurethane membrane, which also functions as a bacterial barrier. Sepaderm requires less frequent changing, provides an adequate moist environment, absorbs large amounts of exudate, prevents leakage onto periwound skin, and does not adhere to or damage the healing tissues.
Eighteen patients were treated with Sepaderm to confirm its effectiveness in treating venous leg ulcers. The present study reports on the wound healing outcomes for these patients.
Abstract and Introduction
Abstract
Recent preliminary studies have shown Sepaderm® to be well tolerated and useful for the treatment of chronic, lower-extremity ulcerations, burn wounds, surgical excisions, chronic abdominal ulcers of hematoma origin, and chronic pressure ulcers. To confirm these initial findings, 18 cases of venous leg ulcers were treated with Sepaderm in conjunction with compression bandages. Patients had a mean age of 54.9 ± 13.5 years, and 78.9% were men. Six of the patients had previous standard treatments and 12 patients had Sepaderm as their initial treatment. Treatment duration with Sepaderm ranged from 6 to 90 days with a mean of 44.3 ± 25 days. The system was changed every 3 to 8 days depending on the amount of exudate. All the wounds responded positively with either partial or complete closure during treatment. Importantly, no patient experienced pain during the treatment. These findings suggest that Sepaderm may be effective for the treatment of venous leg ulcers.
Introduction
Venous leg ulcers are chronic, recurrent, disabling, and affect up to 1 in 100 adults at some time, especially the elderly. In the United Sates, venous ulcers are estimated to incur treatment costs of approximately $3 billion per year, resulting in the loss of 2 million work days. Risk factors for chronic venous insufficiency include physical inactivity, being overweight, age, smoking, family history of venous disease, and prolonged standing time in women. Standard treatments for venous leg ulcers include simple dressings coupled with compression bandages or stockings, or using bilayer artificial skin substitutes in conjunction with compression bandages. However, despite treatment, venous leg ulcers sometimes remain open for months or years, and the recurrence rate is high, which negatively impacts patients' quality of life.
The initial feasibility and tolerability of using Sepaderm in 12 patients with chronic lower-extremity ulcerations and its successful treatment of single cases of five wound types including burn, surgical excision, a previously nonhealing venous leg ulcer, a chronic abdominal ulcer of hematoma origin, and a chronic pressure ulcer, has been reported recently. Sepaderm is a novel wound management system (Aalnex, Inc, Irvine, CA) with three components: an adhesive, fluid-resistant, circular-frame support cushion to be applied around the wound area; a flexible adhesive wicking strip to be placed along the wound edges to prevent leakage of exudate onto periwound skin and continuously transfer exudate to reservoir to prevent its build-up on the wound; and a reservoir that is applied onto the support cushion and wicking strip for the absorption, transfer, and sequestering of exudate away from the wound, which also protects the wound matrix from any disturbance. The reservoir is covered with a breathable, polyurethane membrane, which also functions as a bacterial barrier. Sepaderm requires less frequent changing, provides an adequate moist environment, absorbs large amounts of exudate, prevents leakage onto periwound skin, and does not adhere to or damage the healing tissues.
Eighteen patients were treated with Sepaderm to confirm its effectiveness in treating venous leg ulcers. The present study reports on the wound healing outcomes for these patients.
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