Clinical Experience Using a Novel Wound Management System for Venous Leg Ulcers

Index: WOUNDS 2012;24(3):47–50.

  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.¹ In the United States, venous ulcers are estimated to incur treatment costs of approximately $3 billion per year, resulting in the loss of 2 million work days.² Risk factors for chronic venous insufficiency include physical inactivity, being overweight, age, smoking, family history of venous disease, and prolonged standing time in women.³ 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.¹ However, despite treatment, venous leg ulcers sometimes remain open for months or years and the recurrence rate is high,¹ which negatively impacts patients’ quality of life.⁴   The initial feasibility and tolerability of using Sepaderm in 12 patients with chronic lower-extremity ulcerations⁵ and its successful treatment of single cases of five wound types including burn,⁶ surgical excision,⁶ a previously nonhealing venous leg ulcer,⁶ a chronic abdominal ulcer of hematoma origin,⁷ and a chronic pressure ulcer,⁸ 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.^5,6   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.

Methods

  Eighteen patients who sought treatment of their venous leg ulcers at the Wound Treatment Center of the Opelousas General Hospital were treated with Sepaderm in conjunction with compression bandaging without any inclusion or exclusion criteria. Wound appearance, conditions, dimensions, and patient pain were recorded during clinical visits. Granulation was assessed using a 5-point scale (1 = none, 2 = < 25%, 3 = 25%–50%, 4 = 51%–75%, 5 = 76%–100%). Pain was assessed using a visual analog scale of 0–10 (0 = no pain and 10 = most pain). Other clinical parameters, such as amount of exudate, periwound condition, and odor were recorded. In some cases, after the investigator had determined that the wounds had reduced in size by 90% or more, the patients were switched to standard dressings to lower costs.

Results

  Patients were predominantly men (77.8%), black (66.7%), and with a mean age of 54.9 ± 13.5 years (range, 34 to 77 years). Six patients had been previously treated with standard treatments and 12 patients received Sepaderm as their initial treatment. All of the wounds responded positively to the Sepaderm treatment. Figure 1 shows results at weeks 1 and 4 for a venous leg ulcer that previously showed modest response to standard treatment. Ten of 16 patients who were treated for 3 to 13 weeks had either > 80% healing or complete wound closure. Two patients had the shortest treatment duration of 1 week with wound closure of 15% and 33%, respectively. The average healing rate of all 18 patients is shown in Figure 2. The treatment resulted in very good initial healing rates during the first 4 weeks among these patients (Table 1). Importantly, patients experienced no pain in the wound area throughout the treatment duration (Table 2). The wounds were well granulated during treatment (Table 2). The amount of exudate was small to moderate and there was no foul odor. There was no maceration of periwound skin with Sepaderm treatment, except for one patient who had maceration at baseline and whose periwound skin returned to normal after 6 days of treatment. The design of Sepaderm’s circular-frame support cushion, in combination with the wicking strip and reservoir, prevented exudate built-up on the wound and protected the wound matrix from disturbances.

Discussion

  Standard treatments for venous leg ulcers using simple dressings and compression bandages have limitations, such as poor healing rates and ulcers that can remain open for months or even years. Bilayer artificial skin grafts offer an advantage over simple dressings in improving healing rates, as well as wound closure.¹ More recent wound dressings, such as collagen/oxidized regenerated cellulose dressing, negative pressure dressing, biological extracellular matrices, and silver alginate wound dressings, have been introduced with mixed results.^9–11 In spite of these available treatments, some venous leg ulcers still do not heal, resulting in poor quality of life for patients⁴ and a burden on the healthcare system. Even when ulcers heal, recurrence rates are rather high.^1,12 Thus, a medical need exist for new wound management systems that are cost effective and improve venous leg ulcer healing.   Recently, Sepaderm was reported to be well tolerated and had shown positive response in a preliminary study of chronic, lower-extremity ulcerations.⁵ The authors have also reported on the successful treatment of single cases of three wound types, a burn, a surgical excision, and a chronic venous leg ulcer that did not heal, even with repeated Apligraf® (Organogenesis, Inc, Canton, MA) applications.⁶ All three wounds healed completely with normal periwound tissue.⁶ Additionally, this system completely healed a chronic abdominal ulcer of hematoma origin¹⁰ and a chronic pressure ulcer that previously failed to heal under standard treatments including silver, collagen, and negative pressure wound therapy.¹¹   To confirm the preliminary clinical effects, 18 patients who sought treatment for their venous leg ulcers at the Wound Treatment Center were treated with Sepaderm. Upon treatment, all patients had various degrees of healing, including complete wound closure with a mean healing rate of 0.31 cm ± 0.05 cm/week for the initial 4 weeks of treatment. These healing rates exceeded the 0.11 cm/week initial healing rate that predicts complete wound closure for venous leg ulcers at 24 weeks.¹³ The Sepaderm system stayed in place for the duration between dressing changes and there was no exudate leakage. The majority of patients had normal periwound tissues during treatment and Sepaderm did not induce maceration. Importantly, no patient experienced pain in the wound area during the course of treatment, and this can have a positive impact on the quality of life compared to standard treatments. Patients and clinicians were satisfied with the system due to less frequent dressing change, increased healing rate, comfortable wear, good compliance, and ease of use. Fewer dressing changes (3 to 8 days) compared to standard dressings, lack of pain, lack of exudate leakage, and the improved healing rates can lead to fewer clinic visits and the reduction of the overall cost of treatment. In spite of the positive outcome, this study lacks a parallel control group, and thus, direct comparisons cannot be made between wound healing with Sepaderm and a standard treatment. However, it should be noted that six venous leg ulcers that previously showed minimal responses to standard treatment had positive responses to Sepaderm.

Conclusion

  The treatment of venous leg ulcers with Sepaderm was well accepted by both patients and clinicians. Treatment for various durations resulted in partial to complete wound closure in 18 patients with or without previous standard treatments. None of the patients experienced wound pain with the use of Sepaderm. Further studies are needed to confirm the advantage of Sepaderm over standard venous leg ulcer treatments.

Acknowledgement

  Dr. Tam is a paid consultant for Aalnex, Inc.

References

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