Evidence Corner
Evidence Corner
Dear Readers: I would like to introduce a new column entitled Evidence Corner, written by AAWC members. Through this column, we hope to pique interest and provide perspective for new evidence supporting wound care protocols, procedures, and products. We hope you find Evidence Corner a valuable and informative tool as you strive for improved patient outcomes. This month we review a randomized trial of topically applied repifermin and a study of the cost effectiveness of venous and pressure ulcer protocols of care.
Laura Bolton, PhD
Column Editor
Robson MC, Phillips TJ, Falanga V, Odenheimer DJ, Parish LC, Jensen JL, Steed DL. Randomized trial of topically applied repifermin (recombinant human keratinocyte growth factor-2) to accelerate wound healing in venous ulcers. Wound Rep Reg 2001;9:347-52.
Rationale: Approximately 600,000 patients are affected by venous ulcers in the United States. While the cornerstone of care for venous ulcers is sustained graduated compression, other therapies include treatment of infection and edema and debridement. Accelerating wound healing could further improve the outcomes for venous ulcer patients. Repifermin, rhKGF-2, has been shown to accelerate healing in animal models. Its effects are explored here for venous ulcers.
Objective: Explore comparative safety and healing efficacy of topically applied repifermin versus placebo on venous ulcers.
Methods: A randomized, double-blind, parallel-group, placebo-controlled, 15-center study evaluated the safety and efficacy of topical 0 (placebo, n = 31), 20 (n = 31), or 60 (n = 32) µg/cm repifermin applied twice weekly in a liquid spray formulation for 12 weeks to venous ulcers also receiving compression therapy. Wound areas were measured using computer planimetry of wound tracings, and immunogenicity was measured as the titer of antibody species specific to repifermin produced by patients.
Results: The patient demographics and wound characteristics did not differ initially among the three treatment groups, which had mean ulcer durations from 11 to 14 weeks. Twelve-week healing rates were 29 percent for the placebo group, 32 percent for 20µg/cm rhKGF-2, and 38 percent for 60µg/cm rhKGF-2, respectively. For the subgroup of patients with wounds less than 15cm in area and less than 18 months in duration, significantly more venous ulcers reached 75-percent or 90-percent healing for the rhKGF-2 groups. Immunologic studies showed minimal response to repifermin.
Conclusions: Repifermin was concluded to be both safe and effective on venous ulcers.
Clinical Perspective: Larger rigorous studies of protocols using a human skin construct or a hydrocolloid dressing found more than 50 percent of average greater than 2-year-duration venous ulcers healed during 12 weeks of care. Healing efficacy reported for repifermin was not at a level reported in these earlier studies, though it appeared to be "well tolerated, with no differences in adverse events between repifermin-treated and placebo groups."
Kerstein MD, Gemmen E, van Rijswijk L, Lyder CH, Phillips T, Xakelli G, Golden K, Harrington C. Cost and cost effectiveness of venous and pressure ulcer protocols of care. Disease Management and Health Outcomes 2001;9(11):651-63.
Rationale: To meet the challenge of an aging population, providers and payers must optimize chronic wound care outcomes and contain costs.
Objective: To explore the costs, outcomes, and effects of outcomes on costs of protocols of wound care for pressure ulcers and venous ulcers.
Methods: This study used outcomes from a literature review to model the cost of 12 weeks of wound care for a hypothetical managed-care plan of 100,000 covered lives. Peer-validated wound care protocols were populated with meta-analytic averages of ulcer and treatment variables, such as ulcer size, dressing frequency per week, and percent healed. Only modalities with a pooled evidence base of greater than 100 wounds were used to populate the model. Costs excluded supportive treatments.
Results: Twenty-six studies of three pressure ulcer protocols of care (n = 519) and three venous ulcer protocols of care (n = 883) qualified for inclusion in the models. After 12 weeks of using these protocols of care, the weighted average proportion of ulcers healed was 51 percent with saline gauze, 48 percent with hydrocolloid dressing C, or 61 percent with hydrocolloid dressing D with corresponding costs per patient healed of $2179, $1267, or $910. Proportions of venous ulcers healed at 12 weeks using the corresponding protocols of care were 39 percent for impregnated gauze, 51 percent for hydrocolloid D, or 45 percent for a human skin construct with corresponding costs per venous ulcer patient healed of $2939, $1873, and $15063. Key drivers of costs of care were outcomes and frequency of dressing change. Gauze-based protocols cost more than protocols of care using hydrocolloid dressing D for both pressure and venous ulcers.
Conclusions: Despite the limitations of the models, "this analysis confirms that defining wound care costs solely as cost of products used is inaccurate and can be expensive."
Clinical Perspective: For a hypothetical managed-care organization with 100,000 covered lives, the annual difference between the least and most cost-effective care modalities was $1.9 million (US) for pressure ulcers and $5.8 million (US) for venous ulcers. Purchase price of the dressing applied was not an indication of cost effectiveness of a particular method of local wound care for either pressure ulcers or venous ulcers.
Dear Readers: I would like to introduce a new column entitled Evidence Corner, written by AAWC members. Through this column, we hope to pique interest and provide perspective for new evidence supporting wound care protocols, procedures, and products. We hope you find Evidence Corner a valuable and informative tool as you strive for improved patient outcomes. This month we review a randomized trial of topically applied repifermin and a study of the cost effectiveness of venous and pressure ulcer protocols of care.
Laura Bolton, PhD
Column Editor
Robson MC, Phillips TJ, Falanga V, Odenheimer DJ, Parish LC, Jensen JL, Steed DL. Randomized trial of topically applied repifermin (recombinant human keratinocyte growth factor-2) to accelerate wound healing in venous ulcers. Wound Rep Reg 2001;9:347-52.
Rationale: Approximately 600,000 patients are affected by venous ulcers in the United States. While the cornerstone of care for venous ulcers is sustained graduated compression, other therapies include treatment of infection and edema and debridement. Accelerating wound healing could further improve the outcomes for venous ulcer patients. Repifermin, rhKGF-2, has been shown to accelerate healing in animal models. Its effects are explored here for venous ulcers.
Objective: Explore comparative safety and healing efficacy of topically applied repifermin versus placebo on venous ulcers.
Methods: A randomized, double-blind, parallel-group, placebo-controlled, 15-center study evaluated the safety and efficacy of topical 0 (placebo, n = 31), 20 (n = 31), or 60 (n = 32) µg/cm repifermin applied twice weekly in a liquid spray formulation for 12 weeks to venous ulcers also receiving compression therapy. Wound areas were measured using computer planimetry of wound tracings, and immunogenicity was measured as the titer of antibody species specific to repifermin produced by patients.
Results: The patient demographics and wound characteristics did not differ initially among the three treatment groups, which had mean ulcer durations from 11 to 14 weeks. Twelve-week healing rates were 29 percent for the placebo group, 32 percent for 20µg/cm rhKGF-2, and 38 percent for 60µg/cm rhKGF-2, respectively. For the subgroup of patients with wounds less than 15cm in area and less than 18 months in duration, significantly more venous ulcers reached 75-percent or 90-percent healing for the rhKGF-2 groups. Immunologic studies showed minimal response to repifermin.
Conclusions: Repifermin was concluded to be both safe and effective on venous ulcers.
Clinical Perspective: Larger rigorous studies of protocols using a human skin construct or a hydrocolloid dressing found more than 50 percent of average greater than 2-year-duration venous ulcers healed during 12 weeks of care. Healing efficacy reported for repifermin was not at a level reported in these earlier studies, though it appeared to be "well tolerated, with no differences in adverse events between repifermin-treated and placebo groups."
Falanga V, et al. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Arch Dermatol 1998;134:293-300.
Lyons R, et al. Clinical benchmark for healing chronic venous ulcers. Am J Surg 1998;176(2):172-5.
Kerstein MD, Gemmen E, van Rijswijk L, Lyder CH, Phillips T, Xakelli G, Golden K, Harrington C. Cost and cost effectiveness of venous and pressure ulcer protocols of care. Disease Management and Health Outcomes 2001;9(11):651-63.
Rationale: To meet the challenge of an aging population, providers and payers must optimize chronic wound care outcomes and contain costs.
Objective: To explore the costs, outcomes, and effects of outcomes on costs of protocols of wound care for pressure ulcers and venous ulcers.
Methods: This study used outcomes from a literature review to model the cost of 12 weeks of wound care for a hypothetical managed-care plan of 100,000 covered lives. Peer-validated wound care protocols were populated with meta-analytic averages of ulcer and treatment variables, such as ulcer size, dressing frequency per week, and percent healed. Only modalities with a pooled evidence base of greater than 100 wounds were used to populate the model. Costs excluded supportive treatments.
Results: Twenty-six studies of three pressure ulcer protocols of care (n = 519) and three venous ulcer protocols of care (n = 883) qualified for inclusion in the models. After 12 weeks of using these protocols of care, the weighted average proportion of ulcers healed was 51 percent with saline gauze, 48 percent with hydrocolloid dressing C, or 61 percent with hydrocolloid dressing D with corresponding costs per patient healed of $2179, $1267, or $910. Proportions of venous ulcers healed at 12 weeks using the corresponding protocols of care were 39 percent for impregnated gauze, 51 percent for hydrocolloid D, or 45 percent for a human skin construct with corresponding costs per venous ulcer patient healed of $2939, $1873, and $15063. Key drivers of costs of care were outcomes and frequency of dressing change. Gauze-based protocols cost more than protocols of care using hydrocolloid dressing D for both pressure and venous ulcers.
Conclusions: Despite the limitations of the models, "this analysis confirms that defining wound care costs solely as cost of products used is inaccurate and can be expensive."
Clinical Perspective: For a hypothetical managed-care organization with 100,000 covered lives, the annual difference between the least and most cost-effective care modalities was $1.9 million (US) for pressure ulcers and $5.8 million (US) for venous ulcers. Purchase price of the dressing applied was not an indication of cost effectiveness of a particular method of local wound care for either pressure ulcers or venous ulcers.
