Using Becaplermin Gel with Collagen Products to Potentiate Healing in Chronic Leg Wounds
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Disclosures: This study was unsupported and unsolicited. Dr. Carson is an occasional speaker for Healthpoint, Ltd., Fort Worth, Texas. This work was presented at The Wound Healing Society’s 13th Annual Educational Symposium and Exhibition, May 5, 2003, Seattle, Washington.
Becaplermin gel (Regranex®, Johnson & Johnson Wound Management, Somerville, New Jersey) a genetically engineered, platelet-derived growth factor (PDGF) that mimics human PDGF, has been approved for use in diabetic lower-extremity ulcers since 1997. Becaplermin also appears to be effective in nondiabetic patients with chronic wounds, and it is frequently used in these patients.[2–4] Becaplermin gel’s effect on chronic wounds is often less than stunning, often taking months to show a progression to healing in many series. The cost for a 15-ounce tube varies from $350.00 to $500.00 in the authors’ area (Southern California).
Early in the use of becaplermin gel on chronic wounds of the legs, the authors were thwarted by the original instructions to change the dressing every 12 hours. In this outpatient setting, many patients were unable or unwilling to cooperate with this plan. As a result, the authors noted that many wounds would dry out or become contaminated before the next visit. Consequently, the authors began to try alternate methods for application of becaplermin. The original concept in the authors’ use of collagen with becaplermin was to provide a longer-lasting, moist dressing that would protect the becaplermin gel and the wound. Extraneous collagen often derived from bovine or swine sources has been used for decades as an adjunct for wound healing. Exact mechanisms of collagen’s assistance in wound healing remain to be precisely defined, but its useful effects are well known. The authors felt that collagen might also potentiate the duration of effect of becaplermin by providing a slower release of becaplermin and by slowing the destruction of the becaplermin.
All formulations of collagen did not appear equally effective when used in this manner, and the authors chose to use two collagen products with becaplermin gel based on preliminary trial and error. These preparations were Fibracol Plus® (collagen-alginate, Johnson & Johnson Wound Management, Somerville, New Jersey) and Oasis® (small intestinal submucosa [SIS], Healthpoint, Ltd., Fort Worth, Texas). The collagen-alginate product is a combination of 10-percent alginate and 90-percent collagen, and SIS is derived from submucosa of porcine small intestine.[6,7] As this treatment appeared efficacious in diabetic patients, the authors expanded the treatment to include nondiabetic patients as well. This was done with the provision that the patients had not responded to collagen or becaplermin gel alone and had other known factors that interfered with wound healing (e.g., ischemia, poor nutrition, pressure, and infection) corrected as much as possible.
All of the patients had wound care involving maintenance debridement and moist dressings and failed to show signs of healing. In some instances, ultrasound, electrical stimulation, hyperbaric oxygen, and vacuum-assisted closure had also been used without a significant healing response. Criteria of a significant healing response were decrease in wound size, proliferation of granulation tissue, absence of heavy or foul discharge, and absence of progressive or recurring necrosis.
Materials and Methods
Thirty-six consecutive patients over a three-year period with wounds that failed to heal by other wound care techniques were treated simultaneously with becaplermin gel and a collagen product (18 collagen-alginate and 18 SIS). Initially, patients were treated with collagen-alginate, but as its availability diminished, SIS was used as it became more readily available. All patients gave informed consent for their specific procedures and their treatments.
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