Apligraf® in Practice – Dr. Serena
Case presented by Thomas E. Serena, MD, Director, Penn North Center for Advanced Wound Care, Warren, Pennsylvania.
Patient: J.A.*
Wound: Large, Recurrent Venous Leg Ulcers†
Age: 57 years old
Sex: Female
Duration of the condition: 20 years
*Not the patient’s real initials.
†The case presented here represents the experience of a single patient and may not be typical of all patients.
History
Figure 1:
Preapplication.
J.A. is a 57-year-old woman troubled with recurrent venous leg ulcers for the past 20 years. The ulcers in question – 2 large venous stasis ulcers on her right leg—appeared in 1995. Prior treatments have included inelastic compression therapy (Unna’s boot), saline dressings, antibiotics, and vein stripping. However, after 3 years of treatment, the ulcers persisted.
Evaluation
Figure 2:
Week 0 - Apligraf is perforated to allow passage of exudate.
J.A. presented in November, 1998, with 2 large ulcers on her lower right leg. The pain from these ulcers was so severe that on a scale of 1 to 10, she graded it a 10. The pain made it increasingly difficult for her to work as a waitress, even with the aid of narcotic analgesics.
Treatment
Figure 3:
Week 2 - Granulation tissue is evident.
Upon examination, the patient had a medial ulcer measuring 11 x 3 cm (Figure 1) and a lateral ulcer measuring 3 x 2 cm on her right leg. The patient was initially treated with saline dressings and platelet-derived growth factor to promote granulation, along with inelastic compression therapy (Unna's boot), for 3 months prior to Apligraf application. On February 4, 1999, we applied Apligraf to each of the ulcers. The application took place in the operating room without anesthesia. Each graft was "pie crusted" (fenestrated) to allow for drainage (Figure 2) and held in place with a nonocclusive dressing (Xeroform®), Kerlix® gauze, and Ace™ wraps. The dressings were changed every 3 to 5 days.
Clinical Observations
Figure 4:
Week 12 - Marked reduction in wound area.
The smaller, lateral ulcer healed in 1 week. The larger, medial ulcer healed steadily. While waiting for complete healing of the medial ulcer, we treated the patient with additional inelastic compression therapy.
- By week 2 (Figure 3), granulation tissue is evident. The wound has a yellowish white, gelatinous appearance. The appearance may be normal unless clinical signs of infection are present*.
- By week 12 (Figure 4), there is a marked reduction in the size of the wound area. Epithelization and new tissue formation are evident.
- By week 20 (Figure 5), complete closure and remodeling are apparent, accompanied by decreased periphery pigmentation.
Discussion
Figure 5: Week 20 - Complete closure.
Apligraf resulted in the closing of 2 large wounds that had persisted for 3 years. In addition, the patient reported a significant reduction in pain within the first month of therapy and no longer required narcotic analgesics. She is now pain free and has been able to return to work and resume all other normal daily activities. Apligraf is indicated for use along with standard compression therapy in venous ulcers of at least 1 month’s duration that have not adequately responded to conventional ulcer therapy. Apligraf should not be used on infected wounds or on patients with known hypersensitivities to any components of Apligraf or the shipping medium. Please consult the complete prescribing information for a description of epidermal and dermal elements contained in Apligraf.
*Unless there are clinical signs of infection (pain, swelling, heat, redness, purulent discharge), the wound should be left alone, rebandaged, and reassessed at the next follow-up visit.
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