Skin Substitute Effective in Closing Large Wounds in Children

November 03, 2003

Alicia Ault

Nov. 3, 2003 (New Orleans) — The skin substitute Apligraf is effective in closing wounds due to infection, burns, and trauma, potentially negating the need for donor grafts, researchers reported here Saturday at the American Academy of Pediatrics National Conference and Exhibition.

Lead author Frank Vicari, MD, from the Children's Memorial Hospital in Chicago, Illinois, presented 20 case studies; all of the patients were treated with Apligraf in the acute setting. Eight patients had surgical wounds, four needed reconstruction, six had wounds due to trauma, and two were burn patients.

Apligraf is a two-layer skin substitute cultured from human foreskin cells and grown on a bovine collagen matrix. The product's epidermal layer is made up of human keratinocyte cells and the dermal layer contains human fibroblast cells. It does not contain Langerhans' cells, melanocytes, macrophages, lymphocytes, white blood cells, blood vessels, hair follicles, or sweat glands, according to its maker, Organogenesis, based in Canton, Massachusetts. Apligraf is approved by the U.S. Food and Drug Administration for the treatment of venous leg ulcers and diabetic foot ulcers, but not for pediatric use.

Dr. Vicari told Medscape in an interview that he decided to start using Apligraf in children when one patient, a 12-year-old girl, with dry gangrene leading to necrotic toes on one foot, was being prepped for below-knee amputation. He decided to try Apligraf instead; the girl required debridement and two applications. After a year, she lost the toes but was ambulatory.

In the case series, Apligraf was successfully used to close wounds in all 20 patients, including one child who had significant open wounds from necrotizing fascitis covering 20% of his body surface, Dr. Vicari told the meeting attendees. Three patients required reapplication of the skin substitute to fully close wounds, but no complications were observed.

For many of the children, the skin substitute, which was usually applied at bedside without general anesthesia, was a life-saver, Dr. Vicari said. "Some of these kids I couldn't take to the operating room — they would have died," he told Medscape. Other children were unsuitable candidates for harvesting split-thickness grafts because of wound size and other factors, he said.

Arlen Dwight Denny, MD, FAAP, from the Medical College of Wisconsin in Milwaukee, told Medscape that Dr. Vicari's study "looks important." Although he does not usually see trauma or burn patients, he does treat children with spina bifida in whom he might use Apligraf. "It would be nice to have one more option," he said.

Dr. Vicari told Medscape he has used Apligraf in 40 patients now and hopes to publish his reports. He did not receive funding from Organogenesis, but he is a member of the Novartis Advisory Board. Novartis previously owned worldwide rights to Apligraf, but Organogenesis reacquired those rights when it emerged from bankruptcy in September.

AAP 2003 National Conference and Exhibition: Abstract 668. Presented Nov. 1, 2003.

Reviewed by Gary D. Vogin, MD

Alicia Ault is a freelance writer for Medscape.


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