Clinical Trials within U.S.: Skin Transplants (Burns)

THE SKIN IS a vital organ for maintaining body homeostasis, and is a major immunologie defense against infection. When the integrity of the skin is [Page 129]compromised, such as in severe burn injuries, the person is at risk for complications such as dehydration as well as infection. Therefore, a skin transplant is often performed by splitting skin from a less damaged region of the body to another, more damaged region. The process of skin transplantation, particularly after a burn, is still undergoing improvement, and the way to test novel techniques is via a clinical trial.

A clinical trial is a critical method for determined the safety, efficacy, and benefit of a potential new clinical technique. This technique may be for treatment, therapy, diagnostic purposes, prevention, or improvement of the patient's quality of life. Although based on promising laboratory research, clinical trials are not guaranteed to work and must be understood as trials. For example, the volunteers for clinical trials of a novel therapy are not guaranteed an improvement in their condition and in fact are taking a significant risk. Nevertheless, while these volunteers may not see improvement themselves, they are doing a great service to others with the disease, as clinicians will learn about therapeutics and the potential benefits or harms of a particular technique.

According to the U.S. National Institutes of Health, there are two major classes of clinical trials. These classes are interventional, which measure a treatment type, and observational, where the clinicians monitor a particular patient group. A clinical trial involving a skin transplant, particularly in the treatment of a burn, would be an interventional clinical trial.

Clinical trials that have been completed in the United States include trials examining the optimal method of affixing the transplant to the new location. Options included skin staples, stitches, or medical adhesive such as cyanoacrylate glue. Severely damaged skin especially after a burn injury, is fragile and can be difficult to work with using tools such as sutures or staples, and some studies showed a benefit to using a medical adhesive.

Other trials investigate the use of certain topical healing agents such as anti—inflammatory creams or ointments, or anti—scarring treatments. One study examined the use of cultured skin substitute over using split skin from a less—affected body area. Cultured skin substitute (CSS) is a biopolymer generated in the laboratory that contains an artificial matrix onto which human cells are encouraged to grow using growth factors to induce the differentiation of skin cells. Another type of cultured skin transplant is a cultured epidermal autograft (CEA), which is a cultured skin from the patient's own cells. CEAs do no necessarily have a matrix.

U.S. Air Force surgeons perform a procedure involving skin grafting at Bagram medical facilities in Afghanistan.

Given the nature of the skin excision and graft process, bleeding can be a devastating issue. In order to prevent severe bleeding during and after the procedure, clinical trials have investigated the utility of anti—bleeding factors when used in the adhesives for the graft. A recent study presented at the 2008 American Burn Association meeting showed that a novel product called Recothrom, a recombinant form of Thrombin, made by the [Page 130]company ZymoGenetics, can be used effectively to seal the borders of a skin transplant on a burn patient. This product is a spray and therefore easy to administer. The study was carried out at the University of California, Davis Medical Center and led by Dr. David G. Greenhalgh. Thrombin is physiologically considered a coagulation factor, involved in the cessation of blood flow. An earlier study, in which Greenhalgh also participated, showed that fibrin, a blood clotting factor, was also effective as a spray—on treatment to prevent bleeding.

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