Skin securement has always been an essential final step in surgical procedures. Historically, the skin surface was sutured; in recent years a number of advances have been made, including new tapes, sutures, staples, hemostats, and glues. High strength glues, in particular, find some of their biggest potential in dermal applications, given the problems of, for example, cyanoacrylate toxicity for internal applications.
The applications for skin securement are categorized by burns, ulcers (pressure, venous) and plastic surgery. While the most acute need is in the area of burn treatment, the vast majority of procedures in skin securement are comprised of ulcers and plastic surgery.
Pressure ulcers develop in immobile patients who often suffer from underlying biochemical deficiencies that lead to inadequate skin healing. Prevalence is highest in the old and infirm, and incidence is increasing in line with aging of the population. Sealants, hemostats, and closure products provide opportunities for a radical surgical method to treat these life-threatening wounds, which normally would be treated with conservative (though often sophisticated) wound healing products designed to reduce points of pressure, mask smell and absorb excess moisture while the body repairs itself. The strongest opportunity for use of surgically oriented products for repair of pressure ulcers is among young paraplegics and short-term acute care patients who are immobilized but otherwise healthy (approximately 5% of all pressure ulcers).
In diabetic ulcers, diabetes causes many abnormalities in tissue biochemistry and nutrition, many of which lead to impaired tissue healing. In addition, diabetes leads to conditions of hypoxia and peripheral neuropathy that can directly cause ulcers. Approximately 800,000 diabetics in the United States have diabetic foot ulcers; closure and securement products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.
There are approximately one million venous ulcer patients in the United States today. Prevalence is increasing in line with aging demographics exacerbated by a sedentary lifestyle. Venous ulcers are caused by underlying vascular and venous flow abnormalities, which can often be treated by knowledgeable application of pressure bandaging and, in some cases, appropriate topical wound care. However, this treatment is largely symptomatic and many physicians believe surgical intervention to repair the underlying vascular abnormalities is required to effect a cure and avoid tissue breakdown. Sealants, hemostats, and closure products offer a surgical route to aiding repair that may offer potential to accelerate repair in a number cases.
About 2 million plastic surgery (cosmetic) procedures are performed in the United States every year. The most popular procedures are liposuction (455,000) and breast augmentation (365,000). Most of the latter use synthetic materials and biomaterials for augmentation purposes. Other procedures where sealant products may be relevant include rhinoplasty (200,000), abdominoplasty (170,000) and eyelid surgery (230,000).
Adjunctive products for securement and closure offer potential to improve surgical procedure, reduce infections, and improve aesthetic and physiological properties of newly repaired tissues, as well as offering more rapid rehabilitation and the avoidance of donor site morbidity in approximately 27,000 of these operations involving the use of donated tissue from another region of the patient’s body.
See report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure Market."