Wounds are clinically classified by examining their depth and associated damage (partial, deep partial, full thickness, or underlying tissue damage), as well as their etiology or cause (surgical, traumatic, burns, chronic, or carcinoma). These parameters influence the selection of wound treatment, and the potential usefulness of new technologies and adjunctive surgical closure and securement products.
Factors Affecting Wound Healing
- Mechanical stress
- Desiccation and maceration
- Chemical stress
- Other factors such as alcohol abuse, smoking, and radiation therapy
Source: MedMarket Diligence, LLC; Report #S190, “Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017” and Report #S249, “Wound Management, Worldwide Market and Forecast to 2021: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”
In managing chronic and acute wounds, fibrin and synthetic sealants offer a significant advantage over pure hemostats because they do not rely on the full complement of blood factors to produce hemostasis. Sealants provide all the components necessary to prevent bleeding and will often prevent bleeding from tissues where blood flow is under pressure and the damage is extensive. In addition to hemostats and sealants, a number of companies have developed tissue glues to reduce (and in some cases replace) the requirement for sutures. These products are capable of providing a degree of repair strength that is at least an order of magnitude greater than that achieved with fibrin and synthetic sealants. These products have the potential to replace sutures in some cases where speed and strength of securement are priorities for the surgical procedure. Tapes, sutures and staples are also applicable to a growing range of procedure-specific internal securement cases.
Selected applications of fibrin and other sealants:
- Local hemostatic measures for both surgical and trauma cases
- Surgery in patients with bleeding disorders (e.g., hemophilia, severe thrombocytopenia) and non-bleeding cases with suspected fluid oozing
- Surgery in nonsuturable organs (e.g., brain, liver, lung, pancreas, thymus) or to repair unhealthy tissue (e.g., irradiated bowel or tissue of elderly patients)
- Cardiovascular, microvascular surgery and vascular grafts (e.g., aneurysm repair, coronary bypass, etc.)
- Nerve grafts
- Skin grafts, particularly plastic surgery
- Surgery of small or difficult to reach organs (e.g., tympanoplasty, ENT, eye)
- Sealing of body cavities, fistulae, pneumothorax, cranium, etc.
- Anastomosis of gastrointestinal, tract and other ductal organs
While fibrin and other sealants are deeply penetrating caseload in closure of many acute wound types, their success is constrained by the strength of the adhesion they produce. Sutures (and their descendants, like staples/clips) provide a level of closure that sealants and glues cannot (for the time being) challenge for many wound types.
Ultimately, a significant share of many acute wounds (and certainly all of some types) will be closed through the use of high-strength glues.
High-strength glue products were approved for topical closure applications in the United States in the late 1990s, but have been used considerably more outside the USA. In other countries, such as the major markets of the EU, high-strength glues and adhesives were approved several years ago and have built up a track record of use in internal surgery. Today, high-strength glues are being used in a wider range of procedures both in the US and outside the US. Physicians and researchers are exploring how these glues may be utilized in current or new procedures to produce more cost-effective, better outcomes with reduced morbidity and mortality. The unmet need for non-toxic, high-strength, resorbable glues is clearly demonstrated by adoption of existing glue products outside of the United States. These products have high-strength sealant and adhesive properties that are driving their increasing adoption by clinical practitioners, starting with surgical closure and specific internal procedures for which there is no good alternative. MedMarket Diligence is also seeing increasing usage for tissue adhesives in vascular, neurological, spinal, orthopedic, and other procedures.
For further details on the products, clinical applications, companies and markets in wound closure, see “Surgical Sealants, Glues, Wound Closure and Anti-Adhesion, Worldwide Markets, 2012-2017” (report #S190), from MedMarket Diligence, LLC.