Coordination and integration of surgical skills and products in the operating room, along with evidence-based decision making and patient-centered interventions, form the hallmark of optimal surgical care. Tissue grafts, wound dressings, and scaffolds all work together in the complex situations faced by surgeons and their teams. These factors present a unique challenge in modern surgical practice. Advanced biologic allografts have a distinct role to play in a holistic surgical plan.
Biologic allografts are processed human tissues intended for implantation. The use case and clinical scenario guide the placement of biologic allografts in various specialty surgeries. Allografts do not serve as generic remedies in contemporary practice. Instead, surgeons consider anatomy, wound healing, tissue quality, surgical goals, patient risk factors, and practitioner preference when selecting a biologic allograft.
Sanara MedTech specializes in the design and market readiness of advanced surgical, tissue repair, and wound care products. Sanara offers tissue allografts and other technologies, including TEXAGEN®, ALLOCYTE® Plus, ACTIGEN™, CellerateRX®, FORTIFY®, and BIASURGE® Advanced Surgical Solution. Based on its product descriptions, Sanara has developed multilayer composite amniotic membranes for soft tissue and wound coverage with the TEXAGEN® product line. ALLOCYTE® Plus is a cellular bone allograft that contains viable bone-forming cells and a DMSO-free cryoprotectant.
The Use of Biological Allografts as Substitutes in Surgery
Biological allografts provide supplemental support when the body needs structural, cellular, or tissue-based elements. Depending on the product, an allograft can act as a temporary barrier or wound covering. It can also fill soft tissue or bone voids, provide a supportive matrix or scaffold, or help promote the growth of new, functioning tissue.
In general, allografts assist surgical teams in achieving surgical objectives such as:
● Covering or protecting a surface of exposed tissue
● Supporting the repair of soft tissue
● Filling a void that is present in bone tissue
● Providing a biologic scaffold
● Supporting the process of structuring a wound
The specific product and its Instructions for Use determine the extent of its role. Therefore, surgeons should evaluate each allograft based on its intended use rather than assuming that all biologic products are equivalent.
Integration Into Standardized Surgical Protocols
One reason advanced biologic allografts work well with contemporary surgical protocols is that surgical teams can assign them to specific steps in the surgical protocol.
A surgical protocol can describe:
● Whether the allograft should be considered at this point in the surgery
● The type of wound or defect for which the allograft is appropriate
● How the team needs to store it
● How the team should open and prepare it
● Who should handle it in the sterile field
● How the team should place or secure it
● What the team should document about how the product was used
● What the postoperative care should include
A protocol with these features helps reduce ambiguity for the surgical team when using the allograft. It also enables a facility to establish a consistent way to document and review allografts in the future.
However, consistency in the use of protocols should never replace clinical judgment. Surgeons must assess individual patients and determine if a particular product is appropriate for use.
Tissue Safety, Donor Screening, and Regulatory Concerns
The use of tissue biologic allografts creates certain challenges for surgical protocols related to safety and traceability. Healthcare personnel must understand potential safety issues related to the donor, tissue processing, tissue storage, storage time, and tissue tracking.
As described by the FDA, regulations under 21 CFR Part 1271, Subpart C, specify requirements for determining donor eligibility, donor screening and testing, and other issues related to the use of human cells, tissues, and cellular and tissue-based products. The FDA states that, with certain exceptions, HCT/P donors must undergo testing for relevant communicable disease agents or diseases when no FDA-approved, FDA-cleared, or FDA-licensed donor screening tests exist.
Therefore, healthcare teams must manage biologic allografts differently from most other surgical supplies. The focus should remain on clear and systematic procedures for storage, preparation, documentation, and traceability. Use should also follow the current Instructions for Use (IFU) of the manufacturer, facility policy, and regulatory requirements.
Sanara has stated that its team processes and handles TEXAGEN® in accordance with FDA and AATB standards. The Association for Advancing Tissue and Biologics has stated that its Standards for Tissue Banking provide a recognized standard for tissue banking.
Amniotic Membrane Allografts and Their Place in Protocols
Amniotic membrane allografts are biologic wound coverings and soft tissue barriers. Surgical teams evaluate them based on product qualities such as handling, thickness, ease of hydration, and tissue form. They also consider the allograft’s intended use.
Amniotic membranes are multilayer tissues. Sanara implies that its TEXAGEN® product is a multilayer amniotic membrane that can serve as a soft tissue barrier and wound covering in various circumstances. Sanara’s TEXAGEN® states that its tissue preserves the extracellular and intracellular matrix components, along with the amniotic growth factors and cytokines. TEXAGEN® does not require preparation before use. It hydrates quickly at the surgical site, can remain at ambient temperature, and has a 5-year shelf life.
From a protocol perspective, these handling features can help surgical teams manage their workflow when placing and hydrating the graft at the surgical site. They can also help teams document graft placement at the surgical site.
Viable Bone Allografts and Their Place in Protocols
If the surgery deals with bones, the biologic allograft must meet different criteria. If the surgeon needs to support the bone-forming environment or fill a bone void, product selection will focus on osteoconduction, osteoinduction, and cellular aspects of the product. Handling and storage also remain important.
Sanara claims that ALLOCYTE® Plus Advanced Viable Bone Matrix is a next-generation cellular bone allograft. The product consists of viable progenitor cells and a DMSO-free cryopreservation medium. Viable bone matrices can serve surgical needs because they contain a scaffold and live cells and may promote healing.
However, viable bone grafts have specific requirements for frozen storage. They also require precise timing for thawing and graft placement. Surgical teams should assign these steps to a consistent workflow in the Operating Room. This approach helps ensure that shaving, opening, graft transfer, and the surgery itself remain coordinated.
The Integrated Allograft Structure Does Not Eliminate Complex Healing
While sophisticated bone graft alternatives may seem to ensure better healing outcomes, many factors contribute to the body’s ability to heal. These factors may include:
● the patient’s age and health
● the quality and adequacy of blood supply
● chronic conditions such as diabetes and smoking
● immunocompromised state
● inflammation
● coexisting infections and systemic processes
● the comprehensive quality of the soft tissues
● the patient’s adherence to postoperative instructions
Healing is a multifactorial process. Surgery, mechanical and biologic support, wound bed preparation, and postoperative management can all influence healing.
Therefore, a surgical plan should encourage thoughtful consideration of the graft’s attributes. It should also consider the factors that characterize the patient.
Training may include the following:
● Purpose
● Restrictions and considerations
● Storage needs
● Preparations
● Positioning
● Time limitations after opening or thawing
● Tissue tracking
● Documentation needs
Documentation is critically important for human tissue products. Facilities need to note product details and the time of product use. They also need to follow company policy when tracking the product.
Creating Optimal Surgical Workflows with Leading Edge Biologics
Innovative biologic allografts may improve surgery by providing specialty allografts for different needs. These needs can range from temporary wound covers to permanent covers for ligament and tendon tissue healing. They can also include bone repair and nerve regeneration.
Biologic technologies can address individual surgical needs, product specifications, and workflow requirements. The advanced biologic products TEXAGEN® Amniotic Membrane Allograft and ALLOCYTE® Plus Advanced Viable Bone Matrix provide examples.
The strength of the product lies in the combination of selection, preparation, use, and, most importantly, documentation. Surgical teams should use these products within the parameters of product-specific Instructions for Use, evidence-based surgical protocols, and informed clinical judgment from the care provider.
