Surgeons share how they evaluate whether a wound bed is ready for either an acellular dermal matrix or a skin graft
As he cruised down Highway I-20 in Atlanta with his friends, 20-year-old Jalen Richardson didn’t have a care in the world. Without warning, another motorcycle struck his back tire, projecting him down the road, his bike skidding along with him. The impact punctured his bike’s gas tank and before long he became enveloped in a fiery cloud of flames and ash and soot, struggling just to move, to breathe, to escape.
He couldn’t comprehend the pain he felt, how badly his body was injured, or the fact that his riding jacket, meant for protection, was now physically affixing him to the fiery road below.
Richardson had always lived a life of excitement, commitment, and passion. A natural athlete, he played football, baseball, and wrestled in high school. He was involved in his school’s ROTC program for all four years, and signed up for the military after he graduated, becoming an Army National Guardsman.
But after the accident, this once vibrant, healthy young man with so much promise became a shell of his former self – a person he barely recognized. Richardson had sustained third-degree burns to 60% to 70% of his body. His left arm and bicep muscles had been incinerated.
Dr. Juvonda Hodge, assistant medical director at Grady Memorial Hospital Burn Center, knew that Richardson’s road to recovery was going to be a long one – and painful at that. She began the incredibly painful process of burn care – debriding dead tissue, pumping him with fluids, and, most importantly, helping him build new skin.
After making the difficult decision to amputate Richardson’s left arm, Dr. Hodge used Integra Dermal Regeneration Template to fill in missing pieces of skin, she says, to protect these areas against further damage and infection and allow his own skin cells to proliferate and regenerate.
“We were able to put Integra on the remainder of his amputation stump and grafted it,” Dr. Hodge says in the video above. “You have to have a good foundation is what I always say. Integra gives you that great foundation to start grafting on top of that.”
After countless surgeries, bouts of depression and anxiety, and help from a few canine therapy companions, Richardson slowly but surely began to return to his former self. As his skin grew, so did his determination to heal, thrive, and succeed.
By 2020 – four years after the accident — Richardson had not only returned to his unit at the Georgia National Guard, he was named the 78th Aviation Troop Command’s “Soldier of the Year.”
“I think his story was just so…remarkable,” Dr. Hodge recently told Emory Medicine magazine in their recent feature on Richardson, “Man on Fire.” “I hate to say miraculous, but it was miraculous, as far as you don’t see a lot of people who come back from that darker place to that high of function.”
Read below for more information about Integra Dermal Regeneration Template:
Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.
Integra template is also marketed as Integra® Omnigraft™ Dermal Regeneration Matrix. Omnigraft is indicated for the use in the treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic care.
Use of Integra template is contraindicated in patients with known hypersensitivity to bovine collagen or chondroitin materials. Integra template should not be used on clinically diagnosed infected wounds.
Warnings and Precautions
Excision of the wound must be performed thoroughly to remove all coagulation eschar and nonviable tissue. Integra template will not “take” to nonviable tissue. Leaving any remaining nonviable tissue may create an environment for bacterial growth.
Hemostasis must be achieved prior to applying Integra template. Inadequate control of bleeding will interfere with the incorporation of Integra template.
There have been no clinical studies evaluating Integra template in pregnant women. Caution should be exercised before using Integra template in pregnant women. Such use should occur only when the anticipated benefit clearly outweighs the risk.
In clinical trials, the use of Integra template was evaluated in a small number of patients with chemical, radiation, or electrical burns. A surgeon’s decision to use Integra template on these wounds should be based on their evaluation of the wound and its suitability to excisional therapy, the likelihood that a viable wound bed will be created by excision, and whether the possible benefit outweighs the risk in this patient population.
The extent of scarring associated with the use of this product has not been determined.
Integra template has been found to be well tolerated in 4 prospective clinical trials involving 444 burn patients. There were no reports of clinically significant immunological or histological responses to the implantation of Integra template. There were no reports of rejection of Integra template.
Adverse events reported in the Integra template clinical trials include death, sepsis, apnea, heart arrest, pneumonia, kidney failure, multisystem failure, and respiratory distress. With the exception of wound fluid accumulation, positive wound cultures, and clinical wound infection, none were directly related to the use of Integra template.
In these clinical trials, data were collected regarding wound infection. The consequences of infection at sites treated with Integra template included partial or complete loss of take (incorporation into the wound bed) of Integra template. Infection rates in sites treated with Integra template in these three clinical trials supporting the PMA ranged from 14 to 55%. The overall infection rate for the Postapproval Study was 16.3%.
Adverse events in the Postapproval study were similar to those observed in the previous clinical trials and are common in populations of critically ill burn patients regardless of type of treatment used.
There were no trends noted. There were six adverse events which were rated by the investigator as being related. These events were all single occurrences except for sepsis (2). These adverse events occurring in <1% of the safety population.
Incidence of adverse events occurring in >1% of the safety population in the Post-approval Study are as follows: Sepsis (23.1%), Death (13.9%), Infection (2.8%), Thrombophlebitis (2.8%), Kidney Failure (2.8%), Necrosis (2.3%), Hemorrhage (2.3%), Heart Arrest (1.9%), Apnea (1.9%), Pneumonia (1.9%), Allergic Reaction (1.4%), Fever (1.4%), Multisystem Failure (1.4%), Atrial Fibrillation (1.4%), Gastrointestinal Hemorrhage (1.4%), Kidney Abnormal Function (1.4%).
Contracture Release Patients
The following adverse events were reported in a Reconstructive Surgery Study involving 20 patients with 30 anatomical sites and a Retrospective Reconstruction Contracture Survey involving 89 patients and 127 anatomic sites.
Incidence of adverse events in the Reconstructive Contracture Surgery Study and Retrospective Contracture Reconstruction Survey are as follows: Infection (0.0%), Fluid under Silicone Layer (0.0%), Partial graft loss (Integra) (0.0%), Failure to take (Integra) (0.0%), Shearing/Mechanical shift (3.3%), Hematoma (16.7%), Granulation tissue formation (0.0%), Delayed Healing (0.0%), Separation of the Silicone Layer (0.0%), Seroma (0.0%), Pruritis (0.0%), Epidermal autograft loss >15% (6.7%), Epidermal autograft loss <15% (23.3).
There were no infections reported in the Reconstructive Surgery Study and the reported infection rate was 20.5% in the Retrospective Contracture Reconstruction Survey. No deaths were reported.
Diabetic Foot Ulcer Patients
All adverse events that were reported in the study evaluating Omnigraft for the treatment of diabetic foot ulcers at a frequency of ≥ 1% in either cohort are presented in Table 1 in the Instructions for Use.
The most common adverse events experienced by patients treated with Omnigraft were: wound infection (15%); new, worsening, or recurring wounds (14%); pain around the wound (9%); infection beyond the wound (either cellulitis or osteomyelitis, 14%); swelling (5%); nausea (5%); worsening health condition (4%). These adverse events occurred in a similar or lower percentage of patients treated with Omnigraft compared to patients treated with standard wound care alone.
The sale of Integra template is restricted to clinicians who have completed a company sponsored training program. Product training is available at ilstraining.com.