There is a certain group of people who can run miles-long marathons, climb a near-vertical rock face, then change their prostheses and do it again.
Advances in technology brought this to life for amputees, turning what was previously impossible into what is modern day reality. But while the ideal fit of a limb could put this mobility within grasp, wound complications after amputation could take it just out of reach.
Many amputations do not heal in primary fashion, Jason Kahle, MSMS, CPO, FAAOP, chief executive officer of OP Solutions Inc., told O&P Business News. Factors such as age, nutritional status and tobacco use could affect the healing process.
“Each amputation is different,” he said. “But they all have a suture site…basically an open area to the body. If that wound becomes bigger, it could have implications [for] the skin, granulation of the tissue or worse, cause an infection.”
Bacterial infection could lead to further complications. Severe bruising, inflammation, cellular damage, swelling and dehiscence could occur. It could even progress to the bone if it remains untreated, Kahle said.
“If the bone becomes exposed then osteomyelitis could set in…[and] the most common fix is a bone revision – meaning a further amputation.”
Image: Lee C. Rogers
When the amputation is performed at a higher level, it becomes more difficult to rehabilitate, Lee C. Rogers, DPM, executive medical director of the Amputation Prevention Center at Sherman Oaks Hospital, told O&P Business News.
“A more proximal amputation decreases the patient’s activity and increases the energy necessary to ambulate, which makes prosthetic rehabilitation challenging,” he said. “That is why it is critical to move rapidly in at-risk patients…in order to prevent that outcome.”
Management and care
That is what clinics are hoping to do, Rogers said, and there are six stages of care that could help them achieve it.
“In the life cycle of wound treatment…you have six defined steps. The first is infection diagnosis and management, the second is vascular diagnosis and management, and then relieving pressure or offloading is the third,” he said. “The fourth step is regular debridement, the fifth is promoting granulation tissue and the final step is wound closure.”
Following these stages is not always easy, but a wave of new technology is making it possible, Rogers said.
Through the use of negative pressure wound therapy, clinics can secure the residual limb in a sterile environment and with ultrasonic debridement, can vibrate excess debris away from healthy tissue.
Javier La Fontaine
“It is like a vacuum,” Javier La Fontaine, DPM, MS, associate professor of plastic surgery at the University of Texas Southwestern Medical Center, told O&P Business News. “It suctions fluid, decreases bacterial load and promotes new vessel formation.”
“A lot of companies have come up with their own version of it,” Rogers added. “We can now manage very complex wounds without having to do flaps or other surgeries that a patient may not be a candidate for.”
When non-viable tissue is completely removed, antiseptic dressings are introduced. Dressings are built with absorbent, antimicrobial materials including zinc, iodine or petrolatum. This provides an ideal environment to optimize healing and gradually strengthen the suture site.
In more severe cases, silicone or synthetic skins and liners are used, which could rebuild damaged tissue and reduce the likelihood of infection.
“Some liners are even temperature controlled or self-adjusting,” Kahle said. “You could argue that if these types of coverings are used once an ulcer or small irritation occurs, it could help prevent the wound altogether. However, a well fitted prosthetic socket is the best chance to prevent skin breakdown.”
Hygiene could also prevent skin breakdown, Terrence Sheehan, MD, medical director at the Amputee Coalition and chief medical officer at the Adventist Rehabilitation Hospital, told O&P Business News.
“It is extremely important. Keeping yourself clean, keeping the prosthesis clean, the liners, sockets and anything else that comes in contact with the skin – it is vital for amputees to pay close attention to that.”
The more knowledge patients have about their care, the better their outcome could be, Sheehan said.
“It is about helping to educate the person…really identifying the cause of an issue and helping them understand the gravity of it. That means regular surveillance and close managing,” he said.
“We have to be diligent in making sure the surgery site heals and that no skin breakdown happens. Treating someone’s wound could be basic care…a lot of times as simple as a Band-Aid. But there is always a reason why the skin opened to begin with. In order to prevent it, you have to know the cause.”
Medical barriers in treatment
Sometimes the cause is internal, Rogers said. While most wounds progress through the six stages of care, others are stalled if the patient has additional health complications.
“After the amputation, risk factors are highlighted by the patient’s general health,” he said. “People with disease, like poorly controlled diabetes, are not only at risk for further amputation, but wounds and ulcers as well.”
Nearly 85% of diabetic amputations are preceded by an ulcer, La Fontaine said. Patients with diabetes are also five times more like to have a postoperative infection, and circulatory-related problems increase their chance of non-healing wounds, according to Complications of Lower Extremity Amputations.
“Diabetes affects your immune system, so you cannot fight infection efficiently,” La Fontaine said. “You do not have a good blood flow…because the disease disrupts your circulation.”
“A good circulatory system is imperative to heal,” Kahle added. “It is how white blood cells and oxygen get to the area. Diabetes is basically a detriment to that system…it compromises healing rate and effectiveness.”
Diabetic patients could also develop neuropathy, a type of nerve disease that causes a lack of protective sensation. “If something is wrong in the foot, they would not notice it early because they do not feel the pain,” La Fontaine said.
Peripheral vascular disease could also obstruct healing, he added.
“People with peripheral vascular disease are predisposed to poor wound healing and skin closure. People with immunological medical and connective tissue diseases are predisposed to poor healing as well.”
Even malnutrition could negatively affect healing, according to Factors Affecting Wound Healing After Major Amputation for Vascular Disease: A Review.
A high demand for nutrient intake coupled with a reduced ability to retain nutrients place amputees at high risk for malnutrition, the study found.
Clinical factors also play a role in healing. If a dressing is improperly applied, it could cause blister formation, swelling and restrict movement of the limb. If a patient’s weight fluctuates and the prosthesis becomes misaligned, it could lead to increased tension, friction, disruption in blood flow and ulceration.
Lee C. Rogers
“The incision line may not be in the ideal location,” Rogers said. “It may lie in an area that causes pressure from the prosthesis, or maybe there is not enough soft tissue and muscle coverage over a tibial stump.”
But even if the limb is securely fit into a prosthesis, infection could still develop, Kahle said. Abnormal mechanical and thermal conditions within the socket subject the skin to breakdown and irritation.
“When a person starts walking on a prosthesis, their skin is very fragile. If they need to work every day or provide a living, they are probably going to continue to ambulate,” he said.
“The wound could potentially open or become bigger…[and] because a prosthesis is the perfect environment for bacteria, they could get an infection just by wearing it.”
Functional barriers in treatment
It is unlikely the patient will receive a new device, Kahle added. While a new device or treatment could resolve an issue, it may not be reimbursed by their insurance company.
“If someone came here and had an ulcer…[for instance, if] they lost some weight or were not wearing enough socks, their insurance might say, ‘We are not going to pay for a new prosthesis because we just fit one,’” he said. “They limit our choices for providing additional treatment…and that takes some of the better options away.”
“Even if we have a treatment available in the clinic, if the patient has no medical coverage, they would need to pay out of pocket,” La Fontaine added. “Coverage and reimbursement are two of our biggest barriers.”
Another barrier is training, he said. Many wound care centers use home health agencies to care for patients after discharge. Specific modalities are needed for the healing process, but nurses are sometimes not properly trained to use them, he said.
“There are clinical and educational barriers,” Rogers added. “But most of it is education. Even if it a clinical issue, it is still and educational issue. We need more training, more funding and more education.”
The next era
The O&P industry is working toward that, La Fontaine said. Healing a wound is a continuous process, and one that requires multiple dimensions of care.
“Clinics need have a multispecialty approach – a team of experts rather than just one doctor. There should be someone for each component of the wound…and if we can negotiate pricing [with third party payers], it could be a win-win situation for everyone.”
Wound complications have moved into a new era, he said, and are demanding more sophisticated technologies. Research is being done in that direction, and new tools are beginning to break the surface.
Clinics have begun the use of vacuum assisted suspension. This socket-suction system is incorporated in the prosthesis, and could enable better distal blood circulation and fewer dressing changes.
“The wound vacuum has probably been the best invention for healing because we can save very big, complex wounds,” Rogers said.
“New vacuum assisted technology can be advantageous,” Kahle added. “It may establish the protocol for wearing a prosthesis with an open wound.”
Hyperbaric oxygen treatment is also being introduced. This method could offer added assistance in healing, particularly in chronic wounds that have not responded to other treatment.
“It depends on the depth of the wound or ulcer, but…hyperbaric treatment is an option to get the skin closed,” Sheehan said. “It gives a high concentration of oxygen to the patient, which help promote healing.”
The limb is placed in a sealed chamber and exposed to 100% oxygen over the course of multiple treatments. The oxygen is forced into the blood stream, which could prevent tissue loss and shorten the healing timeframe.
“Hyperbaric oxygen is expensive care,” Sheehan said. “It often requires numerous treatments to be effective. You have to have the right indication of when to use it…and that is why it is typically done through a specialty wound care center.”
There are more novel technologies on the way, La Fontaine said, such as the use of ultraviolet light.
“Ultraviolet light is a unique, non-contact technology that may decrease bacterial load on wounds,” he said. “There is new research saying bacteria are important predators in preventing wounds from healing…so, it is becoming an area of interest as far as decreasing bio-burden.”
There are new techniques in skin grafting, Rogers added. Surgeons are able to harvest an epidermal skin graft from the thigh of a patient and transfer it anywhere else on the body. This allows healthy cellular tissue to be placed on a wound, creating a life stimulating bridge to the wound on the residual limb.
“There has also been an explosion of amniotic tissues in the market,” Rogers said. “The benefit of amniotic tissue is that it is non-immunogenic, so you can transplant from another human being and it will not cause an immune reaction. [It can be used to] cover exposed tendon or bone…and has a lot of growth factors to spark new healing.”
Rogers believes stem cell therapy and gene therapy are looming in the future of care, and could become a future standard of treatment.
The wound care field is rapidly expanding, Sheehan added. Collaboration and research have become more important than ever.
“It will take hard work and dedication, but the quicker someone is healed, they quicker they can be fit for a prosthesis,” he said. “The quicker they are fit with a prosthesis, the quicker they can get back to life.” – by Shawn M. Carter
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Disclosures: Kahle, LaFontaine, Rogers and Sheehan report no relevant financial disclosures.