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Words on Wounds

A forum to discuss the latest news and ideas in skin and wound care.

Monday, October 22, 2018

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A 72-year-old woman with a history of colon cancer underwent a surgical procedure to remove part of her bowel. The remaining portion of the functioning intestine was brought through her abdominal wall, creating an ileostomy. She was managing her ostomy care without any problem, but she has gained a significant amount of weight in the last 6 months, and she presents to your clinic complaining about increased pouch leakage and pain in the peristomal skin. What could be causing the patient's pain?

Peristomal skin complications are common; the incidence is estimated to be as high as 72%. Even after a year or more living with a stoma, many patients continue to experience an array of skin complications, highest among people with ileostomy (57%), followed by urostomy (48%), and colostomy (35%). 

On examination, you notice an erythematous area and skin erosion (partial-thickness skin loss) in the immediate skin surrounding the stoma consistent with irritant dermatitis. You know that the exposure of skin to effluent from an ileostomy that contains a high concentration of digestive enzymes causes skin erosion. The severity and extent of dermatitis is more noticeable in the lower inferior aspect of the stoma, suggesting fecal pooling. This would explain why the patient experienced intense burning and pain. Skin erosion and weeping lesions in the peristomal area create a challenge for the appliance to stick to the skin, creating a vicious cycle of skin irritation, appliance failure, leakage, and more skin irritation. So what precipitated the leakage?

You also notice a change in the abdominal contour, including an out-pouching protuberance around the stoma suggesting peristomal herniation. You know older adults are at risk for herniation, because the rectus abdominus muscle becomes thinner and weaker with age, affecting stoma support. Now, the patient's appliance does not conform to the contour of the herniation. Stretching and relaxing of the peristomal skin with changes in position make it challenging to maintain a good pouching seal. Another possible other reason for increased leakage is related to stoma retraction, because the stoma sits below skin level. 

What can be done to reduce leakage? You ask yourself. Several interventions should considered: 

  • Use soft-convex flange to enable the stoma to protrude more.
  • Consider abdominal support belts or girdles to keep the appliance in place.
  • Avoid heavy lifting and heavy work to prevent further herniation.
  • Recommend exercise to strengthen abdominal muscles.
  • Educate the patient about weight reduction to achieve a body mass index of 20–25.
  • Evaluate the pouching system for the size and fit of the barrier to the stoma to minimize skin exposure to effluent and irritant dermatitis.
  • Trial a two-piece system so the pouch can be changed without removing the skin barrier.
  • Use skin barrier paste or strips to fill or level skin creases/folds or at the areas that are concave under the pouching system.
  • Consider skin barrier paste to caulk the edge of the skin barrier to slow the process of erosion.
  • Consider a cyanoacrylate-based liquid skin protectant to form a protective layer over the damaged skin. Sprinkle skin barrier powder onto the denuded area and apply a liquid polymer acrylate to seal the powder.

Thursday, October 18, 2018

Evaluate use of negative pressure wound therapy in obese and diabetic patients

Patients with higher body mass indices have an increased risk of developing surgical site infections in the abdomen because the majority of these incisions are extensive and deep in order for surgeons to access the treatment areas.  Healing can be complicated by diabetes and excessive skin folds/penus could damage the incision due to unwanted pressure, moisture, and bacteria. Researchers in the University of Illinois at Chicago Epicenter for Prevention of Healthcare Associated Infections received funding from Centers for Disease Control and Prevention to explore whether negative pressure wound therapy can help reduce the incidents of surgical site infections in obese and/or diabetic patients at five university-associated hospitals who have undergone C-sections, abdominal hysterectomy and colon procedures -- three procedures that have elevated rates of incision site infection.  Negative pressure helps increase blood flow to the area, keeps the edges of the incision intact, and draws out excess fluid. The efficacy of negative pressure wound therapy has been evaluated in several small trials, including for promoting healing in cesarean-section incisions, but results have been mixed as to its benefits. This new study will include 3,300 participants in collaboration with the University of Utah, the University of Maryland, Emory University and the University of Iowa.


3D structure of toxic proteins used by Pseudomonas aeruginosa to trigger infection

Pseudomonas aeruginosa infections are a common problem in hospitals. Researchers at Karolinska Institutet, Umeå University and Yale University have mapped the three-dimensional structure of two toxic proteins, called ExoS and ExoT, that the bacteria use to trigger the infection process.  The team found a large, hydrophobic contact interface on the bacterial toxins that is protected by the human protein called 14-3-3.  Otherwise, the toxins form inactive clusters in the cell's water-soluble environment. This newly identified contact interface presents a possible target for drug molecules.


Acelity to buy wound care firm Crawford Healthcare

US-based Acelity has signed an agreement to buy British advanced wound care firm Crawford Healthcare and its assets.  Crawford develops and commercialises treatments for skin care and repair. Its portfolio consists of KerraMax Care foam line, and KerraFoam and KerraCel antimicrobial gelling fibre brands for AWD. The move is intended to expand Acelity's advanced wound dressings (AWD) portfolio and bolster its footprint in the advanced wound healing market.


Smart bandage monitors and treats chronic wounds

Tufts University in the US has led a team of engineers in developing a prototype bandage that can actively monitor the condition of chronic wounds and deliver appropriate drug treatments to improve healing outcomes.  The bandages are designed with microprocessor that tracks data from the sensor and releases drugs on demand from its thermoresponsive drug carriers.  This device allows the delivery of tailored treatments in response to wound pH and temperature sensors that monitor signs of infection.  The entire product is attached to a transparent medical tape, forming a flexible bandage that is less than 3mm thick.  In the future, oxygen levels and inflammatory biomarkers could also be under surveillance.

 

Kent Imaging collaborates with SerenaGroup to improve wound care

Canadian medical technology company Kent Imaging has partnered with US-based wound healing research firm SerenaGroup to enhance wound tissue analysis by using near infrared imaging technology on its non-invasive KD203 device. A hand-held, portable device is designed to provide timely and accurate assessment of oxygen saturation (StO2), relative oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) levels in superficial tissue. The imaging technology delivers 2D colour-coded images that offer the information necessary for clinicians to identify at-risk tissue and aid in making treatment decisions.


CellerateJV to distribute activated collagen adjuvant in the US

Wound Management Technologies operating under WNDM Medical, has entered into a new joint venture with The Catalyst Group to produce its CellerateRX activated collagen assets. The newly formed Cellerate JV will maintain an exclusive sublicense to distribute the CellerateRX activated collagen adjuvant into the wound care markets in the US, Canada and Mexico, according to an SEC filing.


MolecuLight obtains FDA de novo clearance for handheld fluorescence wound imager

Last December, Smith & Nephew launched the MolecuLight i:X handheld imaging device in Europe. The Toronto-based company MolecuLight obtained FDA de novo clearance for its MolecuLight i:X a handheld imaging tool that is designed to assess wound surface area and help visualize harmful bacteria within the wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.

Wednesday, September 26, 2018

The emergence of multi-drug resistant bacteria and concerns about biofilm have rekindled the interest and debate about the use of topical antiseptics. Povidone iodine (10% PVP-I) is one of the most extensively used broad-spectrum topical antiseptics. PVP-I releases free iodine that binds to DNA nucleotides, amino acids in cell membranes, and mitochondrial enzymes, interrupting normal bacterial mitosis and cellular metabolism and eventually leading to cell death. In a recent poll, we asked your opinion about whether PVP-I solution is safe for routine chronic wound care. The results indicate that the majority of respondents consider PVP-I to be unsafe. 

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According to recent literature, biofilm is present in all chronic wounds and this is the main reason why wounds become chronic and fail to follow an expected healing trajectory. Ongoing and robust measures are necessary to curb the proliferation of bacterial burden in chronic wounds and minimize the risk of spreading infection. Many regular antimicrobial agents may not be able to penetrate through exopolymeric substances to destroy bacteria inside biofilm. Povidone iodine is one of the few topical agents that has been shown to penetrate biofilms and have an antimicrobial effect against bacteria, viruses, fungi, spores, and protozoa without acquired resistance.

According to the recent World Health Organization Global Guidelines for the Prevention of Surgical Site Infection (2016), PVP-I 10% is superior to polyhexanide, chlorhexidine, octenidine, and ethanol 80% against a wide spectrum of pathogens. In-vitro evidence suggests that iodine may produce anti-inflammatory effect by inhibiting production of inflammatory mediators and metalloproteinase. The net effect is improved healing outcomes in various chronic wound types including venous leg ulcers, diabetic foot ulcers, and pressure injuries.

While the studies are fraught with many methodological shortcomings--the lack of adequate sample size, sufficient observation time, and apt comparators--repeated local application of PVP-I was well-tolerated and accompanied by demonstrable clinical effectiveness that was comparable to systemic antibiotics and other moist wound dressings.

On the other hand, concerns over allergic reactions and toxic effects on host cells following regular use of PVP-I warrant clinical attention. The majority of these concerns are based on in-vitro or animal studies; findings may not be extrapolated to humans in clinical practice. Most wounds have exudate, microorganisms, and exogenous/endogenous proteins diluting the cytotoxicity of the antiseptic.

In my facility, we have used PVP-I for routine management of nonhealing and maintenance wounds with favorable outcomes to eliminate odor, reduce exudate, and healing of deep tunnels. Dressings (usually gauze) are moistened with (drenched in) PVP-I and put loosely into wounds every day. In some superficial wounds, PVP-I can be "painted" over the area and surrounding skin to reduce bacterial load.

Note that PVP-I may interact with silver molecules and should not be used with silver dressings. To answer the concerns about cytotoxicity and clinical efficacy, randomized controlled studies are needed to shed light on this contentious issue. 

Tuesday, August 21, 2018

Smartphone Cameras to Improve Patient Adherence and Outcomes and Curb Healthcare Expenditures

Healthy.io has announced a new digital health product: Dip.io, which uses smartphone cameras as a clinical grade diagnostic device to test for protein, glucose, and blood in urine. Regular urine testing is required for individuals with a wide range of conditions such as pregnancy, kidney disease, diabetes, high blood pressure. Dip.io is a home-based, smartphone-enabled urinalysis kit that allows patients to conduct urine testing in the privacy of their own home. Considering laboratory testing is time consuming and inconvenient, this new technology could potentially improve patient adherence and save billions of dollars in healthcare expenditures through better access and prevention through early screening for kidney disease. A study initiated by the National Kidney Foundation demonstrated significant adherence improvement based on the Healthy.io adherence-as-a-service platform compared with standard of care. Healthy.io is currently expanding its "medical selfie" portfolio to standardized assessment of chronic wounds.

PICO for Prophylactic Use in Surgically Closed Incisions to Reduce Surgical Site Complications

Complications from surgical incisions are a significant and expensive health problem contributing to significant morbidity and mortality globally. A recent World Union of Wound Healing Societies consensus guideline reports that up to 60% of surgical site infections (SSIs) are preventable. In a recent Medtech innovation briefing, the prophylactic use of the PICO system was recommended to reduce surgical site complications (SSCs), including SSIs and dehiscence of the surgical incision in patients at elevated risk. The PICO dressing has a proprietary AIRLOCK Technology that uniformly and consistently delivers negative pressure wound therapy across a surgical incision and the surrounding zone of injury generated naturally by the incision itself. The dressing is designed to help reduce the risk of wound complications by reducing postoperative fluid, swelling, and associated tension around a closed surgical incision compared with standard dressings. The effectiveness of PICO in reducing SSCs has been examined in 10 RCTs and multiple observational studies. A recently published 1,839 patient meta-analysis demonstrated the efficacy of PICO, used prophylactically, significantly reducing SSIs by 58% in closed surgical incisions compared with standard care.

Mölnlycke Acquires German Wound Care Company SastoMed GmbH

Mölnlycke has acquired German wound care products company SastoMed GmbH, bringing two new and complementary products to Mölnlycke's wound care portfolio:

  • Granulox: a haemoglobin-based topical oxygen therapy spray that is sprayed on wounds to promote wound healing. 
  • Granudacyn: a hypochlorous wound irrigation solution for cleaning, moistening, and rinsing acute, chronic, and contaminated wounds.

Granulox won the 2018 Innovation Award at the European Wound Management Association's Congress in Krakow. Studies report that Granulox can reduce the total cost of diabetic foot ulcer treatment by around 60% a year.

Compound to Reverse Skin Changes Associated with High Dietary Intake of Fat and Cholesterol

Johns Hopkins investigators developed a new compound, D-threo-1-phenyl-2-decanoylamino-3-morpholino-1-propanol (D-PDMP) and used it to successfully reverse hair loss, hair whitening, and skin inflammation. The compound deters the production of certain fats called glycosphingolipids that are major components of skin and other cell membranes. High dietary intake of fat and cholesterol is responsible for hair discoloration, extensive hair loss, and inflammation of skin exhibited by multiple wounds. The research team found that mice eating a Western diet high in fat experienced an infiltration of neutrophils, a type of white blood cell implicated in inflammation, in various skin areas. Treatment with D-PDMP in a capsule significantly reduced the number of neutrophils, implying reduced skin inflammation and wounding.

Autologous Cell Harvesting Device for the Treatment of Burns

AVITA Medical announced its plans to launch RECELL Autologous Cell Harvesting Device in the treatment of burns. The RECELL Device is an investigational medical device in the U.S. that is designed to produce a Regenerative Epidermal Suspension at the point-of-care using a small sample of the patient's own skin. The autologous suspension contains cells necessary to regenerate epidermis and reduce the amount of donor-site skin. A premarket approval application for the treatment of burn injuries is currently under review by the U.S. FDA.

Nanofiber-based Wound Dressings with Vitamin D

Oregon State University researchers have developed a nanofiber-based wound dressing containing the bioactive form of vitamin D (1,25-dihydroxyvitamin D3) to induce the production of a peptide (hCAP18/LL37) that kills microbes by disrupting their membranes. Because the dressings work by enhancing innate immune responses rather than by containing conventional, single-target antimicrobial compounds, they are less likely to contribute to drug resistance. The research team used electrospinning to generate nanofiber wound dressings that are superior to hydrogels for local drug delivery.

Nexodyn AcidOxidizing Solution for Healing Chronic Wounds

APR Applied Pharma Research announces the publication in Advances in Skin & Wound Care (April 2018) of the results of a clinical pilot study on the efficacy and tolerability of Nexodyn AcidOxidizing Solution (AOS). AOS is a sprayable cleanser with that helps normalize the pH of chronic wounds and promote biochemical reactions as part of the healing process. The pilot study was conducted with a prospective, single-arm design. Thirty patients with critically colonized or locally infected chronic leg ulcers in Austria were recruited. AOS was applied on each leg ulcer at every dressing change for 35 days together with a nonadherent gauze and a multi-purpose absorbent dressing. By the end of the study period, treatment with AOS led to the full healing of 37% of the chronic wounds as well as to a significant decrease in wound size (P < .001). No adverse events were reported over the study duration, and patients reported high levels of pain relief and comfort.

Tuesday, June 26, 2018

​Regenerative Bandage Using Fragment of Leminin

A Northwestern University team has developed a regenerative bandage that can promote the healing of diabetic ulcers 33% faster than one of the most popular bandages currently on the market. The scientists identified a segment of laminin (12 amino acids in length) called A5G81 that is critical for the wound-healing process. The protein, A5G81, is found in most of the body's tissues including the skin and it sends signals to cells, encouraging them to differentiate, migrate, and adhere to one another, creating a scaffold that facilitates the body's ability to regenerate tissue at the wound site. The regenerative bandage incorporates an antioxidant, anti-inflammatory hydrogel that is thermally responsive; it is a liquid when applied to the wound bed, then rapidly solidifies into a gel when exposed to body temperature. This phase change allows it to conform to the exact shape of the wound. The material can be rinsed off with cool saline, leaving the regenerating tissue undisturbed. By using a small fragment of laminin rather than the entire protein, it can be easily synthesized in the laboratory, making it more reproducible while keeping manufacturing costs low.

Nanoparticles for the Detection of Excessive Scarring

Excessive scarring can dramatically affect a patient's quality of life, both physically and psychologically, as the scars can impede movement and activity, and can be painful when stretched. Over 100 million patients in developed countries develop scarring problems annually, arising from 80 million elective and trauma surgery operations. Joint research from Nanyang Technological University in Singapore (NTU Singapore) and Northwestern University in the United States has shown (using animal and human skin samples) that new nanoparticles have the potential to quickly and accurately predict whether a wound is likely to lead to excessive scarring such as keloids and skin contractures. These nanoparticles (NanoFlares) with tiny DNA strands targeting particular genes are applied to closed wounds using a cream. After the nanoparticles have penetrated the skin cells for 24 hours, a handheld fluorescent microscope is used to look for signals, given out by the nanoparticles' interaction with target biomarkers inside the skin, that indicate abnormal scarring activity. NanoFlares could be a supplementary tool to monitor and analyse other skin diseases, such as skin cancer, because the DNA sequences on the nanoparticles are interchangeable.

Gel-based Dressing to Stop Bleeding

Researchers from the Department of Biomedical Engineering at Texas A&M University are developing an injectable hydrogel bandage combining a hydrogel base (a water-swollen polymer) and nanoparticles that interact with the body's natural blood-clotting mechanism. The hydrogel expands to stop bleeding by sealing the injured area while the surface of the nanoparticles attracts blood platelets that facilitate the natural clotting cascade of the body. In addition to the rapid clotting mechanism of the hydrogel composite, the engineers use the electric charge of the nanoparticles to add vascular endothelial growth factor (VEGF) that efficiently adhere to the particles. They tested the hydrogel/nanoparticle/VEGF combination in a cell culture test that uses a petri dish with a layer of endothelial cells on the surface to create a solid skin-like sheet. The sheet is then scratched down the center creating a rip or hole in the sheet that resembles a wound. When the hydrogel-containing VEGF bound to the nanoparticles was added to the damaged endothelial cell wound, the cells were induced to grow back and fill-in the scratched region, essentially mimicking the healing of a wound.

AcidOxidizing Solution to Fight Infection

APR Applied Pharma Research sa (APR) announces the publication in Advances in Skin & Wound Care (April 2018) of the results of a clinical pilot study on the efficacy and tolerability of Nexodyn AcidOxidizing Solution (AOS). Nexodyn Antimicrobial Wound Care Solution is an active wound cleanser that is effective on the modulation of the inflammatory mediators while offering an excellent tissue safety profile combined with bioburden control. The cleanser is differentiated by its highly pure hypochlorous acid (HCIO) (> 95% of the free chlorine species), low pH, and high oxidation-reductions potential (ORP). The pilot study included 30 patients with critically colonized or locally infected chronic leg ulcers of any origin in Austria. AOS was applied on each leg ulcer at every dressing change for 35 days together with a nonadherent gauze and a multi-purpose absorbent dressing. By the end of the study period, treatment with AOS led to the full healing of 37% of the chronic wounds as well as to a significant decrease in wound size (P < .001).

Acelity Acquires Crawford Healthcare

Wound care company Acelity has agreed to acquire UK-based wound care and dermatology firm Crawford Healthcare. Crawford Healthcare produces wound dressing products, including the superabsorbent KerraMax Care range, KerraFoam, and KerraCel foam and antimicrobial gelling fiber AWD range.

​Topical Nitric Oxide for Wound Care

EDX110 is a sustained-release nitric oxide (NO)-generating medical device that can be delivered as a dressing, liquid, gel or inhaled spray. NO is involved in many physiological processes including vasodilatation and angiogenesis, inflammation, and antimicrobial activity. Laboratory tests have shown EDX110 rapidly and safely kills bacteria, viruses, and fungi, including several deadly antibiotic-resistant infections, such as MRSA and E. coli. EDX110 was evaluated in a multi-center, prospective, observer-blinded, parallel group, randomized controlled trial involved 135 participants with 148 ulcers (EDX110 - 75; Control - 73). Participants randomized to EDX110 achieved a median percentage area reduction of 88.6% compared with 46.9% for the control group (P = .016) at 12 weeks, 30% of which were clinically infected at baseline. EDX110 also increased the number of completely healed ulcers by more than 50% (49% vs. 30%), nearly doubling the complete healing of infected ulcers (45% vs. 23%) and significantly reducing hospitalisations and serious adverse events related to the ulcer compared with standard-of-care at 12 weeks. ​