Oral and 1st Place Abstracts at 2019 SAWC Fall

Brenda Curtis, PhD; Jin Ok, BS; Anthony Frel, PhD; Martha Roman, BS; and Debashish Chakravarthy, PhD

The opportunistic pathogen Candida albicans is the leading cause of cutaneous candidiasis, including common superficial skin infections like intertrigo and diaper dermatitis (diaper rash). Comorbidities, including obesity and diabetes; treatment with antibiotics, chemotherapy, or steroids; and immunosuppression contribute to elevated risk of skin candidiasis. To relieve common discomforts associated with superficial fungal infections, including itching, cracking, redness, burning, irritation, and chafing, topical antifungal ointments can be applied to the skin surface. Some treatments require a prescription, such as those with the active ingredient nystatin, while others are available over the counter, such as ointments containing 2% miconazole nitrate. Following standard guidelines (ASTM E2315-16, ASTM E1054-08), time kill procedures were performed for quantitative assessment of antifungal activity of white petrolatum-based ointments containing no active ingredient (Soothe and Cool Barrier Ointment; Medline Industries, Inc, Northfield, IL), nystatin (100 000 units/g; NDC: 0472-0166-30; Actavis Pharma, Inc, Parsippany, NJ), or miconazole nitrate (2%; Remedy Phytoplex; Medline Industries) against C albicans (ATCC 10231). Equal amounts of ointments were aseptically measured and then inoculated with C albicans in simulated wound fluid. Samples were immediately neutralized (time zero) or incubated in a humidified 35°C to 39°C incubator until neutralization at time points 6, 12, and 24 hours, followed by enumeration. Samples were tested in triplicate and the mean log reduction between inactive control and test samples was calculated for each time point. The nystatin-containing ointment resulted in mean log reductions of 0.05, 1.08, and 2.50 at 6, 12, and 24 hours, respectively. The miconazole nitrate-containing ointment was slightly more effective, resulting in mean log reductions of 0.08, 1.31, and 2.8 at 6, 12, and 24 hours, respectively. These results demonstrate that both ointments effectively kill more than 99% of C albicans by 24 hours, an important finding since over-the-counter treatments are often cheaper and more readily available to patients with cutaneous candidiasis infections.

*Oral Abstract

Oscar M. Alvarez, PhD; and Mark Granick, MD

Objective: The aim of this case series was 2-fold: (1) to study the absorptive profile of a new multilayer wound dressing (MBF; Mepilex Border Flex; Mölnlycke Health Care, Gothenburg, Sweden) designed to spread wound fluid away from the wound; and (2) to evaluate how treatment with MBF affects the balance of proteases in venous leg ulcers (VLUs) as they heal. 

Materials and Methods: This was a pilot evaluation involving 10 patients with VLUs treated with MBF and standard compression therapy. All patients had adequate arterial circulation (ankle-brachial index > 0.75) and no signs of infection; all VLUs measured less than 25 cm². There were weekly follow-up visits for wound measurement and clinical evaluation. Wound fluid was obtained at baseline (day 0 prior to initial treatment) and once weekly (from the wound and the wound dressing) for 4 weeks. Homogenates were analyzed using a custom multiplex kit for MMP-9. 

Results: After treatment with MBF, mean MMP-9 levels decreased 46% in 2 weeks (P = .042) and 79% in 4 weeks (P = .029). Significant levels of MMP-9 also were detected in the spreading layer and retention layer of MBF. Further analysis of MBF revealed transport of MMP-9 distally (up to 4 cm) away from the wound. 

Conclusions: The MBF effectively transports chronic VLU exudate away from the wound and into the distal spreading and retention layers with minimal swelling. It also draws the chronic exudate distally and away from the wound and wound margins. 

*Oral Abstract

Charles Lee, MD

Aim: This study assessed the economic savings when using a single-stage, single-patient negative pressure wound therapy (NPWT; Invia Motion NPWT; Medela, McHenry, IL) system over an advanced biomatrix (Integra Bilayer Wound Matrix; Integra LifeSciences Corp, Plainsboro, NJ) and skin graft for accelerating the wound healing process by avoiding a second operation and evaluating ease of transition from inpatient to outpatient status. Advanced biomatrix is normally performed as a 2-stage procedure, with one operation to place the biomatrix and another performed 3 weeks later for the split-thickness skin graft (STSG). The authors demonstrate their technique and results in 10 consecutive patients. 

Methods: Biomatrix (Integra Monolayer Wound Matrix; Integra LifeSciences), STSG, and NPWT (-125 mm Hg) were utilized in patients for complex radial forearm free flap donor site reconstruction in a single-stage procedure. The authors assessed the cost stemming from the single-stage procedure versus the standard 2-stage procedure. 

Results/Discussion: Patients treated with the single-stage biomatrix, STSG, and NPWT were all discharged on postoperative day 5. They were easily transitioned from the inpatient status to the outpatient/home setting and had the NPWT device removed in 10 to 14 days. Mean graft take was 98% with no infections. A second operation was not necessary for the STSG and there was no delay in discharge. The cost of the second STSG operation ($10 000) and potential 1 to 2 days in the hospital for discharge ($1500/day) were avoided. 

Conclusions: Use of single-stage biomatrix, STSG, and NPWT resulted in successful reconstruction of large, complex radial forearm free flap donor sites used in phalloplasty. Using the portable, single-patient NPWT device allows for easy discharge of the inpatient and avoids a costly second operation to place a STSG. The single-stage procedure can be considered a superior, cost-effective alternative to the current 2-stage procedure.

*Oral Abstract

Windy Cole, DPM; and Stacey Coe, CRC

Introduction: Optimal wound bed preparation consists of regular debridement to remove devitalized tissues, reduce bacterial load, and establish an environment that can promote healing. A novel point-of-care fluorescence imaging system (MolecuLight i:X; MolecuLight, Toronto, ON, Canada) aids in bacteria-targeted debridement and bioburden management in the treatment of chronic wounds. This observational case series investigated use of this imaging device to target debridement and promote wound healing. 

Methods: Eleven chronic lower extremity wounds were imaged weekly with the device for (1) bacterial fluorescence and (2) wound area over 12 weeks or until healing or lost follow-up. Images positive for bacterial fluorescence (regions of red or cyan) were used to guide debridement to those specific regions. Data from each assessment were categorized as fluorescence positive assessment or fluorescence negative assessment, and slopes of wound area weekly percent changes were calculated from linear regressions for each categorization. 

Results: Of the 11 wounds, 6 healed during this 12-week assessment. At week 1, average wound area was 8.1 cm² and 10 of 11 wounds exhibited red fluorescence. Bacterial fluorescence persisted, on average, for 3.7 weeks, and no wounds healed or entered a healing trajectory while red fluorescence was present. Information gained from fluorescence images provided information to better debride the affected area to the appropriate level. In 9% of cases, this additional debridement resulted in a higher billing code. On average, weekly percent change in wound area increased (6.5 ± 10.8) during periods with bacterial fluorescence and significantly decreased (-27.7 ± 10.1; P = .048) once targeted debridement and other treatments had eliminated the fluorescing bacteria. 

Conclusions: Results suggest fluorescence had a beneficial effect on reducing bacterial load and promoting wound healing. This case series suggests incorporation of fluorescence guidance into standard of care could result in healing trajectories, improved patient outcomes, more appropriate treatment, and increased revenues in the outpatient wound centers.

*Oral Abstract

David G. Armstrong, DPM, MD, PhD; Dennis Orgill, MD, PhD; Robert Galiano, MD; Paul Glat, MD; and Charles M. Zelen, DPM

Introduction: Venous stasis leg ulcers (VLUs) are a significant burden on the worldwide health care system and often refractory to standard of care. A novel autologous homologous skin construct (AHSC; SkinTE; PolarityTE, Salt Lake City, UT) using the patient’s dermal regenerative cellular populations was developed to close difficult-to-treat wounds and assessed in a pilot study setting. 

Materials and Methods: Ten VLUs, all refractory to at least a month of conservative care, were were treated with a single application of AHSC. A 1.5 cm² proximal calf harvest of full-thickness skin was collected in the clinic and sent to a US Food and Drug Administration-registered facility, where it was processed into AHSC and returned to the provider within 48 hours. The AHSC was spread evenly across the wound and then dressed with silicone, secured with adhesive strips, and bolstered with an absorbent foam covered by a triple-layer compression wrap. Healing was documented with digital photography and planimetry during weekly dressing changes. Wound closure was verified 2 weeks following initial closure documentation. 

Results: All 10 wounds (100%) had complete graft take 1 week after ASHC application. All VLU wounds demonstrated granulation and progressive epithelialization shortly after AHSC deployment. Of the 10 wounds, 9 (90%) closed within 12 weeks of a single application of AHSC. A 12.2 cm² wound that had been open for 11 months and failed a prior split-thickness skin graft closed in 13.4 weeks after AHSC therapy. All wounds remained closed at 2-week durability follow-up. All full-thickness skin donor harvest sites remained closed with minimal morbidity. 

Conclusions: The AHSC successfully closed VLUs refractory to dressing care with a single application in this pilot study, warranting further evaluation with randomized controlled trials.

*1st Place Case Series/Study Category

James H. Holmes IV, MD; Lee D. Faucher; and Steven E. Wolf

Introduction/Background: Excision and autografting is the standard of care for many burns. A viable engineered skin tissue (VEST; StrataGraft; Stratatech, a Mallinckrodt Company, Madison, WI) is being developed to reduce or eliminate the need for autograft in the treatment of thermal burns, thereby decreasing donor site morbidity. 

Methods/Design: To evaluate the safety and efficacy of a VEST, a clinical trial (NCT01437852) was conducted in burn centers involving 30 patients with deep partial-thickness (DPT) burns. Comparable burns on each patient were randomized to receive either VEST or a control autograft following excision. Patients were enrolled in 3 cohorts: cohorts 1 and 2 (n = 10 each) received refrigerated VEST (≤ 220 cm² and ≤ 440 cm², respectively) and cohort 3 (n = 10) received cryopreserved VEST (≤ 440 cm²). Here the authors report a post hoc analysis that evaluated outcomes stratified by the size of the VEST treatment area (< 200 cm² vs. ≥ 200 cm²). 

Results/Findings: By day 28, no patient in any cohort underwent autografting at the VEST treatment site. By 3 months, the mean percent of the VEST treatment site that received autograft was 1.7% ± 6.5% and 7.1% ± 26.7% (< 200 cm² and ≥ 200 cm² groups, respectively). By 3 months, 100% (15/15) of the patients in the < 200 cm² group and 86% (12/14) of the patients in the ≥ 200 cm² group achieved wound closure. Mean percent reepithelialization of the VEST treatment site was not statistically different from the autograft control site in both treatment size groups by day 28 (P ≥ .25). 

Conclusions/Implications: A novel VEST has the potential to promote wound healing in patients with DPT burns without the need for autografting. This post hoc analysis demonstrated the use of VEST results in substantial wound closure without autograft at 3 months. A phase 3 open-label, controlled, randomized study (NCT03005106) is ongoing. 

*1st Place Clinical Research Category

Jennifer Lynn Turner, MSN-Ed, APRN, FNP-BC, CWON; and Cindy Demniak, APRN, FNP-BC

More than 50% of pressure injuries occurring in the pediatric and neonatal populations are directly related to medical devices. Skin integrity alteration in the pediatric population causes physical pain for the child, mental anguish for the parents, and increased cost to health care institutions.

Identified recurrent pediatric impaired skin integrity at a Magnet-designated children’s hospital became the focus for this guideline development initiative. In most health care institutions, pediatric treatment and prevention guidelines are adapted from adult practices. Concerns arise for the safety, cost effectiveness, and clinical efficacy due to anatomic and physiological differences between the 2 populations.

Guideline development included: assessing the at-risk patient, determining support surface availability, and choosing support surface functionality to provide moisture management with pressure redistribution. Algorithm development incorporated Braden Q, Neonatal Skin Condition Score, and/or Neonatal Abstinence Syndrome Score. Additionally, the algorithm guided the provider based on spinal stability, patient mobility, paralytics/vasopressors, and respiratory support. Based on the assessment and patient weight, the provider was guided to select the proper low air loss (LAL) support surface, fitted for the appropriate crib, pediatric frame, or cardiac surgical platform. 

Based on study outcomes, the LAL guideline development provides early identification of the at-risk pediatric population. Early identification and surface initiation mitigate the causative factors and improve patient outcomes. Following Institutional Board approval, the retrospective chart review included 3 patients using LAL. In each of the cases, patient healing was evident within the first 10 days of use. After LAL was initiated, additional skin breakdown did not occur during the patients’ hospitalization.

*1st Place Evidence-Based Practice Category

Liis Teene, MSc; and Monique Y. Rennie, PhD

Introduction: More than $33 billion is spent annually on chronic wounds in the United States, leaving facilities and payers in search of key areas for cost reduction. A seminal article stated: “By questioning and justifying the need to sample and perform microbiological analyses on any problematic wound, long-term savings in cost, labor, and time to both the wound management team and the microbiology laboratory could be considerable.” This model assessed sampling-based cost savings from the incorporation of bacterial fluorescing imaging (FL; MolecuLight i:X; MolecuLight, Toronto, ON, Canada), which detects moderate-to-heavy bacterial loads in real time, into routine wound assessment. 

Assumptions: Model assumed an average sampling cost of $250, as reported from the Centers for Medicare & Medicaid Services physician-billed test payment. Cost increases would be incurred with the purchase of the device and use of an environment darkening drape in 40% of cases. 

Modeling: Ottolino-Perry et al described the incidence of sampling in 27 wounds based on CSS compared with FL guidance. Some 66.7% of wounds would have been sampled based on CSS, and 40.7% of wounds would have been sampled based on FL. The prevalence of moderate-to-heavy bacterial loads in those wounds was 44%. Extrapolating this to a typical wound care clinic with 2 clinicians seeing 25 patients per day over 3 clinic days per week, an estimation of the annual lab costs was calculated. 

Results: Fluorescence-informed sampling decisions in this extrapolated model would have eliminated 824 lab tests, resulting in a gross savings of $205 920. The net savings in the model were estimated to be $156 873, yielding a device “pay back period” of 2 months based on sampling cost reduction alone. 

Conclusions: Real-time information on the presence and location of fluorescence from bacteria at moderate-to-heavy loads can decrease wound sampling rates, resulting in substantial cost savings.

*1st Place Health Economics Category

Pedro Maldonado, BS

Introduction: The ability of negative pressure wound therapy (NPWT) to deliver targeted negative pressure (NP) is challenged by complexities in moving exudate and air from the wound to the therapy unit. Wound pressure-regulating technology (PRT) monitors wound pressure and adjusts system parameters to ensure set therapy is being administered and fluid is being removed. This regular, controlled system assessment evaluates the potential for exudate pooling by measuring delivered NP. 

Objective: Evaluate ability of 3 NPWT systems to maintain target pressure under various test conditions. 

Materials and Methods: Three PRT-based NPWT systems (NPWT-A [ActiV.A.C.; KCI, an Acelity Company, San Antonio, TX], NPWT-B [V.A.C.Ulta; KCI, an Acelity Company], NPWT-C [Cardinal Health NPWT; Cardinal Health, Waukegan, IL]) were tested (3 units x 3 dressings each). Tests were performed at clinically relevant target pressures (-75 mm Hg, -125 mm Hg), with the units at 36” above the dressing and with a fluid bolus (60 mL) and simulated exudate added to the system (43 mL/hour). Pressures at each condition were assessed for 1 hour. Standard statistical methods were utilized. 

Results/Discussion: Both NPWT-A and NPWT-B maintained average pressures within ± 10 mm Hg of the target pressure while NPWT-C did not. At a target pressure of -75 mm Hg, the average pressure maintained was -72.3 mm Hg for NPWT-A, -72.0 mm Hg for NPWT-B, and -60.1 mm Hg for NPWT-C. These average pressures proved to be significantly different when comparing NPWT-A with NPWT-C (P < .001) and NPWT-B with NPWT-C (P < .001). 

At a target pressure of -125 mm Hg, the average pressure maintained was -122.8 mm Hg for NPWT-A, -120.7 mm Hg for NPWT-B, and -107.0 mm Hg for NPWT-C. These average pressures proved to be significantly different when comparing NPWT-A with NPWT-C (P < .001) and NPWT-B with NPWT-C (P < .001). 

Conclusion: These PRT-based NPWT systems are not equivalent in performance. NPWT-A and NPWT-B systems consistently delivered prescribed therapy levels under challenging experimental conditions; NPWT-C systems were not capable of doing so.

*1st Place Laboratory Research Category

Elaine Song, MD, PhD, MBA; Catherine T. Milne, APRN, MSN, ANP/ACNS-BC, CWOCN-AP; Tiffany Hamm, BSN, RN, ACHRN, CWS; Jeff Mize, RRT, CHT, CWCA; Lauren Meyers, MBA; Kimberly Harris, RN, CWCA; Amy Smith, RN, JD; Samantha Kuplicki, MSN, APRN-CNS, ACNS-BC, CWS, CWCN-AP, RNFA, CFCN; Lydia Masako Ferreira, MD, PhD; and Alex Wong, MD, FACS

Background: Local dressing formularies reinforce the use of clinically appropriate and cost-effective products. Despite its significant potential to impact on the bottom line, many institutions postpone decisions to create a local formulary, as the process is frequently regarded as time-consuming. 

Once implemented, formularies are frequently saved as local files that need to be manually updated. The authors aimed to create a solution to overcome obstacles in formulary development, implementation, and management. 

Method: Using the Design Thinking methodology (WoundReference Clinical Decision Support Web-App; Wound Reference, Inc, San Francisco, CA), the solution was developed as a module within a clinical/reimbursement decision support web-application for wound care and hyperbaric clinicians, as follows: 

• Clinician needs/desired features were identified through interviews. 

• The module was developed with robust programming language, library, framework, and APIs. 

• The module was implemented at a hospital-based outpatient wound clinic. 

• Products used by the clinic were selected among ~1000 product profiles stored in the module. Selected products were automatically categorized and listed in groups (eg, alginates, foam). 

• Guided by the web application’s evidence-based content, interactive feature matrices, and virtual advisory panel, clinicians chose products with best fit, eliminating redundancy within each product group. 

• Clinic added custom instructions/educational notes to each product on the digital formulary, to serve as staff quick-reference manual. 

• Clinic shared link to formulary with partnering institutions (eg, home health agencies). 

Results: The module streamlined development of a local wound care formulary through automatic product categorization, immediate access to critical formulary decision-making information, product-specific customized notes, and real-time interdepartmental collaboration. The process resulted in a 36% decrease in the number of products (from 67 to 43 across 22 categories), and an inventory cost savings of 7% ($35 888/year). 

Conclusion: A solution to streamline creation of local wound care formularies was developed. Implementation resulted in inventory cost savings and increased staff efficiency. Its ease of use may significantly increase adoption of cost-effective formularies and maximize health outcomes.

*1st Place Practice Innovations Category