Evaluation of Effects of
Conformable Bovine Collagen on Diabetic Foot Wounds
Requiring Surgical Reconstruction
Scott Ellis, MD; Crystal V. James, MD; Munir Patel, MD; Emily Pesek, BS; Brooke Weiss, PA; Matthew Carpiniello, MD; and John C. Lantis II, MD
With diabetic foot ulcers (DFUs) being a major cause of morbidity and non-traumatic amputations, surgical management is often required. In this study, the authors used a conformable bovine collagen matrix to better conform to irregular wound bed surfaces. The objective of their study was to investigate the matrix’s ability to conform to an irregular wound bed on DFUs.
This single arm, open label, single institution, historic comparative quality assessment enrolled four patients with DFUs appropriate for debridement in the operating room (OR) as well as placement of cellular- and/or tissue-based products (CTPs) for the application of a flowable bovine collagen matrix in the OR. Patients underwent four weeks of follow-up visits. Reapplication of the matrix was performed in the clinic setting, if necessary. The primary endpoints of this study included treatment tolerance and lack of wound infection. Secondary endpoints consisted of percentage of wound closure at four weeks, compliance, and adverse events.
Wound sizes ranged from 0.3 cm2 to 2.7 cm2. Initial application of the matrix was performed in the OR after appropriate debridement; patients reported no issues with the application process. There were three patients who underwent reapplication in the clinic setting after one to three weeks. A total of five wounds were treated in the four patients; one patient received an application of the matrix to their postoperative transmetatarsal amputation wound. Average wound size decreased by 67.9%, with 40% of patients reaching full wound closure. The authors reported difficulty with applying and maintaining contact with the matrix to shallow wound beds. In addition, another downside the authors reported included the product adhering to the initial nonadherent petroleum-based secondary dressing; dressings were changed to a transparent film with success.
In summary, the authors found the average decrease of 67.9% over four weeks of follow-up, with two wounds (40%) achieving full wound closure. Although this was a limited study (ie, small sample size), this product shows promise in regard to deeper wound beds with good patient tolerance, no infections or adverse events reported, and a significant wound size decrease.
Challenges of a Wound Care Center: Compliance and COVID-19
Marcus S. Speyrer, RN, CWS, DAPWCA, and Kerry T. Thibodeaux, MD, FACS, CWSP, FAPWCA
The COVID-19 pandemic has impacted every person in the United States and the world, especially health care workers. The pandemic has left a lasting imprint, whether good or bad, that will stay with an individual for a lifetime. With such a profound effect on everyday life, care for patients with wounds has had to change and adapt.
In this poster, the authors address the roadblocks they have encountered in their practice this year as a result of COVID-19. The purpose of their poster was to report their protocol for utilizing hyperbaric oxygen therapy (HBOT) in patients with COVID-19. Additionally, the authors highlight their tactics of enhancing treatment compliance and improving communication between patient and clinician/staff member.
To address roadblocks and shortcomings, the staff at The Wound Treatment Center in Opelousas, LA, checked in with patients on a monthly basis and required all patients to re-register with updated health insurance as needed. They also noted that it was difficult to receive offloading and compression accessories due to the reduction of nonessential medical care; this roadblock was counteracted by coordinating with multiple vendors to schedule patient referrals as soon as possible. Like most hospitals and clinics, the authors’ institution ramped up its patient screening prior to allowing patients into the wound care center; some of these new protocols for their hospital included wearing personal protective equipment, implementing social distancing, increasing disinfectant methods/frequency, securing the corridor for patient and HBOT staff use only, improving air purification, transporting patients with HBOT gurneys, and providing supplemental oxygen, patient-worn surgical masks, and negative pressure hoods. To aid in this, the staff also improved the level of communication by confirming appointments and reviewing the hospital screening criteria with patients and home health agencies.
In terms of the HBOT protocol, it was developed with the 2 authors, hospitalists, and the critical care pulmonologist. The protocol included a detailed cleaning procedure for the HBOT chamber terminal, such as applying disinfectant inside the chamber, pressurizing the chamber to 3 ATA for 20 minutes followed by emergency venting of pressure, wiping down the interior chamber completely, and disinfecting the outside of the chamber surfaces during pressurization and the HBOT stretcher, mattress, and pillow. This protocol was the result of an increased case load at their wound care center due to the necessity of providing HBOT to patients with COVID-19 who were in respiratory distress. The authors and others have found that HBOT can reduce the need for mechanical ventilation, which is a treatment method available at the authors’ wound care center.
In summary, the authors’ wound care center worked to improve patient communication, obtain referrals, and create a protocol to safely administer HBOT to patients with COVID-19 who are experiencing respiratory distress.
Documentation of Patient Repositioning Events: Comparison of Electronic Medical Record Documentation and Accelerometer-based Wearable Sensors
Angelia Rose, MSN, RN, FNP-C, and Annemari Cooley, MBA, MA
Repositioning documentation serves an important function for pressure injury root cause analysis,1 pressure injury (PrI) prevention programs, and litigation defense.2 Although many data points such as vital signs and laboratory test results are automatically populated in the electronic medical record, patient repositioning is still documented manually and often at the end of the shift.
This study sought to understand differences in repositioning documentation using traditional manual methods versus automated documentation from accelerometer-based wearable sensors.
Repositioning documentation was analyzed retrospectively on a random convenience sample of 30 telemetry and surgical patients in February 2020 with every-2-hour turn protocols. Patients with preexisting pressure injury, body mass index < 14 kg/m2, expected stay > 48 hours, or those unable to turn themselves were assigned sensors that provided visual turn reminders and automatically documented all repositioning events. Staff members were exempt from documenting turns for patients with sensors but were required to manually document turns for all others.
Documentation was compared for patients with and without sensors. For the sensor group, documented positions ≥ 15 minutes were counted for each complete 12-hour shift. For the manual documentation group, repositioning events per complete shift were counted, including transfers from bed to chair and ambulation events.
In the sensor group, mean number of turns was 4.6 per shift (min 3, max 11). Mean time between turns was 2.6 hours. In the manual group, mean number of turns was 0.5 per shift (min 0, max 5). Five (5) patients had no turning documentation. Mean time between turns was 28.75 hours. New position/orientation was documented 100% in the sensor group and 0% in the manual group.
In this study, repositioning events were documented significantly more frequently by wearable sensors than manual methods. Sensor-based documentation may offer a more complete history of a patient’s mobility to assist in root cause analysis or when auditing patient care.
1. National Pressure Injury Advisory Panel. Root Cause Analysis Toolkit. 2020. https://npiap.com/page/RCAToolkit
2. Genesio J. Pressure ulcers are easy pickings for lawsuits. A long-term care center should regularly train and re-train staff on wound care, emphasizing the importance of documentation. Provider Long Term Care & Post-Acute Care. 2016;42(4):35–38.
Superabsorbent Dressing Impact on Fluorescing Bacteria in the Real-World Setting
Catherine T. Milne
Wound exudate contains bacteria, matrix metalloproteases, and other related biofilm material.1 The use of wound dressing technology to remove and sequester these materials is thought to improve wound outcomes. Although there is increased use of superabsorbent polymer (SAP) dressings to control exudate and reduce dressing changes, most bacterial sequestration data remain in vitro1,2 or focus on in vitro dressing failure and strikethrough as surrogates for bacterial contamination of the wound or patient environment.3 It is unclear if SAP dressings can demonstrate wound surface bacterial reduction or environmental sequestration in the real-world setting.
The purpose was to evaluate the impact of a superabsorbent dressing (KERRAMAX CARE Border Dressing; Systagenix Wound Management, Gatwick, UK) on bacterial sequestration by performing real-time visualization of bacterial fluorescence (BF) of the wound bed prior to and after removal of the SAP. Additionally, bacterial transfer to the environment via leakage or strikethrough was assessed via BF.
The SAP dressings were found to uptake and sequester exudate containing fluorescing bacteria with positive impacts on the wound bed in ten highly exudative wounds. The SAP did not demonstrate leakage or strikethrough that would indicate bacterial transfer returning to the wound, its surrounding skin or into the patient’s environment.
SAP dressings can improve the wound bed environment by impounding exudate, including fluorescing bacteria that can be impede wound improvement.
1. Westgate S, Cutting K. Using hydration response technology dressings in bacteria management. Wounds UK. 2012;8(3):68–73.
2. Lovett J, Jackson S, Stephenson C. A comparison of bacterial sequestration in two superabsorbent dressings. Poster presented at: Wounds UK Annual Conference; November 14-16, 2016; Harrogate, UK.
3. Browning P, White RJ, Rowell, T. Comparative evaluation of the functional properties of superabsorbent dressings and their effect on exudate management. J Wound Care. 2016;25(8):452–462. doi:10.12968/jowc.2016.25.8.452
Cleansing Chronic Lower Limb Wounds Using Negative Pressure Wound Therapy With Instillation and Dwelling of Normal Saline
Robert J. Klein
Chronic podiatric wounds are common sources of morbidity and mortality in elderly patients, requiring adequate removal of nonviable tissues paired with active management of the wound healing environment. Negative pressure wound therapy (NPWT) with the instillation and dwelling (NPWTi-d [V.A.C. VERAFLO Therapy; 3M + KCI, San Antonio, TX]) of cleansing topical solutions is a versatile tool for solubilizing slough and creating micro-deformations on the wound surface. In this case series, we report on the use of NPWTi-d for 3 chronic wounds in elderly patients with multiple comorbidities.
Patient 1 was a 65-year-old obese female with peripheral vascular disease, chronic venous insufficiency, hyperthyroidism, chronic obstructive pulmonary disease, fibromyalgia, and lymphedema, who had a dehisced wound on her right foot that was non-healing after 90 days. Patient 2 was a 78-year-old female with peripheral neuropathy, hypertension, and osteoarthritis, who presented with a 300-day neuropathic ulcer on her left foot. Patient 3 was a 75-year-old obese, diabetic male with coronary heart disease, peripheral vascular disease, stage 4 chronic kidney disease, hyperlipidemia, chronic obstructive pulmonary disease, gastroesophageal reflux disease, neuropathy, osteomyelitis, and a past myocardial infarction. He presented with a 210-day Wagner grade 3 diabetic foot ulcer of the right lateral malleolus. Each patient had undergone lower limb procedures within the past 2 years, and previous treatments included conventional NPWT, enzymatic debridement, and excisional debridement. NPWTi-d was initiated to wash the wounds with saline, soaking for 1 minute, followed by 3-hour cycles of continuous -125 mm Hg. After a period of 7 to 33 days, NPWTi-d was discontinued, and care was transitioned to advanced wound dressings.
All 3 wounds responded positively to therapy, exhibiting reduced slough, growing granulation tissue, and reducing in size. In these patients with chronic wounds, NPWTi-d was effective in creating an environment that promoted wound healing and prepared the wound for eventual closure.
Incision and Surrounding Soft Tissue Management of the Breast Using Closed Incision Negative Pressure Therapy With Full-Coverage Dressings
For patients undergoing breast surgery, incisional management can have a significant impact on healing outcomes and patient satisfaction. Closed incision negative pressure therapy (ciNPT) using a novel foam dressing that covers breast incisions, the nipple-areolar complex, and surrounding tissues (PREVENA RESTOR BELLAFORM Incision Management System; 3M + KCI, San Antonio, TX) creates a barrier against external contaminants, removes fluid and infectious materials, reduces edema, and bolsters the breast by holding the incisional edges together.
We report the outcomes of 7 patients undergoing breast surgery followed by ciNPT with full-coverage dressings. The patients comprised 1 male and 6 females aged 21 to 49 years old. Patient medical history included weight loss greater than 50 pounds, fibromyalgia, polycystic ovarian disease, endometriosis, and smoking. Body mass indices were 25.6 to 32.4 kg/m2. Surgery types included breast reduction (n = 3), breast augmentation (n = 2), implant exchange (n = 1), and bilateral mastectomy for male gynecomastia (n = 1). Incision lengths ranged from 23 to 40 (mean: 32.9) cm, and all were closed using buried subcuticular sutures. Patients received prophylactic antibiotics and ciNPT with full-coverage dressings at -125 mm Hg. Four patients were immediately discharged for outpatient care, 2 patients were discharged on postoperative day (POD) 1, and 1 patient was discharged on POD 2. On POD 7, ciNPT was discontinued, and all incisions remained closed.
Within the 30-day follow-up period, 1 patient experienced a minor dehiscence of the left breast and another patient developed a small seroma on POD 15, but there were no signs of infection and no intervention was required. Upon follow-up 3 to 5 months post-surgery, we observed an overall reduction in swelling, less pain, improved range of motion, and improved scar appearance. In this patient population, we report that ciNPT with full-coverage dressings provided support for incision healing after breast surgery by protecting the incisional environment and moving fluid away from the surgical site.
Effectiveness of Continuous Diffusion of Oxygen Adjunct Therapy to Improve Success Rate of Lower Extremity Surgically Closed Wounds – A Randomized Controlled Trial Study
Lower-extremity surgically closed wounds in patients with diabetes could be severely affected by poor tissue oxygenation.1,2 Adverse events (AE) such as necrosis, dehiscence, or re-operation are among the most common complications.3 In this study, we tested a continuous diffusion of oxygen (CDO) novel dressing as supplement to reduce the likelihood of AE.
Nineteen diabetic patients who underwent minor amputation requiring surgical wound closure were randomized to either control (CG: n = 7) or intervention (IG: n = 12) groups. The IG received CDO using a portable O2 delivery system (TransCu O2; EO2 Concepts, San Antonio, TX) for a 4-week period or until successful wound closure. The CG group received standard of care dressing for the same period. Primary outcomes were incident of AE and changes in wound length at 4 weeks. For those successfully healed wounds, percentage of wound reduction (%WR) was considered as 100%. For those with wound dehiscence, %WR was noted as 0%. For other cases, %WR was objectively measured using an imaging system (Snapshot NIR; KENT Imaging Inc., Calgary, AB, CAN). General linear model was used for analysis. The study was registered in Clinicaltrials.gov-Identifier: NCT03960463.
Three cases (43%) among CG had AE which required re-operation. Two IG cases (16.6%) reported saturated dressing and excessive bleeding which were excluded before completing the study. This led to modification in dressing to accommodate absorbing excessive saturation. No AE was reported for IG after dressing modification. At 4 weeks, the incision length reduction was 70% higher in IG compared to control. This trend did not achieve a statistically significant level in our sample (P = 0.059).
To our knowledge this is the first study reporting potential effectiveness of CDO to improve surgically closed wound outcomes. The results, while preliminary, support proof of concept feasibility, acceptability and noticeable trend in favor of CDO to accelerate healing in surgical closed wounds and reduce the likelihood of AE.
1. Chandan K, Sen, et al. Wound healing essentials: let there be oxygen. Wound Repair Regan. 2009; 17(1): 1-18.
2. Wernick B, et al. Impaired Wound Healing. StatPearls Publishing; 2020.
3. Zegers M. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies. Patient Sat Surg. 2011;5:13.
Soft Tissue Infection and Osteomyelitis Pathogens in Puncture Wound Injuries
David H. Truong
The purpose was to compare soft tissue infection (SSTI) and osteomyelitis (OM) pathogens in patients with and without diabetes and in patients who did and did not wear shoes at the time of puncture injuries.
We performed a retrospective review of 113 consecutive patients between June 2011 and March 2019 with foot infection from a puncture injury; 83 had diabetes (DM) and 30 did not (NDM). We evaluated the presence of skin and soft tissue infection (SSTI), presence of osteomyelitis (OM), and the pathogen in each. Osteomyelitis was diagnosis via confirmation on histopathology and/or positive microbiology result. All cultures were taken before the administration of antibiotics.
Patients with DM were 17.29 times more likely to develop osteomyelitis after puncture injury (CI, 0.01-0.45; P < .0005) and 4.31 times more likely to develop a SSTI (CI, 0.09-0.58; P = .001). When patients with DM developed a SSTI, it was 5.03 times more likely to be polymicrobial (69.6% vs. 31.3%; CI, 0.06-0.64; P < .005). The most common pathogen for SSTI and OM in DM was S aureus (50.7% and 32.3%), whereas in NDM it was Pseudomonas (25%) for SSTI and S epidermis (50%) and streptococcus (50%) for OM. There was no reported case of fungal or anaerobic OM pathogen in the NDM group, whereas in the DM group there was 9.7% anaerobic and 3.2% fungal infection.
This study showed that pathogens in puncture injuries have changed a great deal compared with 25 years ago. Pseudomonas in SSTI and OM were not as prevalent as it was thought to be in patients who wore shoes at the time of injury. The most common organism in both SSTI and OM was Staphylococcus. Furthermore, Pseudomonas was present in SSTI whether the patient did or did not wear shoes at the time of injury.
The Use of Point-of-Care Bacterial Autofluorescence Imaging in the Management of Diabetic Foot Ulcers: A Pilot Randomized Controlled Trial
Diabetic foot ulcers (DFU) have considerable morbidity and mortality, negatively impact patients’ quality of life, and are of significant cost to health services. Despite guideline recommended management, less than half of DFUs in the UK have healed by 12 weeks.1 Bacterial autofluorescence imaging (MolecuLight i:X; MolecuLight, Toronto, ON, Canada) has been shown to improve healing of chronic wounds in case series.2 We aim to investigate the clinical effectiveness and decision making associated with the use of bacterial autofluorescence imaging in the management of DFU.
This is a single centre, pilot randomized controlled trial (RCT) in patients with a DFU, with blinded outcome assessment. Patients were randomized in a 1:1 allocation ratio to either treatment as usual (TAU) informed by bacterial autofluorescence imaging, or TAU alone, stratified by ulcer location and vascular status. Trial visits occurred at week 0, 4, 8, and 12. The primary outcome is the proportion of ulcers healed at 12 weeks. Secondary outcomes include ulcer healing rate, patient quality of life, and change in management decisions following bacterial autofluorescence imaging.
Fifty-six (56) patients were randomized; 50 have completed follow-up, 4 were lost to follow-up, 1 withdrew from the trial, and 1 died due to unrelated cause.
Using a worst-case scenario ITT analysis, the proportion of ulcers healed with the use of bacterial autofluorescence imaging (n = 13, 45%) at 12 weeks was significantly higher than those with TAU alone (n = 5, 19%; P = 0.035). Further wound debridement was the most common intervention in those with positive imaging.
To our knowledge, in the first RCT assessing the use of autofluorescent imaging in the management of DFUs, we have shown it to be a valuable adjunct to standard care, guiding interventions with promising results in the treatment group. Further definitively powered studies can be based on these results.
1. National Diabetes Foot Care Audit Report 2014-2017. https://files.digital.nhs.uk/pdf/e/9/ndfa-3ar-rep.pdf
2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, et al. (2015) Point-of-Care Autofluorescence Imaging for Real-Time Sampling and Treatment Guidance of Bioburden in Chronic Wounds: First-in-Human Results. PLoS ONE10(2): e0116623