Examining the Clinical Outcomes of a Soft Silicone Multilayer Foam Dressing for Exudate Management in US Hospitals: It Is Time to Optimize Dressing Change Frequency

As of 2015, there were more than 3000 wound products available on the market,¹ separated into numerous categories to address a range of patient and clinician requirements. Dressings are designed to address the unique needs of wounds as they progress through the 4 stages of healing: hemostasis, inflammation, proliferation, and remodeling.¹ Clinicians select dressings based on the dressing’s ability to manage the characteristics of the wound being treated, such as moisture level, temperature, protection against bacterial infection, and adherence to the wound.^1,2 

Dressings in the SSMFD category are versatile and flexible in their capacity to address a range of factors clinicians must consider. Some dressings in this category are indicated for use in PI prevention when placed over an area of at-risk, intact skin,³ as well as for treatment and exudate management for a range of acute and chronic wound types.⁴ The specific SSMFD evaluated in the current study has been shown to be easy to use by clinicians and, because of the silicone adhesive and dressing conformity,^5-7 easy to apply and remove while offering substantially greater absorption than many leading competitors.^7,8 

Health care systems face consistent pressure to optimize their use of resources due to increasing demands to provide higher acuity care while challenged by deepening financial instability.⁸ The American Health Association reports that 60% of hospital expenses result from labor costs and 13% from supply costs.⁸ In practice, hospital protocols typically standardize the frequency of dressing change rather than rely on clinical judgment or manufacturer recommendation to determine this parameter. 

The SSMFD evaluated in the current study is indicated for a wear time of up to 7 days on open wounds. However, dressing wear time is dependent on wound characteristics, level of exudate, and frequency of reassessment by HCPs. An extended wear time can potentially offer the clinical benefit of enhanced wear time and reduced dressing change frequency when compared with standard occlusive dressings.^5,6 The proprietary dressing is designed to stay in place longer to facilitate undisturbed wound healing and has several unique features to support the reduction of unnecessary changes, including a visual change indicator. The unique change indicator of this SSMFD provides a clear visual guide of when the dressing should be changed.^5,9 The change indicator subtly demonstrates when the dressing is reaching maximum absorptive capacity, thus prompting the clinician or patient that a dressing change is due (Figure 1).

The legal manufacturer recommends that the dressing should be changed depending on the condition of the wound and surrounding skin and advises that the clinician consider changing the dressing when exudate covers 50% of the change indicator and to change the dressing once exudate reaches 75% of the change indicator. Theoretically, this can help minimize premature removal of the dressing and help extend the time between dressing changes.^5,9 In addition, this particular dressing contains an added layer designed to mask exudate, thus reducing the visual effect of strikethrough, while the top film layer provides a bacterial barrier.^7,10 While this can help patients feel more confident in the appearance of their dressing, it also provides a clear visual guide of when the dressing should be changed.^5,9 

Unnecessary, frequent dressing changes may create undesirable changes in the wound bed or may lead to a risk of complications¹¹ due to continued disruption and potential trauma to the wound bed and surrounding periwound area,^5,12 in addition to the more frequent risk of wound contamination from the external environment.¹⁰ Additionally, extending the time between dressing changes can lead to increased efficiency,⁷ reducing resource utilization in terms of both supply costs and staff time. 

Although the SSMFD evaluated in the current study is indicated for a wear time of up to 7 days if clinically appropriate, dressings are often changed more frequently, particularly in the hospital. This analysis used real-world data to evaluate SSMFD dressing change practices and clinical outcomes pertaining to wound type, size, exudate level, and wear time within hospital settings across the United States.

HCPs were recruited from a health care research panel (Sermo) accessed via a market research and analytics agency (The Nursery). The panel was screened for HCP candidate eligibility to ensure that they regularly treated the indicated open wound types in a US hospital setting with the specific SSMFD being examined (Allevyn Life; Smith and Nephew). The panel was composed of anonymous HCP participants. Six of the 18 participants chose not to report their institution, and 12 were identified and included from different institutions located throughout the United States. HCPs were eligible to complete online data collection provided they had used the specific SSMFD in the past 18 months to treat wounds managed in an acute hospital setting, covering any of the following wound types: PI, leg ulcers, DFUs, surgical wounds, superficial and partial-thickness burns, donor sites, skin tears, and fungating ulcers. The HCP participants were instructed to refer to patient medical records for data extraction. In alignment with local laws and regulations, no patient-identifiable data were disclosed. 

Following screening, the HCP participants provided responses via an online data collection portal. One retrospective data capture form was completed per wound treated, capturing patient medical history and wound-specific information. Ethics committee approval was not required, because all data captured and being reported were retrospective and fully de-identified. The retrospective data collection did not collect treating HCP names or contact details.

Data were collected from May 15, 2024, through May 21, 2024. The data collection form consisted of 6 sections, with questions pertaining to HCP and patient demographics, patient medical history, wound type and characteristics, treatment practices, wound outcomes when using the SSMFD, and the performance and safety of the SSMFD during wound treatment. The researchers were particularly interested in analyzing the responses pertaining to the wound types and characteristics that were selected for use of the SSMFD, dressing change frequency, and how often the change indicator was used to guide care. The data were reported as an aggregate using Microsoft Excel. Data were reported using descriptive statistics. 

HCP and patient demographics

Of the HCPs screened, 18 qualified to participate. Fifty-three individual retrospective data capture activities were completed, each representing a case in which the SSMFD was used in the past 18 months for management of wounds treated in an acute hospital setting. Ten of the HCP participants described themselves as physicians (56%), and 8 (44%) described themselves as nurses (Table 1).

The 53 patients whose cases were evaluated ranged in age from 15 to 93 years (mean age, 56.6 years). Most of the wounds examined occurred in male patients (n = 31 [58%]), and the most reported race or ethnicity was Black (n = 23 [43%]), followed by White (n = 22 [42%]). Race or ethnicity was collected as a part of routine demographics information and as stated in the medical record. Wound treatment occurred while patients were being cared for in medical-surgical (n = 35 [66%]), intensive care (n = 15 [28%]), and progressive care/stepdown (n = 15 [28%]) units (Table 2).

Patient medical history

At the time of treatment with the SSMFD, most patients were nonsmokers or former smokers (n = 31 [59%]), and 22 patients (42%) were current smokers (Table 2). The 3 most reported relevant comorbidities that may affect wound healing were hypertension (n = 41 [77%]), type 2 diabetes (n = 35 [66%]), and neuropathy (n = 29 [55%]) (Figure 2).

Wound type and characteristics

The most reported wound types were PI (n = 26 [49%]) and DFU (n = 11 [21%]) (Figure 3). The most common locations were the pelvis (ie, buttock, sacrum, or hip) (n = 24 [45%]) and foot (ie, ankle, forefoot, heel, or rear foot) (n = 16 [30%]). Most wounds had been present for less than or equal to 6 weeks at the time treatment with the SSMFD commenced (n = 36 [68%]).

Numerous interventions or treatments were reported as being applied to the wound or the surrounding skin before, during, and after use of the SSMFD, demonstrating the range of methods used by HCP participants when treating wounds in hospitals. The most reported treatments before, during, and after use of the SSMFD were absorbent pads, bandages, and gauze. Wound measurements obtained before commencing treatment with the SSMFD revealed the following mean wound dimensions: length of 5.32 cm and width of 4.70 cm. Of the 53 total reports, wound depth was recorded for only 36, with a mean depth of 1.83 cm (range, 1 cm–4 cm). The exudate level present at the start of treatment with the SSMFD was subjectively described as none (n = 6 [11%]), light (n = 30 [57%]), moderate (n = 15 [28%]), and heavy (n = 2 [4%]), with wounds most often containing a mixture of tissue types described as granulation tissue, epithelium, slough, necrotic black, and eschar (Table 3). 

Treatment and dressing change practices

The SSMFD was reportedly used for wound treatment for between 4 and 120 days (mean, 23.83 days). During this time, the SSMFD was changed on average every 2 to 3 days (n = 29 [55%]), daily (n = 14 [26%]), every 4 to 6 days (n = 6 [11%]), or once weekly (n = 4 [8%]). The change indicator was reportedly used in 52 of 53 cases (98%) to determine whether a dressing change was required. Most often, 2 lobes were filled when the change indicator was used to indicate that a dressing change was required (n = 23 [43%]), followed by 3 lobes (n = 18 [35%]) (Figure 1). Figure 4 details the number of lobes filled at the time of dressing change by wound type. This aligns with the instructions for use, which recommend considering a dressing change when 2 lobes are filled and changing the dressing when 3 lobes are filled. In the 1 case in which the change indicator was not used, the HCP noted that the wound exhibited “very low exudate and was often changed before the indicator was activated.”

Clinical outcomes

When asked about healing outcomes, the HCP participants reported the following: wounds improved (n = 37 [70%]), completely healed (n = 11 [21%]), or remained static (n = 5 [9%]). No wounds were reported as having deteriorated during treatment with the SSMFD. For the 37 cases reported as improved, the HCP participants were asked to specify what improved during treatment with the SSMFD. They were instructed to select all that applied and reported having observed a reduction in wound area (n = 30 [81%]), improved wound bed appearance (n = 29 [78%]), increased presence of granulation tissue (n = 23 [62%]), reduced clinical signs and symptoms of infection (n = 22 [59%]), reduced exudate levels (n = 19 [51%]), and improved periwound skin health (n = 19 [51%]). In 4 of 5 cases in which the wound reportedly remained static (80%), the clinical opinion of the HCP was that the outcome was not related to the SSMFD. When the 1 participant who indicated that they did believe this outcome was related to the SSMFD was asked to provide further information they stated, “This was a very deep broad wound that I never expected the patient to heal on their own. The [SSMFD] helped off load pressure and absorb exudate to bridge to surgical debridement.” For the 42 wounds that did not completely heal during management with the SSMFD, the mean length, width, and depth decreased by 36.93%, 37.2%, and 38.5%, respectively (Figure 5).

Performance and safety

When clinicians were asked to report on their assessment of the performance of the SSMFD as a wound management dressing through the patient’s treatment, all 53 (100%) reported that they were “satisfied overall.” Further detail on their satisfaction by individual components is provided in Figure 6.

Out of the 53 wounds examined, a complaint related to the use of the SSMFD was reported for 3. Table 4 details the 3 complaints reported, and the actions taken by the HCP. The product-related complaints were submitted to the SSMFD legal manufacturer complaints email address for assessment in alignment with US medical device complaint reporting criteria. 

The real-world data in the present study provide insights into the current approach to and practices concerning wounds managed with the proprietary SSMFD in US hospitals. In this data set, the average treatment time for wounds managed with the SSMFD was approximately 3.5 weeks, which is 5.4 times longer than the average 4.5-day length of stay for patients in US hospitals across all medical conditions.¹³ These data may demonstrate the increased morbidity among patients undergoing wound care in an acute setting. This will have an associated fiscal impact on wound treatment in hospitals. 

In the current study, when the SSMFD was used on wounds, it was most frequently changed every 2 to 3 days, with changes guided by the change indicator in 98% of wounds. Manufacturer recommendations suggest that a dressing change should be considered when 50% of the change indicator is saturated, which was most often the case in these data (n = 23 [43%]). However, in a round-the-clock hospital setting, consideration could be made for educating staff to extend the wear time, changing the dressing only after 75% of the change indicators are saturated to potentially reduce staff time and supply utilization. 

When specifically assessing the dressing change frequency by wound type in the current study, there was high variability in when the dressing was changed. The wound types PI and DFU were the most prevalent in the data set and also showed the highest variability in dressing change frequency. The HCPs were queried about the average number of lobes filled at dressing changes and the mean reported. Dressing changes occurred for PI when 1 to 4 lobes were activated and between 1 and 3 lobes for DFU. However, the highest number of mean dressing changes occurred when 2 lobes or 3 lobes of the SSMFD were filled, indicating a positive understanding of when to change the dressing. Compared with the other wound types, it was clear the dressing changes occurred much earlier in the change indicator activation, eg, when zero to 2 lobes were filled. What is most important about analyzing the mean number of change indictor lobes used to determine dressing change is the ability to make the clinicians aware that the SSMFD could have stayed in place longer. For example, in 22 patients (41%), 2 change indicator lobes were reported. In these patients, the dressing could have been left in situ provided there were no other clinical reasons necessitating more frequent assessment or wound treatment. Reducing the number of dressing changes may not only protect the wound from external contamination¹⁰ but also may promote undisturbed wound healing.^5,14 Ultimately, using the built-in technology of the SSMFD can drive appropriate dressing change protocols, lessen staff workload, enable longer dressing wear time, and reduce supply usage.

The analysis reported has limitations. This was not a controlled clinical study; instead, it was an analysis of routine real-world practice, using data extracted from patient medical notes and charts. The results detail a small sample of inpatient hospital wound care across multiple wound types and etiologies, with an objective to observe hospital-based wound management using the SSMFD. The findings are not designed to be generalizable; however, they do provide insight into dressing change behaviors in an acute setting. Future work is required with a larger patient sample, with an objective to control dressing changes in alignment with the SSMFD built-in change indicator, therefore allowing the assessment of undisturbed healing through improvements in exudate management, healing, and closure.

The current report did not assess for other potential reasons for dressing change beyond the exudate capacity of the dressing. Hospitalized patients exhibiting wounds in the acute phase, such as wounds resulting from trauma, surgery, or infection, may require more frequent assessment and/or alterations to the plan of care. In this data set, the most reported wound types were PI and DFU. The authors of the current study acknowledge that frequency of assessment would depend on whether the PI was acute, hospital-acquired, or chronic and already being treated prior to hospitalization. For DFU, frequency of assessment would depend on whether the wound was the cause of hospitalization (eg, infection or requiring surgical intervention) or a chronic wound receiving maintenance care in the postacute environment. Additionally, current hospital documentation requirements may call for reassessment and documentation of the wound more frequently than the dressing requires changing. In these cases, where repeated assessment of the wound is required, dressings with a silicone adhesive may provide a solution because they allow for lifting, assessing, and replacing the dressing, resulting in minimal disturbance to the wound, periwound, and surrounding skin. 

The SSMFD studied was shown to be an effective approach to wound management, with 21% of wounds fully healed and 70% showing improvement throughout the course of therapy. Nine percent of wounds remained static, and there were no reports of wound deterioration. The combination of the gentle silicone adhesive, dressing conformity, and the capacity to manage exudate work together to produce a versatile and effective dressing option for use in the acute hospital environment. The ability to use the SSMFD across a range of wound types and individual characteristics may support its use as a part of nurse-driven protocols, because it could provide ease of use and decision-making for bedside staff who are not expertly trained in wound care. In addition, the positive use of the change indicator shows that this built-in dressing technology is being used at the bedside and is influencing when dressing changes occur. This “reading” of the dressing can easily be built into a standard procedure for dressing change, thus enabling the change of dressing to be driven by a clinical decision rather than a set procedure, because ultimately, fewer dressing changes enables undisturbed healing. Through the provision of education to HCPs and necessary revisions to hospital policies and procedures, the use of dressing technology to inform best practice at dressing changes could become standard practice in the hospital setting.
 

Authors: Kelly McFee, DNP, FNP-C, CWS, CWCN-AP, NE-BC, FACCWS, MAPWCA¹; Mandy Spitzer, MBA, RN, CWOCN, CFCN²; and Julie Murdoch, PhD³

Affiliations: ¹Astria Health Wound Care and Hyperbaric Medicine, Sunnyside, WA, US; ²Global Clinical and Medical Affairs, Smith and Nephew, Fort Worth, TX, US; ³Global Clinical and Medical Affairs, Smith and Nephew, Watford, UK

ORCID: Murdoch, 0000-0002-9903-0925; Spitzer, 0000-0002-5192-5834

Disclosure: K.M. received a consultancy fee for her time participating in the development and writing of this manuscript and is a member of the speaker’s bureau for Smith and Nephew. M.S. and J.M. are employees of Smith and Nephew. Financial support was provided by Smith and Nephew.

Correspondence: Mandy Spitzer; Senior Clinical Strategy Manager, Smith and Nephew Inc, Global Clinical Medical Affairs, 5600 Clearfork Main Street, Fort Worth, TX 76109; amanda.spitzer@smith-nephew.com

Manuscript Accepted: August 16, 2024