Topical Products for the Protection of Periwound Skin: A Scoping Review

Introduction. The periwound skin influences the evolution of the wound. Among the mechanisms that affect it are the wound’s own exudate and the use of therapeutic support devices. Objective. The objective of this scoping review is to map out topical products that have been implemented and evaluated for either the protection or treatment of injuries caused by exudate or the use of adhesives or therapeutic dressings on the periwound skin of acute or chronic wounds. Methods. The methodology for scoping reviews proposed by the Joanna Briggs Institute was adopted, and a 3-step search strategy was carried out. The first search was limited to MEDLINE and CINAHL. Subsequently, a search was conducted with the identified key words and the terms of the index for the selected databases. Finally, additional studies were sought in the references of all identified publications. Two reviewers conducted the searches independently. Literature in the English, Spanish, and Portuguese languages was included. Results. A total of 1229 studies were identified, 12 of which met the inclusion criteria defined for this review. From the included studies, 12 products were identified for wounds of different etiologies, with the most frequent being the alcohol-free barrier film and zinc oxide. Conclusions. To date, the level of evidence is low. It is necessary to develop more robust research that improves the quality of the literature available for treating people with wounds.

The periwound area has been defined as the area of skin extending to 4 cm beyond the wound (ie, the surrounding skin extending from the wound bed).¹ Patients with wounds, irrespective of their etiology, have the propensity for developing vulnerable periwound skin that may be associated with disease processes or their treatment regimens.² 

Periwound skin damage is not well documented,³ and the exact prevalence and economic implications of periwound skin damage is not currently available.³ Nevertheless, the impact of periwound skin damage is substantial³ as it can exacerbate pain, increase wound size, delay healing, and reduce a patient’s quality of life.⁴ Frequent problems in the periwound area include maceration, excoriation, dry (fragile) skin, hyperkeratosis, callus, and eczema.⁵

There are different commercial skin protectors designed to provide a barrier between the skin and any potential irritants, preventing wound fluid from coming into contact with the skin.⁶ Various skin barrier preparations are available, including ointments, creams, and barrier films that leave a protective film on the skin’s surface.

Although specific studies^7,8 have been conducted to evaluate the effects of topical products for the protection of periwound skin, these studies have not been comprehensively reviewed. Consequently, the outcomes of the application of these products on periwound skin of acute and chronic wounds remain unclear.

A preliminary search for existing reviews on the topic was conducted in the Joanna Briggs Institute (JBI) Database of Systematic Reviews and Implementation Reports, the Cochrane Database of Systematic Reviews, and PubMed. From this search, a systematic review⁹ and a recently published scoping review³ were identified. Despite having similar themes of reviewing periwound skin, the present proposed scoping review differs from the aforementioned reviews regarding its objectives and scope of the literature research. First, whereas the systematic review aimed to establish the cost-effectiveness of the alcohol-free barrier film (Cavilon; 3M) in the protection of the periwound skin of chronic ulcers,⁹ the scoping review identified and provided a narrative integration of the existing evidence related to the management and prevention of moisture-associated skin damage.³ This present scoping review aimed to identify the breadth of literature that focuses on the topical products applied exclusively on the periwound skin in acute or chronic wounds. Secondly, the current scoping review included scientific literature published in languages other than English. 

Thus, this study aimed to map topical products applied exclusively on periwound skin that have been implemented and evaluated for the protection or treatment of lesions caused by exudate or the use of therapeutic dressings or adhesives on the periwound skin in acute or chronic wounds. The following research questions guided the present review: Which topical products applied exclusively on the periwound skin have been implemented and evaluated for the protection or treatment of injuries caused by exudate or the use of therapeutic dressings or adhesives on the periwound skin of acute or chronic wounds? What outcomes have been reported in studies that have implemented and evaluated topical products for the protection or treatment of periwound skin in acute or chronic wounds?

This scoping review adopted the methodology of JBI scoping reviews as described in the JBI Reviewer’s Manual.^10,11 

Inclusion criteria
This scoping review considered all studies featuring adults (> 18 years old), independent of sex or race, with acute (eg, traumatic, burns, complicated, surgical) or chronic wounds (eg, venous or arterial ulcers, diabetic neuropathy ulcers, pressure ulcers). 

Concept. Research papers that reported the application of topical products on the periwound skin for the protection or treatment of lesions (maceration, excoriation, erythema, among others) caused by the exudate or use of therapeutic dressings or adhesives were considered. 

Context. Studies conducted in the hospital or ambulatory or community settings were considered, with no restriction placed on the geographical location or culture. 

Types of studies. All available literature from quantitative and qualitative primary studies were considered. Quantitative studies included experimental studies (randomized controlled trials [RCTs], non-RCTs, and other quasi-experimental studies including before-and-after studies) and observational designs (descriptive studies, cohort studies, cross-sectional studies, case studies, and case series studies). With respect to qualitative studies, phenomenological designs, great theory, ethnography, among others, were considered.

Search strategy
A 3-step search strategy was used in order to identify publications and gray literature for this review. An initial search limited to MEDLINE and CINAHL was undertaken, followed by an analysis of the text words contained in titles and abstracts and of the index terms used to describe the articles. A second search using all identified key words and index terms then was undertaken across all included databases. The third search included a search of all reference lists of the identified publications for additional studies. Studies published in the English, Spanish, and Portuguese languages were included. In addition, the authors of the primary studies were contacted for clarification or missing information when necessary. There were no date restrictions.

The search was performed between September 2018 and January 2019, in the following databases: PubMed (Portal), CINAHL, EMBASE, BVS, Scielo, Ovid (MEDLINE), Cochrane, EBSCO, ProQuest, ScienceDirect (Elsevier), Web of Science, Scopus, and Springer. Search for gray literature included Google Académico, Catálogo de Teses e Dissertaçoes (Capes), Tesis Doc- torales en Red, DART-Europe, and Teseo. 

Study selection
After the searches, all articles, theses, and dissertations were imported into Zotero,¹² a reference manager, where duplicates were removed. Two reviewers independently examined the relevance of the articles and gray literature based on the information provided in the title and abstract for the review. All complete articles, theses, and dissertations were retrieved for the studies that met the inclusion criteria. All discrepancies between the 2 reviewers were resolved through discussion based on the objectives of the review or with a third independent reviewer.

Extraction of results
Data were extracted from studies included in the scoping review by 2 reviewers independently using a charting table developed as recommended by JBI methodology for scoping reviews. 

After the duplicates were removed, 1229 records were identified for study selection. Based on the titles and abstracts alone, 20 studies met the inclusion criteria. The full-text articles were then obtained. Full-text articles were read, and 12 articles met the inclusion criteria (the reasons for exclusion of full-text articles are presented in the Supplementary File online). The Figure shows the study selection process.

Country and publication year
There were 6 studies^7,8,13-16 conducted in Spain and 2 studies^17,18 in the UK included in this scoping review. Included studies were published between 1994 and 2018. Table 1 shows the year of publication for the studies included.^7,8,13-22

Study design
Four studies^16,17,21,22 used an experimental design, 2 used a quasi-experimental design,^7,18 and 6 used an observational-descriptive design.^{8,13-15,19,20}Table 1 shows the studies included in this scoping review by study design.^7,8,13-22

Study population
The population size for the included studies ranged from 2 participants¹⁴ to 227 participants.²² The types of participants included adults with diabetic foot ulcers,¹⁵ pressure ulcers,^8,14,19 venous ulcers,^{13,16,17,19,20,22} and other, nonspecified ulcers. Table 2A, 2B, and 2C shows the type of wounds evaluated in the studies.^7,8,13-22

Topical products
The 12 included studies implemented and evaluated 12 topical products for the protection or treatment of injuries in periwound skin. These included the following: alcohol-free barrier film (Cavilon; 3M),^{8,13-18,20,22} Sorbaderm Barrier Cream (Aspen Surgical),¹⁸ zinc oxide ointment,^8,13,20 petrolatum product,²⁰ hyperoxygenated fatty acids in emulsion preparation skin care,⁷ modified collagen with glycerin,¹⁹ sulphated water to 1:1000,¹³ aqueous eosin 2%,¹³ hyperoxygenated fatty acids,¹³ hydrocortisone 1%,¹³ siloxane-based product,²¹ and alcohol-based skin protection (acrylate polymer in an isopropyl base; SKIN-PREP; Smith+Nephew).²¹

Outcomes measured
The outcomes measured in the 12 studies were divided into 3 categories: (1) efficacy/effectiveness, (2) product attributes, and (3) cost. At the same time, the outcomes measured in the efficacy/effectiveness category were classified in related measure with the wound and periwound skin. A full description of the outcomes is presented in Table 2A, 2B, and 2C.^7,8,13-22

Outcomes of efficacy/effectiveness: wound. Changes in wound size were assessed in 4 studies,^14,16,17,20 as well as assessment of exudate level.^{13,15,17,18,20} The median time (in weeks) to complete wound healing was measured in 1 study¹⁹ as well the mean healing rate in another study.¹⁷

Outcomes of efficacy/effectiveness: periwound skin. Erythema was assessed in 4 studies.^7,14,21,22 In 2 studies, edema,^7,14 maceration,^7,15 pain,^7,21 and the intensity of redness^14,21 were assessed. Signs of skin color, flaking, and itching were evaluated in 1 study⁷ as well as signs of skin erosion²¹ and inflammation.¹⁴ Other periwound-related outcomes included visible improvement to the skin,¹⁸ histological characteristics of perilesional skin,¹⁴ water-holding capacity,²² fat content,²² and stinging.^7,18

Regarding the scales, 2 studies used the Fedpalla scale,^7,13 which measures the deterioration of skin integrity in the perilesional skin in 5° and the prognosis of epithelialization, giving a score ranging from 5 to 25, with the range of 21 to 25 being of better epithelialization prognosis. One study¹⁷ used a periulcer skin assessment form to determine the condition of the periwound skin. The assessment measured and scored the appearance and/or extent of skin affected as well as the intensity of any erythema, maceration, eczema, irritation, dryness, weeping, and blistering within the defined area.¹⁷ The sum of the individual scores for each of the periulcer skin conditions was obtained, giving a total score range of 0 (none) to 28. Another study²⁰ used a score that assessed for the presence of erythema, the intensity of the redness, and any signs of skin erosion. A relative score was defined and evaluated between 0 and 3 depending on the severity of these parameters.²⁰ 

Outcomes related to product attributes. There was a total of 3 studies^7,17,21 that assessed comfort and application time, 2 studies^17,20 that assessed removal time, and 2 studies^7,18 that evaluated compatibilities with other prevention or treatment measures. Only 1 study¹⁸ assessed the ease of use, and 2 studies^18,21 assessed quick drying. One study²¹ assessed visibility on the skin, in addition to the possibility of staining and adhesion after application. 

Outcomes of cost. Only 1 study¹⁷ assessed the cost of nursing time and total cost.

The purpose of this scoping review was to examine and map topical products for the protection or treatment of lesions caused by the exudate or use of therapeutic dressings or adhesive on the periwound skin in acute or chronic wounds. To address this question, 12 primary studies published over a 24-year period were reviewed. It must be emphasized that testing this type of product has been of special interest in Spain and the United Kingdom. Even though the studies mentioned the study design, in 9 studies, the authors of this review had to confirm the design based in the literature. 

Most of the studies assessed an alcohol-free barrier film.^{8,13-18,20,22} However, no high level of evidence indicating significant positive results of alcohol-free barrier film versus other products, such as zinc oxide ointment, for protecting periwound skin have been described so far. In 1 study,²² the alcohol-free barrier film had a significant impact on the reduction of erythema on periwound skin compared with the placebo (water). This finding is consistent with a systematic review and meta-analysis⁹ in which the authors concluded the alcohol-free barrier film is a safe and effective skin barrier to protect the periwound area of chronic ulcers. Nevertheless, this conclusion should be interpreted with caution because the present results highlighted a lack of methodological rigor in the selected studies. In addition, 2 of the 3 authors were employed by the manufacturer (3M) and some of the studies included in the meta-analysis⁹ were supported by educational grants from the manufacturer. These aspects could bias the findings reported by the authors.⁹ Elsewhere, in this scoping review, studies with other products, such as hyperoxygenated fatty acids in emulsion, showed promising results. 

Different outcomes were measured in the 12 studies. To understand the outcomes of the studies included in this review, the authors classified them into 3 main categories. It is noteworthy that in some studies the exudate level^{13,15,17,18,20} was considered a direct outcome of efficacy/effectiveness, even though the topical product was not applied to the wound where the exudate was produced. The exudate can be controlled by selecting the most appropriate bandaging system and absorptive dressings from among hydrocellular dressings, hydrofibers, calcium alginates, hydrocolloids, hydrogels, and hydropolymers.²³

Since the objective of this scoping review was to examine and map the literature, this review did not assess the quality of the studies included and, therefore, recommendations for practice cannot be graded. Additional limitations are related to study designs (the authors only identified 4 RCTs^16,17,21,22), smaller sample sizes, short data collection periods, and lack of assessment for the long-term impact of the products. Only 3 studies^7,13,19 used an instrument for grading or assessing the condition of the periwound skin. 

Moreover, a major gap in the reviewed literature was the lack of information on the frequency of application of the products. This aspect limits the analysis and mapping of the characteristics of the topical products described in the included studies.

However, there were several strengths to this scoping review, the first of which is the systematic process undertaken to search, select, and review available studies. The second is the inclusion of various research designs to properly map the existing topical products. A limitation of this scoping review was the fact that only studies published in the English, Portuguese, and Spanish languages were included. Articles published in other languages also could have been important to this review.

As implications for future research, the authors of the present study believe the following are necessary: future primary studies should clearly identify characteristics of the intervention (application of topical products), type of study, context, and patient diagnosis. Further research needs to be undertaken to evaluate the effectiveness of different topical products in the protection of periwound skin in acute or chronic wounds, preferably using an RCT design to control internal and external threats to the validity of the study.

This scoping review provides the state of the current available evidence about topical products for the protection of periwound skin in acute or chronic wounds. Due to heterogeneity, the results must be considered only as descriptive. To date, the level of evidence is low, and further good, quality research is clearly needed to improve the quality of the literature available for people with wounds as well as wound care clinicians.

Authors: Giovanny Andrés Perez Jaimes, BSN; Wilmer Julián Rueda Barrera, SN; and Leidy Johanna Rueda Díaz, PhD

Affiliation: Escuela de Enfermería de la Universidad Industrial de Santander, Bucaramanga, Colombia 

Correspondence: Leidy Johanna Rueda Díaz, PhD, Professor, Escuela de Enfermería de la Universidad Industrial de Santander, Grupo de investigación CIMBIOS, Santander, Colombia; ljruedad@uis.edu.co

Disclosure: The authors disclose no financial or other conflicts of interest.