1 INTRODUCTION

A hospital-acquired pressure injury is an adverse event, which needs systematic protective care.1 It has several names, for example, pressure sore or pressure ulcer. Deep pressure injury would result in pain and might influence the quality of life,2 causing increased hospital length of stay, and its related health care costs.3 Moreover, pressure injury is related to increased hospital death,4 or death within 30 days after hospital discharge.5 Therefore, skin integrity preservation is a standard of the quality of care delivered,6 with its prevention led by international prevention and treatment guidelines (National Pressure Ulcer Advisory Panel; European Pressure Ulcer Advisory Panel and Pan-Pacific Pressure Injury Alliance, 2014). Even though the effect of the term ‘pressure’ injury, friction and shear forces are also elaborated in producing skin injury.7 Therefore, preventive plans must focus on decreasing pressure, shear, and friction forces, and must comprise the use of specialised support surfaces, moving plans, prevention of friction when moving, and treatment of skin hydration.7

Current pressure injury preventative intrusion is the prophylactic use of a protective dressing, chiefly on the sacrum and heels. Protective dressing contains several layers of foam supplies. These dressings deliver an elastic, smoothing, and cushioning layer8 between the subject and the support surface to ease pressure injury-causative forces.9 Although standard cares are there to assess these dressings,8 the efficacy of protective sacral dressings is conflicting. Also, there is some argument about the extrapolation of confirmations from studies of one dressing type to another.8 However, in the clinical setting, these dressings are often used prophylactically for subjects at high risk of pressure injury, especially critically ill subjects,10 and are suggested for subject transport circumstances as a real notice to health care professionals about pressure injury inhibition.4 Numerous meta-analyses have examined the efficacy of prophylactically applied protective dressings.11-15 A 2013 Cochrane review of prophylactic use of soft silicone foam dressings showed a decrease in pressure injury frequency in numerous studies, with inadequate indication because of the low quality of the comprised studies.16 In an update to this meta-analysis, the indication was of very low and low graded for high risk of bias and high inaccuracy.17 Another meta-analysis18 showed no secure clinical indication for any type of protective dressing over another. These preceding meta-analyses have comprised studies with several designs and studies that examined dressings used to any site.19 This meta-analysis aimed to evaluate the effect of prophylactic sacral protective dressings on preventing pressure injury.

2 MATERIALS AND METHODS

The present study followed the meta-analysis of studies in the epidemiology statement,20 which was performed following an established protocol.

2.1 Study selection

The study parameters included statistical measures of association (odds ratio [OR], mean difference [MD], frequency rate ratio, or relative risk, with 95% confidence intervals [CIs]) between the effects of prophylactic sacral protective dressings on preventing pressure injury.

Only those human studies published in English were considered. Inclusion was not restricted by study size or type. Publications excluded were review articles, commentaries, and studies that did not supply a degree of relationship. Figure 1 shows the whole study process.

Schematic diagram of the study procedure

The articles were integrated into the meta-analysis when the following inclusion criteria were met: The study was a randomised control trial or a retrospective study. The target population includes community- or hospital-based adult subjects requiring care. The intervention programme was sacral protective dressings. The study included comparisons between the effects of sacral protective dressings compared with standard care with no sacral protective dressings. The exclusion criteria for the intervention groups were as follows: Studies that did not determine the effect of prophylactic sacral protective dressings on preventing pressure injury. Studies that included managements to prevent pressure injury in community- or hospital-based adult subjects requiring care other than sacral protective dressings. Studies that did not focus on the effect on comparative results. 2.2 Identification

A protocol of search strategies was prepared according to the PICOS principle,21 and we defined it as follow: P (population): subjects with community- or hospital-based adult subjects requiring care; I (intervention/exposure): sacral protective dressings; C (comparison): effects of sacral protective dressings compared with standard care with no sacral protective dressings; O (outcome): incidence of pressure injuries; and S (study design): no restriction.22 First, we conducted a systematic search of Embase, PubMed, Cochrane Library, OVID, and Google Scholar till July 2021, by using a blend of keywords and related words for sacral, protective dressing, pressure injury, prevention, as shown in Table 1. All detected studies were gathered in an EndNote file, duplicates were removed, and the title and abstracts were revised to eliminate studies that did not show any relationship between the effects of prophylactic sacral protective dressings on preventing pressure injury. The remaining studies were examined for related information.

TABLE 1. Search strategy for each database Database Search strategy Pubmed

#1 ‘sacral’[MeSH Terms] OR ‘protective dressing’[All Fields] OR ‘pressure injury’[All Fields]

#2 ‘prevention’[MeSH Terms] OR ‘sacral’[All Fields]

#3 #1 AND #2

Embase

‘sacral’/exp OR ‘protective dressing’/exp OR ‘pressure injury’/exp

#2 ‘prevention’/exp OR ‘sacral’/exp

#3 #1 AND #2

Cochrane library

#1 (sacral):ti,ab,kw OR (protective dressing):ti,ab,kw OR (pressure injury):ti,ab,kw (Word variations have been searched)

#2 (prevention):ti,ab,kw (Word variations have been searched)

#3 #1 AND #2

2.3 Screening

Data were abridged onto a standardised form on the following basis: study-related and subject-related characteristics as follows: last name of the primary author, period of study, year of publication, country, region of the studies, and study design; population type, the total number of subjects, demographic data and clinical and treatment characteristics; categories, qualitative and quantitative method of evaluation, information source, and outcome evaluation; and statistical analysis.23 If a study qualified for inclusion based upon the aforementioned principles, data were extracted independently by two authors. In case of disagreement, the corresponding author provided a final opinion. When the data from a particular study differed based on the assessment of the relationship between the effects of prophylactic sacral protective dressings on preventing pressure injury, we extracted the data separately. There is a risk of bias in these studies; therefore, individual studies were evaluated using two authors who independently assessed the methodological quality of the selected studies. The ‘risk of bias tool’ from the RoB 2: A revised Cochrane risk-of-bias tool for randomised trials was used to evaluate methodological quality.24 In terms of the evaluation criteria, each study was evaluated and allocated to one of the next three risks of bias-low: if all quality criteria were met, the study was considered to have a low risk of bias; unclear: if one or more of the quality criteria were partially met or unclear, the study was considered to have a moderate risk of bias; or high: if one or more of the criteria were not met, or not included, the study was considered to have a high risk of bias. Any discrepancies were addressed by a reassessment of the original article.

2.4 Eligibility

The main result concentrated on the effectiveness of prophylactic sacral protective dressings in preventing pressure injury. An assessment of these aforementioned effects was summarised.

2.5 Inclusion

Sensitivity analyses were limited to studies reporting the relationship between the effects of prophylactic sacral protective dressings on preventing pressure injury. For sub-category and sensitivity analysis, we compared the sacral protective dressings compared with standard care with no sacral protective dressings.

2.6 Statistical analysis

We calculated the OR and 95% confidence interval (CI) using the dichotomous method with a random or fixed-effect model. We calculated the I2 index, and the I2 index ranged from 0% to 100%. When the I2 index was approximately 0%, 25%, 50%, and 75%, it specifies no, low, moderate, and high heterogeneity, respectively.21 If the I2 was >50%, we used the random-effect; if it was <50%, we used the fixed-effect. We stratified the original assessment as per result categories as described previously to complete the subgroup analysis. Differences among the sub-categories were considered statistically significant at a P value <.05. Publication bias was assessed quantitatively using the Egger regression test (publication bias is present if P ≥ .05), and qualitatively, by visual inspection of funnel plots of the logarithm of odds ratios vs their standard errors.23 All the P values were calculated via two-tailed tests. Reviewer manager version 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) was used to do all calculations and graphs.

3 RESULTS

A total of 967 unique studies were identified, of which 11 studies (between 2015 and 2021) fulfilled the inclusion criteria and were included in this meta-analysis.25-35 The 11 studies included 5150 community- or hospital-based adult subjects requiring care at the start of the study; 2832 of them were using sacral protective dressings and 2318 were given standard care with no sacral protective dressings. All studies evaluated the effects of prophylactic sacral protective dressings on preventing pressure injury.

The study size ranged from 68 to 1605 community- or hospital-based adult subjects requiring care at the start of the study. The details of the 11 studies are shown in Table 2.

TABLE 2. Characteristics of the selected studies for the meta-analysis Study Country Total Sacral protective dressing No sacral protective dressing Santamaria25 Australia 440 219 221 Kalowes26 United States 366 184 182 Aloweni27 Singapore 331 129 202 Forni28 Italy 359 177 182 Santamaria29 Australia 305 150 155 Lee30 Korea 71 36 35 Gazineo31 Italy 68 34 34 Serrano32 United States 915 477 438 Baghdadi33 Iran 90 60 30 Oe34 Japan 600 300 300 Beeckman35 Belgium 1605 1066 539 Total 5150 2832 2318

Sacral protective dressings had a significantly lower incidence of pressure injuries (OR, 0.39; 95% CI, 0.28-0.53, P < .001) with low heterogeneity (I2 = 48%) compared with standard care with no sacral protective dressings in community- or hospital-based adult subjects requiring care, as shown in Figure 2.

Forest plot of the effect of prophylactic sacral protective dressings on preventing pressure injury

Selected studies stratified analysis adjusts for age, gender, and ethnicity were not performed, because no studies reported or adjusted for these factors. Based on the visual inspection of the funnel plot as well as on quantitative measurement using the Egger regression test, there was no evidence of publication bias (P = .88). However, most of the included studies were assessed to be of low methodological quality because of their small sample size. All studies did not have selective reporting bias, and no articles had incomplete outcome data and selective reporting.

4 DISCUSSION

This meta-analysis study based on the 11 studies included 5150 community- or hospital-based adult subjects requiring care at the start of the study; 2832 of them were using sacral protective dressings and 2318 were given standard care with no sacral protective dressings.25-35 Sacral protective dressings had a significantly lower incidence of pressure injuries compared with standard care with no sacral protective dressings in community- or hospital-based adult subjects requiring care.25-35 However, the analysis of results should be performed with carefulness because of the small number of some of the included studies (three studies ≤100 subjects) in the meta-analysis; recommending the requirement for more studies to confirm these findings or probably to significantly affects the confidence in the effect assessment.

Our meta-analysis aim was to systematically gather the available studies' evidence and evaluate the possible efficiency of prophylactic sacral protective dressings in preventing pressure injury.

This recommends that prophylactic use of a sacral dressing can decrease pressure injury frequency, which could be of clinical relevance. However, a factor that can influence the effect of the sacral dressing is the standard care given, and adherence to it. A prophylactically used protective dressing is only an intervention that might decrease pressure injury in the clinical setting and must be considered to be part of a management plan of pressure injury preventative care that is set and applied differently to each subject based on the evaluation of his pressure injury risk level.36 Additional studies are required to decide which risk groups will benefit more from the prophylactic dressing.25-27 An additional finding by Forni et al was that the protective sacral dressing postponed the progress of pressure injury, with pressure injury onset witnessed on the fourth day of admission in the standard care with no sacral protective dressings and the sixth day in the sacral protective dressings group.28 However, there is still an inadequate existing indication to specify the advantage of sacral protective dressings over standard care with no sacral protective dressings, and additional studies are required. Although some new studies in intensive care units showed no significant difference in the frequency of sacral pressure injury,32, 37 and another study showed the superiority of standard care with no sacral protective dressings in reducing the pressure injury, although the sample size was small.31 Carefulness is required before endorsing clinical use of a specific dressing as there has been disagreement concerning the extrapolation of indication from one dressing to another.8 Numerous studies were led with intensive care subjects.25, 26, 30 Intensive care unit subjects have a high frequency of pressure injury higher than other hospitalised subjects,38, 39 routine use of these dressings would have an important clinical influence. Although the cost related to treating pressure injury and, in some countries, institutionally-incurred financial punishments might validate the cost of buying and using sacral dressings for all intensive care subjects. Cost-effectiveness is a vital feature when defining the clinical importance of preventative sacral dressings. The net cost of the sacral dressings was shown to be lower than that of pressure injury management costs.40 In another Australian study, in a hospital setting,10 the cost-effectiveness of using a prophylactic dressing was assessed, to be of around 55% yearly saving.

This meta-analysis showed the relationship between the effects of prophylactic sacral protective dressings on preventing pressure injury. However, further studies are needed to validate these potential associations. Also, further studies are needed to deliver a clinically meaningful difference in the results. This was suggested in other meta-analyses, which showed a similar effect of prophylactic sacral protective dressings on preventing pressure injury.11-15 This requires further investigation and explanation because no clear rationale was found to explain these results. Well-designed studies are also needed to assess the factors including the combination of different ages, gender, and ethnicity, because our meta-analysis study could not answer whether these factors are associated with the results.

In summary, sacral protective dressings had a significantly lower incidence of pressure injuries compared with standard care with no sacral protective dressings in community- or hospital-based adult subjects requiring care. Further studies are required to validate these findings.

4.1 Limitations

There may be a selection bias in this study because so many of the studies found were excluded from the meta-analysis. However, the studies excluded did not satisfy the inclusion criteria of our meta-analysis. Moreover, we could not determine if the results were associated with age, gender, and ethnicity or not. The study designed to evaluate the association between the effects of prophylactic sacral protective dressings on preventing pressure injury was based on data from previous studies, which might cause bias induced by incomplete details. The meta-analysis was based on 11 studies with some studies with a low sample size (three studies ≤100 subjects). Factors including the age, gender, compliance, ethnicity, and nutritional condition of subjects were also possible bias-inducing factors. Some unpublished studies and missing data may cause a bias in the pooled effect. Subjects were using different main pharmacological medicines, different management schedules, dosages, and health care systems.

5 CONCLUSIONS

Sacral protective dressings had a significantly lower incidence of pressure injuries compared with standard care with no sacral protective dressings in community- or hospital-based adult subjects requiring care. Further studies are needed to confirm these findings. However, the analysis of results should be done with carefulness because of the small number of some of the included studies in the meta-analysis, recommending the requirement for more studies to confirm these findings or probably to significantly affect the confidence in the effect assessment.

CONFLICT OF INTEREST

The authors have no conflicts of interest to declare.

The datasets examined during the present study are obtainable from the corresponding author on reasonable request.

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