The efficacy of sacral foam dressing in preventing sacral pressure injury: A systematic review and meta‐analysis

Abstract

Purpose

We aim to evaluate the efficacy of sacral foam dressings in preventing sacral pressure injury.

Methods

The PubMed, Embase and Web of Science databases were searched for relevant publications until October 2023. All studies evaluating the efficacy of sacral foam dressings in preventing sacral pressure injury were included. We calculated pooled risk ratio (RR) with 95% confidence intervals (CIs) for binary outcomes. The Cochrane's Risk of Bias Tool were used to evaluate the quality of studies.

Results

A total of 9 randomized controlled studies with 3972 patients were included in this analysis. Sacral pressure injury rate was significantly lower in the sacral foam dressing group compared with the standard care group (RR: 0.37, 95% CI: 0.17–0.82). Furthermore, the rate of ≥stage II sacral pressure injury was also significantly reduced (RR: 0.56, 95% CI: 0.37–0.83), along with a lower blanching erythema rate (RR: 0.64, 95% CI: 0.42–0.97). No obvious publication bias was observed in the funnel plot (Egger's p values = 0.91).

Conclusions

Sacral foam dressing significantly reduced the incidence of sacral pressure injuries, including those of stage II or higher, and blanching erythema when compared to standard care without sacral foam dressing. However, the results should be interpreted with cautious because of the observed heterogeneity and the diverse patient population. Further larger, well‐designed randomized control studies are needed.

1. INTRODUCTION

Pressure injury (PI) is a prevalent concern in healthcare settings, often culminating in severe discomfort, longer hospital stays and escalated healthcare costs. ¹ , ² , ³ Among these injuries, sacral pressure injury (SPI) is particularly common due to the anatomical structure of the sacral area, which is prone to prolonged pressure and shear forces. ⁴ , ⁵ The prevention of such injuries is paramount as they can lead to serious complications such as infection, sepsis and, in severe cases, mortality. ⁶

Conventional standard healthcare measures like repositioning, mobilization and the utilization of support surfaces have been employed to mitigate the risk of pressure injuries. ⁶ However, these interventions have their limitations. For instance, they require significant nursing time and may not be feasible for all patients due to their medical condition or level of comfort. ⁷ Therefore, exploring alternative preventative strategies is necessary.

In this circumstance, the utilization of sacral foam dressings has emerged as a promising intervention for preventing SPI. ⁸ , ⁹ , ¹⁰ These dressings, designed to redistribute pressure and mitigate shear, have shown potential in reducing the incidence of SPI. Nonetheless, the discourse around the superiority of sacral foam dressings is accompanied by a degree of controversy. ¹¹ , ¹²

Previous meta‐analyses on this topic have encompassed studies of different designs, ¹³ including retrospective studies, and have examined various types of dressings applied to different body sites. ¹⁴ These analyses, while informative, lack the specificity required to conclusively determine the effectiveness of sacral foam dressings in preventing SPI.

The aim of this meta‐analysis is to evaluate the efficacy of sacral foam dressings in preventing SPI.

2. MATERIALS AND METHODS

The meta‐analysis was carried out according to the Preferred Reporting Items for a Systematic Review and Meta‐analysis (PRISMA) 2020 guidelines. ¹⁵

2.1. Search strategy

The PubMed, Embase and Web of Science databases were searched to identify all relevant publications until October 2023. The keywords used for the search were (‘Pressure Ulcer’ [Mesh] OR ‘pressure ulcer*’[Title/Abstract] OR ‘Bedsore’[Title/Abstract] OR ‘Pressure Sore’[Title/Abstract] OR ‘Decubitus Ulcer’[Title/Abstract]) AND (‘Foam’[Title/Abstract]) AND (‘Randomized Controlled Trials as Topic’[Mesh] OR ‘randomized controlled trial’[Publication Type] OR ‘random*’[Title/Abstract] OR ‘placebo’[Title/Abstract]). The detail search strategy was shown in Table 1. In addition, the reference lists of the selected papers were manually searched to retrieve additional relevant articles.

TABLE 1.

Search strategy in PubMed, Embase and Web of Science databases.

Database	Search strategy
PubMed (159)	(‘Pressure Ulcer’ [Mesh] OR ‘pressure ulcer*’[Title/Abstract] OR ‘Bedsore’[Title/Abstract] OR ‘Pressure Sore’[Title/Abstract] OR ‘Decubitus Ulcer’[Title/Abstract]) AND (‘Foam’[Title/Abstract]) AND (‘Randomized Controlled Trials as Topic’[Mesh] OR ‘randomized controlled trial’[Publication Type] OR ‘random*’[Title/Abstract] OR ‘placebo’[Title/Abstract])
Embase (163)	(‘decubitus’/exp OR ‘Pressure Ulcer’:ab,ti OR ‘pressure ulcer*’:ab,ti OR ‘Bedsore’:ab,ti OR ‘Pressure Sore’:ab,ti OR ‘Decubitus Ulcer’:ab,ti) AND (‘Foam’:ab,ti) AND (‘randomized controlled trial (topic)’/exp OR ‘random*’:ab,ti OR ‘placebo’:ab,ti)
Web of Science (361)	(‘Pressure Ulcer’ OR ‘pressure ulcer*’ OR ‘Bedsore’ OR ‘Pressure Sore’ OR ‘Decubitus Ulcer’) AND (‘Foam’) AND (‘Randomized Controlled Trials as Topic’[Mesh] OR ‘randomized controlled trial’[Publication Type] OR ‘random*’[Title/Abstract] OR ‘placebo’[Title/Abstract])

2.2. Inclusion and exclusion criteria

Two investigators independently evaluated the eligibility of each study based on the following inclusion criteria: participants: community‐based or hospital‐based adult patients; interventions: sacral foam dressings; comparison: standard care without sacral foam dressings; outcome: studies that included one of the following outcomes were considered: SPI rate, ≥ stage II SPI rate; blanching erythema rate; Study design: only randomized controlled trials (RCTs). We excluded the following studies: duplicated articles, abstracts without full texts, editorial comments, letters, case reports, reviews, meta‐analyses, irrelevant titles and abstracts; non‐English article. In addition, if there is potential patient overlap, such as studies conducted by the same author under the same institution across different years, we will only include the most recent study.

2.3. Retrieval of relevant articles

Two independent researchers screened the titles and abstracts following predefined inclusion and exclusion criteria. They then assessed the full texts to verify each study's eligibility. In cases of disagreement, a third researcher was consulted, with discussions continuing until consensus was achieved.

2.4. Quality assessment

For randomized control trials, two reviewers independently assessed quality using the Cochrane Risk of Bias Tool. ¹⁶ The quality assessment was conducted across seven domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting and other potential sources of bias. Each domain was rated as high risk of bias, unclear risk of bias or low risk of bias.

2.5. Data extraction

Two researchers independently conducted data extraction for all included articles. The extracted data included the author, year, study characteristics (country, study design, outcome, comparison) and patient characteristics (mean age, female/male, number of patients, surgery). Disagreements between the researchers were resolved via discussion until a consensus was reached.

2.6. Outcome measures

The primary outcome measures were SPI rate with any stage. Secondary outcome measures included ≥stage II SPI rate and blanching erythema rate. Pressure injury stage definition and staging have been determined following the 2019 European Pressure Ulcer Advisory Panel (EPUAP), NPIAP and the Pan Pacific Pressure Injury Alliance (PPPIA) classification. ⁶

2.7. Statistical analysis

We calculated the pooled effect estimates for binary outcomes (e.g., SPI rate) using risk ratio (RR) with corresponding 95% confidence intervals (CIs). ¹⁷ The Cochrane Q and I ² statistics were used to assess the heterogeneity within and between groups. ¹⁸ If the heterogeneity between the studies differed significantly (p < 0.10 or I ² ≥ 50%), random effect model would be applied and sensitivity analysis would be performed by reassessing the result following the omission of articles one by one. ¹⁹ Meta‐regression analysis cannot be performed to explore potential sources of heterogeneity due to the limited number of included studies (less than 10). ²⁰ If the heterogeneity was low (p > 0.10 or I ²<50%), we would conducted a fixed‐effects meta‐analysis for comparison.

Publication bias was evaluated using a funnel plot and Egger's test. ²¹ For all statistical tests except heterogeneity (p < 0.10), a two‐tailed p‐value below 0.05 was deemed statistically significant. Statistical analyses were performed using the R version 4.3.1.

3. RESULTS

3.1. Literature search and study selection

The initial search yielded a total of 687 publications. Of these, 231 were identified as duplicates, and an additional 440 did not meet the eligibility criteria, resulting in their exclusion from the study. A thorough review of the full texts of the remaining 16 articles led to the further exclusion of seven studies due to insufficient data for outcome (n = 4), non‐randomized control trials (n = 2) and non‐English full text (n = 1). Ultimately, nine articles comparing the efficacy of sacral foam dressing in preventing SPI were included in the meta‐analysis. ⁸ , ⁹ , ¹¹ , ¹² , ²² , ²³ , ²⁴ , ²⁵ , ²⁶ Figure 1 presents the PRISMA flow diagram illustrating the selection process.

FIGURE 1.

PRISMA flow diagram illustrating the study selection process.

3.2. Study description and quality assessment

The 9 eligible randomized controlled studies included a total of 3972 patients. The number of patients in each study ranged from 66 to 1605. The multilayer soft silicone foam dressing Mepilex Border was prominently used in four studies. Allevyn Life, recognized for its multilayer silicone and polyurethane foam dressing, was another commonly selected product across three studies. Additionally, the silicone adhesive multilayer foam dressing variant, Allevyn Gentle Border, was employed in one of the studies. Notably, one study included both Allevyn Life and Mepilex Border Sacrum, illustrating a combined approach to foam dressing usage. The study and patient characteristics are summarized in Table 2.

TABLE 2.

The study characteristics of the included studies.

Author	Year	Country	Study design	Outcome	Comparison	Mean age ± SD	Male/Female	Number of patients	Surgery
Yeo et al.	2023	South Korea	Randomized controlled trial	(1) (3)	Foam dressing, multilayer soft silicone foam dressing (Mepilex Border)	51.56 ± 16.01	45/26	71	Colorectal surgery (33), Hepatectomy (27), Gastrectomy (11)
					Standard care without foam dressing	52.63 ± 15.68	40/33	73	Colorectal surgery(39), Hepatectomy (26), Gastrectomy (8)
Forni et al.	2022	Italy	Randomized controlled trial	(1) (2)	Foam dressing, multilayer silicone dressing (Allevyn Life)	77.5 ± 13.6	157/194	351	NA
					Standard care without foam dressing	78.2 ± 13.0	156/202	358	NA
Lovegrove et al.	2022	Australia	Randomized controlled trial	(1)	Foam dressing, silicone adhesive multilayer foam dressing (Allevyn Life)	84.9 ± 8.4	24/42	66	NA
					Standard care without foam dressing	84.9 ± 6.4	21/43	64	NA
Beeckman et al.	2021	Belgium	Randomized controlled trial	(2)	Foam dressing, silicone adhesive multilayer foam dressing (Allevyn Life and Mepilex Border Sacrum)	NA	458/608	1066	Surgery (114)
					Standard care without foam dressing	NA	223/316	539	Surgery (55)
Gazineo et al.	2020	Italy	Randomized controlled trial	(1) (2)	Foam dressing, multilayered polyurethane foam dressing (Allevyn Life)	83.8 ± 6.3	10/24	34	Hip fracture surgery (34)
					Standard care without foam dressing	84.5 ± 20	14/20	34	Hip fracture surgery (34)
Oe et al.	2020	Japan	Randomized controlled trial	(1)	Foam dressing, multilayer silicone foam dressing (Mepilex Border)	75.6 ± 15.3	161/139	300	NA
					Standard care without foam dressing	74.2 ± 16.2	150/150	300	NA
Lee et al.	2019	South Korea	Randomized controlled trial	(1) (3)	Foam dressing, multilayer silicone adhesive dressing (Allevyn Gentle Border)	65.34 ± 16.92	19/16	35	NA
					Standard care without foam dressing	59.54 ± 18.16	15/16	31	NA
Santamaria et al.	2018	Australia	Randomized controlled trial	(1) (2)	Foam dressing, multilayer silicone foam dressing (Mepilex Border)	84 ± 9	48/90	138	NA
					Standard care without foam dressing	82 ± 12	38/112	150	NA
Kalowes et al.	2016	USA	Randomized controlled trial	(1) (2)	Foam dressing, multilayer soft silicone foam dressing (Mepilex Border)	64.6 ± 17.7	103/81	184	NA
					Standard care without foam dressing	67.3 ± 16.2	100/82	182	NA

Note: (1) Sacral pressure injury rate; (2) ≥stage II sacral pressure injury rate; (3) blanching erythema rate.

Abbreviations: NA, not available; USA, United States of America.

The application of the Cochrane Risk of Bias Tool yielded insights into the risk of bias within the studies, which was shown in Figure 2. A notable high risk and unclear risk of bias were predominantly observed in three domains: random sequence generation, blinding of outcome assessment and selective reporting. However, despite these identified areas of potential concern, the overall risk of bias was deemed satisfactory.

FIGURE 2.

Quality assessment employing the Cochrane Risk of Bias Tool. Each domain is evaluated as low risk of bias (represented by green), unclear risk of bias (represented by yellow) or high risk of bias (represented by red).

3.3. Quantitative results of SPI rate

A total of 8 studies were analysed, and random‐effect models were applied as significant heterogeneity (I ² = 50% and p = 0.05). The SPI rate was significantly lower in the sacral foam dressing group than in the standard care group (RR: 0.37, 95% CI: 0.17–0.82) (Figure 3). Due to the considerable heterogeneity, leave‐one out sensitivity analysis was conducted. After the removal of Gazineo et al., the heterogeneity became acceptable (I ² = 0%) (Figure 4). However, the outcomes remained consistent even after the removal of individual articles, which implies the robustness of the current result (Figure 4).

FIGURE 3.

Forest plot illustrating the comparison of sacral pressure injury rate between the sacral foam dressing group and the standard care group. The plot delineates individual study effect sizes (denoted by squares) alongside their corresponding 95% confidence intervals (represented by horizontal lines) and the aggregate pooled effect size (illustrated by a diamond) reflecting the combined data from all studies.

FIGURE 4.

Sensitivity analysis for the sacral pressure injury rate between the sacral foam dressing group and the standard care group. The plot displays individual study effect sizes (denoted by squares) with corresponding 95% confidence intervals (horizontal lines) after sequentially removing one study at a time from the meta‐analysis.

3.4. Quantitative results of ≥stage II SPI rate

A total of five studies were analysed, and fixed‐effect models were applied as no significant heterogeneity (I ² = 20% and p = 0.29). The ≥stage II SPI rate was significantly lower in the sacral foam dressing group than in the standard care group (RR: 0.56, 95% CI: 0.37–0.83) (Figure 5).

FIGURE 5.

Forest plot illustrating the comparison of ≥ stage II sacral pressure injury rate between the sacral foam dressing group and the standard care group. The plot delineates individual study effect sizes (denoted by squares) alongside their corresponding 95% confidence intervals (represented by horizontal lines) and the aggregate pooled effect size (illustrated by a diamond) reflecting the combined data from all studies.

3.5. Quantitative results of blanching erythema rate

A total of 2 studies were analysed, and fixed‐effect models were applied as no significant heterogeneity (I ² = 0% and p = 0.78). The blanching erythema rate was significantly lower in the sacral foam dressing group than in the standard care group (RR: 0.64, 95% CI: 0.42–0.97) (Figure 6).

FIGURE 6.

Forest plot illustrating the comparison of blanching erythema rate between the sacral foam dressing group and the standard care group. The plot delineates individual study effect sizes (denoted by squares) alongside their corresponding 95% confidence intervals (represented by horizontal lines) and the aggregate pooled effect size (illustrated by a diamond) reflecting the combined data from all studies.

3.6. Publication bias

Funnel plot and Egger's test were performed in SPI rate outcome. No obvious publication bias was observed in the funnel plot (Egger's p values = 0.91) (Figure 7).

FIGURE 7.

Funnel plot and Egger's test assessing publication bias of sacral pressure injury rate in the comparison between the sacral foam dressing group and the standard care group. p < 0.05 was considered significant.

4. DISCUSSION

According to the 2019 EPUAP/NPIAP/PPPIA Guide, foam dressings are recommended for the management of Stage II and greater pressure injuries, especially in cases exhibiting moderate to heavy exudate. ⁶ However, the efficacy of foam dressings in mitigating pressure injury rates, particularly in the sacral region, remains a topic of debate. Several randomized control trials have demonstrated no significant advantage of sacral foam dressing interventions over standard care without foam dressing, ¹¹ , ²² , ²³ thereby engendering a persisting controversy surrounding the specific effectiveness of sacral foam dressings in preventing SPI. This controversy underscores the necessity for a systematic review and meta‐analysis to delineate the precise impact of sacral foam dressings in the prevention of SPIs.

In this systematic review and meta‐analysis, we observed a significant reduction in SPI rates with the use of sacral foam dressings. The findings revealed that the SPI rate was significantly lower in the sacral foam dressing group compared with the standard care group (RR: 0.37, 95% CI: 0.17–0.82). Furthermore, the rate of ≥stage II SPI was also significantly reduced (RR: 0.56, 95% CI: 0.37–0.83), along with a lower blanching erythema rate (RR: 0.64, 95% CI: 0.42–0.97). The possible mechanisms behind these outcomes could be attributed to the pressure redistributive and shear alleviating properties of foam dressings, which provide a protective barrier, mitigating the mechanical forces implicated in pressure injury development and progression. ²⁷ , ²⁸

Our findings consisted with the conclusions drawn by Fulbrook et al. ²⁹ who found that sacral protective dressings could significantly lower pressure injury risks (RR: 0.30, 95% CI: 0.17–0.51). However, the limited number of studies (only six) included in their analysis could potentially influence the level of the evidence. Our analysis augments the existing literature by incorporating more randomized control studies and including additional outcomes (≥II SPI rate and blanching erythema rate). Similarly, in 2021, another meta‐analysis performed by Gong et al. noted a significant reduction in pressure injury incidence with sacral protective dressings (OR, 0.39; 95% CI, 0.28–0.53) compared with standard care. ¹³ However, their study had potential patient‐overlap bias and included retrospective studies, which may have impacted the validity of their findings. Our study attempts to overcome these limitations by ensuring a more stringent inclusion criterion, thereby contributing to a more reliable and comprehensive understanding of the efficacy of sacral foam dressings in preventing SPI.

The initial heterogeneity observed in our analysis for SPI was substantial (I ² = 50%). In order to find out the potential source of heterogeneity, we used sensitivity analysis to identify potential sources. The removal of the study by Gazineo et al. ²² considerably reduced the heterogeneity (I ² = 0%), which may be attributed to the unique patient population criteria as they only include patients aged 65 years and older with a diagnosis of fragility hip fracture. Older patients with fragility hip fractures might have a higher baseline risk for developing such injuries compared with a broader patient population. However, sensitivity analysis shown that the outcomes remained stable even after the removal of individual articles, which implies the robustness of the current result.

Sacral foam dressings, notably multilayer foam varieties, play a critical role in pressure injury prevention by redistributing pressure, minimizing shear forces and maintaining a moist wound environment conducive to healing. Their ease of application and removal, coupled with their ability to act as a protective barrier against contamination, makes them an ideal prophylactic tool against pressure injuries. ²⁸ However, on the contrary, they may not be suitable for wounds with heavy exudate, can be costlier than other preventive measures and may cause skin maceration if not changed regularly. ³⁰ , ³¹ Additionally, individual patient reactions to the dressing material may vary. ³²

The current analysis has several limitations. Firstly, in terms of practical application, the pooled effects of the meta‐analysis warrant cautious interpretation due to the high heterogeneity observed among the included studies. Secondly, the diverse patient population, encompassing different ages and ethnicities, and varied surgical procedures across the included patient populations, may affect the generalizability of the results. Thirdly, the inclusion of RCTs with different foam dressings from various manufacturers may present inconsistencies, as the compositions of the dressings could slightly differ, potentially impacting the overall efficacy in preventing SPIs. These limitations underline the necessity for further larger, well‐designed randomized control studies to confirm the findings.

5. CONCLUSION

Sacral foam dressing significantly reduced the incidence of SPIs, including those of stage II or higher, and blanching erythema when compared to standard care without sacral foam dressing. However, the results should be interpreted with cautious because of the observed heterogeneity and the diverse patient group. Further larger, well‐designed randomized control studies are needed.

FUNDING INFORMATION

The current research of our article was funded by the Chinese Medicine Research Program of Zhejiang Province (2024ZL034).

CONFLICT OF INTEREST STATEMENT

The authors confirm that this study was performed without any commercial or financial affiliations that could be construed as a potential conflict of interest.

Xia J, Huang K, Jiang Q, Wang W. The efficacy of sacral foam dressing in preventing sacral pressure injury: A systematic review and meta‐analysis. Int Wound J. 2024;21(2):e14673. doi: 10.1111/iwj.14673

DATA AVAILABILITY STATEMENT

The original findings detailed in this study can be found within the article. For additional inquiries, please contact the corresponding authors.