Use of a Hydrocolloid Dressing in the Prevention of Device-related Pressure Ulcers During Noninvasive Ventilation: A Meta-analysis of Randomized Controlled Trials

Use of a hydrocolloid dressing (HCD) is generally recommended to help prevent pressure ulcers (PUs) in high-risk patients, including ulcers caused by noninvasive ventilation (NIV). Purpose: The study was conducted to compare the effect of preventive use of HCD to other methods in the rate of facial PUs caused by NIV. Methods: PubMed, Web of Science, China National Knowledge Infrastructure, and Wanfang Data were searched from date of index inception to August 2018 without language restrictions to identify randomized controlled trials (RCTs) that compared HCD use to other NIV-related PU prevention measures. Publications were systematically reviewed, data were extracted, and study quality was assessed using the Jadad scale. Odds ratio (OR) with 95% confidence intervals (CIs) for PU incidence in patients using HCD versus patients managed with gauze or standard skin care procedures (control) were calculated using a fixed-effects model. Results: The search yielded 80 publications; 40 met the study criteria for full-text and 22 met the meta-analysis inclusion criteria (total study participants = 2519). Patients who used a HCD (n = 1260) had a significantly decreased incidence of PU (OR = 0.15; 95% CI: 0.11-0.20) compared with control group patients (n = 1259). Subgroup analysis by age showed a lower incidence in children (OR = 0.09; 95% CI: 0.01-0.81) and adults (OR = 0.16; 95% CI: 0.12-0.22) in the HCD group than in the control group. PU incidence using HCD was lower compared to gauze (OR = 0.17; 95% CI: 0.10-0.28) and regular skin care (OR = 0.13; 95% CI: 0.09-0.19). Funnel plot diagrams suggested a risk of bias. Sensitivity analysis using a random-effects model did not change the result of the main meta-analysis. Conclusion: Using a HCD significantly decreased the incidence of facial PUs caused by NIV. Additional high-quality, prospective research to confirm the effectiveness of HCD in preventing NIV-related PUs is warranted.

The latest guidelines from the National Pressure Ulcer Advisory Panel¹ (NPUAP) include medical device-related pressure ulcers (PUs), defined as a localized injury to the skin or underlying tissue as a result of sustained pressure from a medical device,  and mucosal membrane pressure ulcers as pressure injury categories.¹ Medical device-related PUs differ from classic PUs in that they are caused by essential therapeutic equipment (including respiratory devices), occur in both the skin and mucous membranes, and do not usually lie over a bony prominence.² Medical device-related PUs are part of hospital-acquired PU evaluation.

Noninvasive ventilation (NIV) is the application of positive pressure via the upper respiratory tract in order to augment alveolar ventilation and provide respiratory support³ without intubation. According to retrospective, cohort research and literature review,^4-6 the advantages of NIV compared with invasive ventilation include a lower incidence of upper airway injury, lower mortality rates, fewer instances of laryngeal stenosis and nosocomial pulmonary infection, a decreased need for sedative or paralytic drugs, and fewer lengthy hospital stays. As shown in 2 review studies,^7,8 use of this technology has grown exponentially, and it has become an integral tool in the treatment of acute and chronic respiratory failure. Use of NIV initially was restricted to intensive care units and respiratory medicine wards; according to a randomized controlled trial⁹ (RCT), it now is used for care provided before the patient enters the hospital, including home management of patients with chronic conditions.

PUs are a common complication of NIV. In a prospective, longitudinal observational study¹⁰ that analyzed 51 patients with noninvasive positive pressure ventilation, 31 patients developed PUs, representing a cumulative incidence rate of 60.8%. A before-after comparison study¹¹ conducted in 5 intensive care units at a university-affiliated medical center showed PUs developed in 20% of patients that used nasal-oral masks and in 2% that used full-masks. In a cross-sectional retrospective study¹² (N = 40), the incidence of facial skin injury in children was 48%. The development of PUs is associated with adverse outcomes that may contribute to patient pain and suffering, impaired quality of life, prolonged hospital stay, and increased hospital costs.^13-15

Prevention usually is considered the most efficient method to address PUs caused by NIV. The NPUAP¹⁶ recommends using wound dressings such as transparent film, silicone, thin foam, or hydrocolloid to reduce friction and shear to prevent PU. Weng¹⁷ conducted a quasi-experimental study (N = 90) to compare the efficacy of protective dressings (Tegasorb and Tegaderm; 3M, St Paul, MN) versus using no materials for PU prevention in patients with NIV. The incidence of PU among the 3 groups was 0.4, 0.533, and 0.967, respectively (P <.01). The study showed the potential protective effect of hydrocolloid dressings on facial PUs caused by NIV. Results of a prospective controlled study¹⁸ indicated use of hydrocolloid dressings decreased the incidence of nasal trauma in preterm infants with NIV, possibly because the mask was sealed so as to reduce excessive pressure. However, hydrocolloid dressing use to prevent PUs caused by NIV remains controversial. Riquelme et al¹⁹ constructed a simulated model of NIV that showed an inability of the hydrocolloid dressing to reduce facial pressure, leading the authors to conclude hydrocolloid dressings did not help prevent PUs in patients with NIV.

The aim of this systematic review was to determine the effectiveness of hydrocolloid dressing use in the prevention of facial PUs caused by NIV.

Search strategy. PubMed, Web of Science, China National Knowledge Infrastructure, and Wanfang Data were searched for RCTs published from date of index inception until August 2018 using the terms pressure ulcer, pressure injury, pressure sore, bedsore, decubitus, noninvasive, ventilation, dressing, hydrocolloid, and water colloid. No search restrictions were imposed related to country, language, or year of publication. The reference lists from retrieved articles also were searched to obtain additional studies.

Inclusion and exclusion criteria. This systematic review only included studies where a hydrocolloid dressing was used as the prevention variable for PU in patients with NIV. Other inclusion criteria were: the study was an RCT, the objective was assessing the effectiveness of a hydrocolloid dressing (regardless of brand) in preventing facial PU, the intervention comparison involved a hydrocolloid dressing versus a control, and the outcome was the incidence of facial PUs. Studies were excluded if the number of patients developing PUs or the incidence of PUs was not reported; duplicate publications or duplicate reporting of patient cohorts also were excluded.

Data extraction. The following data of eligible publications were collected: first author, publication year, study design, country, sample size, participant age, preventive intervention (the control was use of regular skin care or gauze dressings), PU incidence, and PU stage. The information was extracted independently by 2 authors, and disagreement was resolved by discussion and consensus between them.

Quality assessment. The Jadad²⁰ scale was used to assess the methodological quality of all included studies. The tool included randomized sequence generation, blinding, and loss of participants to follow-up. Points were calculated as follows: a proper randomization and proper blinding received 2 points each, reporting withdrawals and dropouts received 1 point. The total score of reviewed studies ranged from 0 to 5; a score <2 indicated poor methodological quality.

Statistical analysis. The primary outcome analyzed was the incidence of facial PUs caused by NIV in the hydrocolloid dressing and control group. For analysis of the dichotomous variables (PU development), odds ratio (OR) and 95% confidence interval (CI) were reported for outcomes. Statistical heterogeneity was assessed using χ² and inconsistency (I²) statistics. I² >50% indicated significant heterogeneity and the results were interpreted with caution.²¹ If no heterogeneity was found, a fixed-effects model was used for meta-analysis; otherwise, the DerSimonian and Laird random-effect model was used.²² Overall effects were evaluated by the Z test. A 2-sided P value <.05 was considered statistically significant. Publication bias was evaluated by funnel plot. Asymmetry in funnel plots indicated publication bias in meta-analysis. Sensitivity analysis was performed by changing the effect model. Subgroup analyses were considered when the participants were at different age levels or used different control group interventions. All statistical analyses were conducted using Review Manager Software, version 5.3 (Cochrane Collaboration, Oxford, England).

Results of document retrieval. A total of 80 publications were found; after duplicates were removed, 58 studies remained and of those, 18 were excluded upon abstract review. After reviewing 40 full-text articles, 8 studies were excluded because they were not randomized and 10 studies were excluded due to no available data (ie, the studies did not report the number of patients who developed PU or the incidence of PU in hydrocolloid dressing and control groups). The remaining 22 studies^23-44 were included for analysis (see Figure 1), yielding a total of 2519 patients, including 368 NIV patients with PUs. The number of participants in the hydrocolloid dressing and control groups was 1260 and 1259, respectively; 67 PUs developed in the hydrocolloid dressing and 301 developed in the control group.

Participants in 3 studies^35,37,43 were children (maximum age 25 months), and 19 studies^{23-34,36,38-42,44} included adult and geriatric patients (minimum age >19; 1 study²⁶ did not specify exact adult age). Participants in treatment groups were provided hydrocolloid dressings before putting on the NIV face masks. Control group interventions included gauze dressings or regular skin care; in 9 studies,^{23,27,29,30,32-34,39,44} gauze was applied to skin beneath the mask. In 13 studies^{24-26,28,31,35-38,40-43} no dressing materials were applied; clinicians of patients who used NIV continuously for more than 2 hours were instructed to relax the headband, take off the mask for 10 to 15 minutes, keep the face clean and dry, and observe the skin condition. Skin care (keeping facial skin clean and dry, relaxing the NIV strap regularly, maintaining proper strap tightness, and observing the skin condition at intervals) was used to prevent PU development. In 4 studies,^27,31,38,42 regular skin care involved Comfeel dressings (Coloplast Corp, Humlebaek, Denmark), and in 2 studies^36,44 Algoplaque dressings (URGO Company, Paris, France) were provided. The table summarizes the characteristics of the 22 studies assessed in the final meta-analysis.

Main meta-analysis. The incidence of PU caused by NIV was 5.31% in the hydrocolloid dressing group and 23.91% in the control group. No heterogeneity was found among the included studies (χ² = 23.63; P = 0.31; I² =1 1%). Using a fixed-effect model, the summary OR of patients in hydrocolloid dressing group compared with patients in the control group was 0.15 (95% CI: 0.11–0.20; Z = 12.72; P <.00001) (see Figure 2). The overall effect showed hydrocolloid dressing use significantly decreased the development of PUs in patients with NIV. Sensitivity analysis using a random-effect model found the summary OR of patients was 0.16 (95% CI: 0.11–0.22; Z = 10.9; P <.00001). The sensitivity analysis did not materially change the result of the meta-analysis, indicating the outcome of the meta-analysis was robust (see Figure 3). The funnel plot showed asymmetry, suggesting a publication bias in this meta-analysis (see Figure 4).

Results of subgroup analysis. The meta-analysis of pediatric patients showed that in the hydrocolloid dressing group, 4 patients (1.28%) developed PUs versus 38 (12.14%) in the control group (OR = 0.09; 95% CI: 0.01-0.81; P = .03). In the 19 studies^{23-34,36,38,42-44} that included adult and geriatrics patients, 63 patients (6.65%) developed PUs in the hydrocolloid dressing group versus 263 (27.80%) in the control group (OR = 0.16; 95% CI: 0.12-0.22; P<.00001). Forest plot chart analysis indicated no differences in OR estimates were found across all age groups (see Figure 5).

In the 9 studies^{23,27,29,30,32-34,39,44} in which gauze was the control, meta-analysis showed 27 patients (6.01%) in the hydrocolloid dressing group developed PUs versus 108 (23.53%) in the control group (OR = 0.17; 95% CI: 0.10-0.28; P <.00001). In the 13 studies^{24-26,28,31,35-38,40-43} in which regular skin care was the control, 40 patients (4.93%) developed PUs in hydrocolloid dressing group versus 193 (24.13%) in the control group (OR = 0.13; 95% CI: 0.09-0.19; P <.00001). Forest plot chart analysis indicated no differences in OR estimates were found among different interventions in the control group (see Figure 6).

This meta-analysis of 22 studies^23-44 demonstrated that a hydrocolloid dressing was significantly more effective in preventing facial PUs caused by NIV than gauze or what was termed regular skin care, decreasing the incidence of facial PUs caused by NIV (OR = 0.15; 95% CI: 0.11–0.20; Z = 12.72; P <.00001). In a prospective controlled trial,⁴⁵ the incidence of nasal injury using silicone gel sheeting on the surface of the nostrils was 4.3% in neonates versus 14.9% in patients who did not use silicone gel. In a prospective study⁴⁶ (N = 47) of patients who needed NIV, the use of water to seal the facial mask decreased the incidence of facial PUs. These 2 studies reported the use of different methods to prevent facial PUs, but the outcome was similar to the current research.

NIV usually involves a mask or similar device to provide ventilation support⁴⁷; correct mask placement is a key factor in the successful use of NIV, as noted in a  quasi-experimental study¹⁷ that showed that in normal clinical practice, masks used in NIV are tightly fitted to the face to prevent air leaks and if fitted too tightly, PUs can develop. This is especially true in areas where the skin covers thin subcutaneous tissue (chin, cheekbones, forehead, and nasal bridge) and excessive pressure predisposes to the development of PU.¹¹ A review of the literature⁴⁸ has shown patients with NIV need to wear masks for a long time, and pressure-induced ischemia at 35 mm Hg for a duration of 2 hours can inflict tissue damage and necrosis.⁴⁸ In the pediatric population, particular risk factors include immature skin, and masks in less-than-optimal size and fit for the facial anatomy of each child.^19,49

Riquelme et al¹⁹ constructed a simulated model of NIV using a total face mask and explored preventive strategies for facial PUs that involved the use of suitable masks, fixed optimal pressure, and unspecified periodic revision of the skin. In a before-after study¹¹ of a convenience sample of patients with NIV (N = 200), full-face masks were considered a reasonable alternative to traditional nasal-oral masks because their use resulted in significantly fewer PUs and more comfort for patients in intensive care units. Dressings can be used to eliminate the gap between the skin and the mask to achieve a proper fit as well as to redistribute the pressure. Moreover, clinicians need training on the proper application of the NIV mask, especially correct mask placement and angle.^17,50 A prospective cohort study⁵¹ (N = 3233) has suggested continuous monitoring is desirable for facial PU prevention.

Hydrocolloid dressings are a viable option for use in preventing PUs because they are occlusive, waterproof, and impermeable to bacteria and other contaminants. A meta-analysis⁵² conducted to determine the effectiveness of dressing material in the prevention of PUs has shown the dressing to absorb small to moderate amounts of moisture to keep the skin intact. In an experimental study, Ohura et al⁵³ measured the physical properties of dressings with regard to shear force; results indicated the coefficients of static friction were 1.01 for hydropolymer, 0.72 for hydrofoam, and 0.48 for hydrocolloid. Therefore, a hydrocolloid dressing was considered the most effective material to address shear force in dry conditions. The prospective study by Weng et al¹⁷ of 90 patients with NIV that evaluated the capacity of both hydrocolloid and transparent polyurethane dressings to prevent facial PUs found no significant difference in skin deterioration between the 2 groups, but PU incidence was 40% in the hydrocolloid dressing group and 53.3% in polyurethane film group. In their prospective study, Callaghan and Trapp⁵⁴ reported the hydrocolloid dressing group had less skin deterioration over time compared with the transparent polyurethane group in patients using nasal intermittent positive pressure ventilation. Therefore, the hydrocolloid dressing is effective in preventing facial PUs and protecting the skin.

Several limitations are inherent to meta-analyses. In this study, most publications had a Jadad score of 2, indicating the studies were of low quality and biased. In addition, no English language studies were found; the included articles were all Chinese studies, which may contribute to bias and make it challenging for non-Chinese researchers to confirm current findings. Finally, the funnel plot showed asymmetry, and publication bias was found. The final conclusion was that more high quality RCTs involving other ethnicities are needed.

A meta-analysis of 22 RCTs showed use of a hydrocolloid dressing effectively decreased the incidence of facial PUs in patients with NIV. Because the conclusions reached were mostly based on low-quality RCTs, the findings need to be further verified with more high quality RCTs. This research could help support the role of hydrocolloid dressings in preventing facial PUs caused by NIV.

Ms. Cai and Ms. Zha are graduate students; and Dr. Chen is a professor, School of Nursing, Nantong University, Nantong City, Jiangsu Province, PR China.

Please address correspondence to: Hong-Lin Chen, MD, School of Nursing, Nantong University, Nantong City, Jiangsu Province, PR China: email: honglinyjs@126.com.