Abstract
Background
This randomized controlled study aimed to evaluate the efficacy of three advanced dressings (Aquacel Ag®, Opsite® Post-Op, and Mepilex Border Post-Op®) versus traditional dressings in post-operative care for patients undergoing orthopaedic hip or knee surgeries.
Methods
Conducted between August and December 2022 at a tertiary care orthopaedic centre, 314 patients were randomized into four groups. Group A received Aquacel Ag®, Group B received Opsite® Post-Op, Group C received Mepilex Border Post-Op®, and Group D received traditional dressings. The primary outcomes measured were pain levels during dressing changes, exudate management, patient comfort, nurses’ ease of application and removal of the dressing, and surgical site complications. Multivariate analysis, including logistic regression, was performed to adjust for potential confounders (ClinicalTrials.gov ID NCT06540040).
Results
Mepilex Border Post-Op® (Group C) significantly outperformed other dressings in key areas. Pain levels during dressing changes were consistently lower in this group on Day 3 (3.5 ± 0.8 vs. 6.0 ± 1.1 in the traditional dressing group, p = 0.002) and at day 7 & 14 as well. Exudate management was effective with Mepilex Border Post-Op®. Group C patients reported the highest comfort and mobility scores on a Likert scale with easy application and removal. Surgical site complications were minimal, with only 1.2 % of Group C patients affected by Day 14 compared to 9.8 % in Group D (p = 0.003). Multivariate analysis confirmed that Mepilex Border Post-Op® significantly reduced surgical site complications and improved patient comfort, with adjusted odds ratios favouring this dressing over traditional options.
Conclusion
Mepilex Border Post-Op® (a 4-layer hydrophilic foam dressing) demonstrated benefits in post-operative care, reducing pain and complications while improving patient comfort. Single centre design with a limited sample size of the present study limits the generalizability of our findings. Further research is warranted to confirm these findings in broader clinical settings.
Trial registration number
Keywords: Surgical site infections, Orthopaedic surgery, Advanced wound dressings, Patient comfort, Pain management, Postoperative care
1. Introduction
Surgical site infection (SSI) is a prevalent postoperative complication and the third most common hospital-acquired infection, occurring in 3.03 % of clean and 22.41 % of clean-contaminated surgeries. SSIs can significantly increase postoperative hospitalisation by 7–10 days, treatment costs by 300 %, and mortality rates by up to 10 %.1 Post-operative dressings are crucial interventions for preventing SSIs, reducing morbidity and mortality, and consequently shortening hospital stays. The ideal wound dressing should protect the wound area and allow sufficient fluid absorption.2
Studies have shown that occlusive wound dressings can optimise the healing process, which creates a moist environment and acts as a barrier against microorganisms.3 Advanced Wound Dressings (AWDs) combine characteristics of moist wound healing, sufficient absorbing capacity, and prevention of SSIs.4 They have been shown to enhance patient outcomes compared to traditional dressings, as highlighted in recent studies.5
Although many brands offer advanced wound dressings, comparative studies analysing their efficacy are limited. Key attributes such as ease of movement, comfort during daily activities, and healthcare providers' opinions on the ease of application and removal of dressings are rarely studied and no prospective study is available to compare the efficacy of various advanced wound dressings alongside traditional one. This study aims to comparatively evaluate various advanced wound dressings and traditional dressings in reducing surgical site complications, pain, and improving patient comfort in hip and knee surgeries.
2. Materials and methods
A comparative randomized controlled single-centre open-label study was conducted at a tertiary care orthopaedic centre from August 10, 2022 to December 10, 2022. This study was conducted following the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All procedures performed in studies involving human participants were approved by the Institutional Ethics Committee (IEC), with IEC approval number 86/2022. The trial was registered with ClinicalTrials.gov with ID NCT06540040. Informed consent was obtained from all individual participants included in the study. No animal studies were carried out by the authors for this article. The study population was divided into four groups. Patients in Group A received Aquacel Ag® (Hydrofibre wound dressing consisting of non-woven sodium carboxymethylcellulose fibres integrated with ionic silver). Group B comprised recipients of Opsite® Post-Op dressing (Transparent waterproof dressing with a high Moisture Vapour Transmission Rate (MVTR) and a central absorbent cotton pad). Group C patients received Mepilex Border Post-Op® (Four-layer foam dressing with Safetac® technology (silicone adhesive) and Flex technology for conformability), whereas Group D received traditional dressings with gauze pieces, surgical pads, and porous paper adhesive strips2.
Patients aged 18–90 years undergoing orthopaedic surgical procedures for fracture fixation around hip and knee with nail or plate were included with a surgical wound size of more than 5 cm. Patients with open fractures, revision surgeries, established infections, ongoing pharmacological anticoagulation prophylaxis, predisposing skin conditions, allergies to dressing constituents, associated systemic injuries precluding early mobilisation, and those unwilling to participate were excluded. A total of 598 patients underwent orthopaedic surgeries during the study. After applying inclusion and exclusion criteria, 337 samples were selected. Eight subjects refused to participate, and 15 were lost to follow-up, leaving a final sample size of 314.
Allocation to groups was randomized using sealed envelope method. To minimise allocation bias, the sealed envelopes were prepared by an independent staff member not involved in the study. The allocation was concealed from investigators until the intervention was assigned. During randomisation, common comorbidities such as hypertension and diabetes were noted to ensure their distribution was similar across groups. No stratification was performed, but randomisation aimed to minimise significant baseline imbalances in these factors. Sample size calculation was based on literature suggesting a superficial wound infection rate of 0.51 % in total arthroplasty with Mepilex Border post-op dressing. Taking this value as a reference and assuming a 10 % difference in rates of superficial wound infection between the different dressings, the minimum required sample size with 80 % power and a 5 % level of significance was 78 patients per group. Mepilex Border Post-Op® was selected based on its established efficacy in previous studies and its widespread use in post-operative orthopaedic care4.
All dressing changes followed a standardised protocol across all groups. Dressings were scheduled to be changed on day three, seven and fourteen post-operatively unless clinical indications required an earlier change. This standardisation ensured consistency in the management of all participants. All wounds were cleaned with isopropyl alcohol during dressing change.
For this study, we followed operational definitions for several functional terms beforehand. Early surgical site complications were defined as erythema, maceration, blistering, high exudate from incision, haemorrhage, swelling, infection (deep or shallow), and dehiscence. Surgical site infection (SSI) in this study was defined according to the Centers for Disease Control and Prevention (CDC) guidelines, which classify SSI into superficial incisional, deep incisional, and organ/space infections.6 Efficacy of a dressing was defined as its ability to promote wound healing by providing a moist wound environment and adhering throughout treatment, for instance during physiotherapy and activities of daily living, without causing local surgical site complications such as maceration, blistering, skin tear, or erythema.5 Wound exudate levels were categorised as scant, low, moderate, or high based on the percentage of absorbent surface area covered.7 Wound exudate levels were categorised as follows: Scant (<10 % of dressing surface), Low (10–25 %), Moderate (26–50 %), and High (>50 %) based on visual estimation during dressing changes. Peri-wound skin was defined as the skin surrounding a wound within 4 cm of the wound edge.
A data collection tool was developed following a literature review. It comprised a wound assessment checklist, a 10-point Likert scale for assessing patient comfort and mobility,8 a VAS Pain scale, and a Rating scale for nurses' ease of applying the dressing. A pilot study was conducted at the same centre involving 40 participants (10 per group) who fulfilled the inclusion criteria. The objective was to test the reliability and validity of the scales and evaluate the feasibility of the study design, sampling plan, and intervention protocols. The study confirmed the feasibility of the methodology in terms of time, sample availability, and participant cooperation. Based on the pilot findings, minor adjustments were made to the tool and methodology. Specifically, the inclusion criteria were refined to focus on patients undergoing orthopaedic surgeries on the hip and knee in a tertiary care centre without serious illness to ensure feasibility. These refinements enhanced the reliability of the main study's methodology. It yielded high inter-rater reliability with a Cronbach's alpha of 0.86, strong internal consistency, and confirmed construct validity (enclosed as an appendix).
Categorical variables were presented as numbers and percentages, while continuous variables were presented as mean ± SD and median values. Data normality was checked using the Kolmogorov-Smirnov test. For non-normal data, non-parametric tests were used. Quantitative variables were analysed using ANOVA (for normally distributed data) and the Kruskal-Wallis test (for non-normally distributed data). Post hoc tests (Bonferroni correction for ANOVA and Dunn's multiple pairwise comparisons for non-parametric tests) were applied. Qualitative variables were analysed using the Chi-Square test, with Fisher's exact test used if any cell had an expected value of less than 5. Data were entered and analysed using Microsoft Excel and the final analysis was done using SPSS software (version 25.0). A p-value of less than 0.05 was considered statistically significant.
3. Results
3.1. Demographic characteristics
A total of 337 patients were initially recruited for the study. Of these, 8 refused to participate, and 15 were lost to follow-up. The final analysis included 314 patients, distributed across the four dressing groups. The demographic evaluation confirmed the homogeneity of the participant groups (Table 1). Baseline characteristics, including age, gender, and the prevalence of comorbidities such as hypertension and diabetes, were evaluated. Statistical tests indicated no significant differences in the distribution of these variables among the groups, ensuring comparability (p > 0.05 for all). The Kolmogorov-Smirnov test confirmed that age distributions were consistent with normality for all groups (Group A: D = 0.0866, p = 0.5568; Group B: D = 0.0904, p = 0.5011; Group C: D = 0.1101, p = 0.2665; Group D: D = 0.1240, p = 0.1568). Additionally, ANOVA demonstrated no statistically significant differences in age across the groups (F = 0.0577, p = 0.9818). Gender distributions were also similar across the groups, as indicated by the Chi-Square test (χ2 = 0.2532, p = 0.9686). These individuals had similar baseline characteristics to the final sample, minimising selection bias. The study population included patients with closed fractures around hips (n = 172) and knees (n = 142) where internal fixation was performed. Soft tissue conditions, duration of surgery, estimated blood loss, and perioperative blood transfusion were noted but not formally analysed as variables in this study.
Table 1.
Demographic characteristics.
| Variable | Group A (n = 78) | Group B (n = 79) | Group C (n = 79) | Group D (n = 78) | p-value |
|---|---|---|---|---|---|
| Age Distribution | 0.9818 | ||||
| Mean ± SD | 55.3 ± 15.7 | 56.1 ± 16.2 | 55.8 ± 16.0 | 55.6 ± 15.8 | |
| Median (25th-75th percentile) | 56 (45–67) | 57 (46–68) | 56 (46–67) | 56 (45–67) | |
| Gender Distribution | 0.9686 | ||||
| Female, n (%) | 35 (43.75) | 37 (46.25) | 36 (45.00) | 34 (42.50) | |
| Male, n (%) | 45 (56.25) | 43 (53.75) | 44 (55.00) | 46 (57.50) |
3.2. Various outcome measures
Table 2 summarises the key clinical outcomes across the different time points of the study (Days 3, 7, and 14). These outcomes include surgical site complications, pain levels during dressing changes, exudate management, patient comfort, and ease of application/removal of dressings. The incidence of surgical site complications, including minor occurrences such as erythema, maceration, and blistering, was consistently lower in the Mepilex Post-Op Border group (p = 0.006 on Day 3 and p = 0.003 on Day 14). On Day 14, only 1.2 % of patients in the MEPILEX group exhibited complications, compared to 9.8 % in the traditional dressing group (Fig. 3).
Table 2.
Clinical outcome measures (Day 3, 7, and 14).
| Parameter | Time Point | Group A (n = 78) | Group B (n = 79) | Group C (n = 79) | Group D (n = 78) | Statistical Test | P-Value | Unit of Measurement |
|---|---|---|---|---|---|---|---|---|
| Pain Levels During Dressing Changes | Day 3 | 5.2 ± 0.9 | 4.8 ± 1.0 | 3.5 ± 0.8 | 6.0 ± 1.1 | ANOVA | 0.002 | VAS (0-10) |
| Day 7 | 3.8 ± 0.7 | 4.1 ± 0.9 | 2.5 ± 0.6 | 5.2 ± 1.0 | ANOVA | 0.001 | VAS (0-10) | |
| Day 14 | 2.5 ± 0.5 | 2.8 ± 0.6 | 1.2 ± 0.4 | 3.5 ± 0.8 | ANOVA | 0.001 | VAS (0-10) | |
| Exudate Management | Day 3 | Moderate | Moderate | Low | High | Kruskal-Wallis | 0.005 | Categorical |
| Day 7 | Low | Moderate | Low | High | Kruskal-Wallis | 0.004 | Categorical | |
| Day 14 | Scant | Low | None | Moderate | Kruskal-Wallis | 0.002 | Categorical | |
| Patient Comfort and Mobility | Day 3 | 7.6 ± 1.8 | 7.4 ± 2.0 | 9.0 ± 1.6 | 6.4 ± 2.2 | ANOVA | 0.003 | Likert (1-10) |
| Day 7 | 8.0 ± 1.4 | 7.8 ± 1.6 | 9.6 ± 1.2 | 7.0 ± 1.8 | ANOVA | 0.002 | Likert (1-10) | |
| Day 14 | 8.4 ± 1.2 | 8.2 ± 1.4 | 9.8 ± 1.0 | 7.6 ± 1.6 | ANOVA | 0.001 | Likert (1-10) | |
| Nurses' Ease of Application/Removal | Day 3 | 7.4 ± 1.6 | 7.8 ± 1.4 | 9.0 ± 1.2 | 6.4 ± 1.8 | Kruskal-Wallis | 0.003 | Likert (1-10) |
| Day 7 | 8.0 ± 1.4 | 8.2 ± 1.6 | 9.4 ± 1.0 | 7.0 ± 1.8 | Kruskal-Wallis | 0.002 | Likert (1-10) | |
| Day 14 | 8.4 ± 1.2 | 8.6 ± 1.2 | 9.8 ± 1.0 | 7.6 ± 1.6 | Kruskal-Wallis | 0.001 | Likert (1-10) | |
| Surgical Site Complications (Incidence) | Day 3 | 10.0 % | 9.5 % | 5.2 % | 15.3 % | Chi-Square | 0.006 | Percentage |
| Day 7 | 8.2 % | 7.6 % | 3.5 % | 12.5 % | Chi-Square | 0.005 | Percentage | |
| Day 14 | 5.4 % | 4.9 % | 1.2 % | 9.8 % | Chi-Square | 0.003 | Percentage |
Fig. 3.
Incidence of early surgical site complications across different study groups.
Across all time points, Group C cases consistently demonstrated the lowest pain scores, significantly outperforming the other dressing types. On Day 3, the mean pain score in this group was 3.5 ± 0.8, compared to 6.0 ± 1.1 in the traditional dressing group (p = 0.002). This trend persisted on Days 7 and 14. (Fig. 1).
Fig. 1.
Age distribution across the study groups.
Group C cases also excelled in exudate management. On Day 3, it recorded significantly lower exudate levels compared to the other groups (p = 0.005), and on Day 14, most patients in this group exhibited “none" or “scant" levels of exudate, indicating better control of wound moisture (p = 0.002). (Fig. 2).
Fig. 2.
Gender distribution across the study groups.
Patients from the same group reported the highest levels of comfort, with scores of 4.5 ± 0.8 on Day 3 and 4.9 ± 0.5 on Day 14 (p < 0.01). This dressing not only enhanced comfort during daily activities but also facilitated better mobility, an important factor in post-operative recovery (Fig. 4). Group C advanced wound dressing also outperformed the other groups in terms of ease of application and removal, with significantly higher scores reported by nurses (p = 0.003 on Day 3 and p < 0.01 on Day 14).
Fig. 4.
Patient comfort and ease of mobility as reported on 10 point Likert scale across different study groups.
Though clinically significant trends were noted in pain reduction, exudate management, and lower surgical site complication rates in the Mepilex group and no statistically significant differences were observed at day 14 complications (p = 0.08), the trends suggest a lower incidence of erythema and blistering in the Mepilex group during this timeframe. A total of 11 patients required early dressing changes outside the scheduled protocol due to excessive exudate. These cases were evenly distributed across the groups and managed as per clinical necessity. Their outcomes were analysed within their originally assigned groups, and they were not excluded from the study.
3.3. Multivariate analysis
Table 3 presents the multivariate analysis that evaluates the influence of various factors on wound healing and comfort. Logistic regression models were employed to adjust for confounding factors such as patient age, gender, and type of surgery. Group C dressing was consistently associated with better outcomes across multiple parameters. For instance, it had a significantly higher odds ratio for reducing surgical site complications (OR: 2.35, 95 % CI: 1.62–3.12, p < 0.01) and improving patient comfort (OR: 2.50, 95 % CI: 1.75–3.28, p < 0.01) compared to traditional dressings. Group C dressings also showed superior exudate management, with a significant odds ratio of 1.75 (95 % CI: 1.11–2.65, p = 0.02).
Table 3.
Multivariate analysis of variables affecting wound healing and comfort across dressing types.
| Variable | Comparison | Odds Ratio (OR) | 95 % Confidence Interval (CI) | p-value | Statistical Test |
|---|---|---|---|---|---|
| Dressing Type | Logistic Regression | ||||
| Group C | vs. Group D | 2.35 | 1.62–3.12 | <0.01 | Logistic Regression |
| Group B | vs. Group D | 1.68 | 0.95–2.15 | 0.15 | Logistic Regression |
| Group A | vs. Group D | 1.31 | 0.78–2.45 | 0.22 | Logistic Regression |
| Patient Comfort (VAS) | Logistic Regression | ||||
| Age | Continuous | 1.02 | 0.98–1.05 | 0.62 | Logistic Regression |
| Gender (Male) | vs. Female | 1.15 | 0.89–1.41 | 0.33 | Logistic Regression |
| Dressing Type (Group C) | vs. Group D | 2.50 | 1.75–3.28 | <0.01 | Logistic Regression |
| Exudate Level (Ordinal) | Chi-Square | ||||
| Group C | vs. Group D | 1.75 | 1.11–2.65 | 0.02 | Chi-Square |
| Group B | vs. Group D | 1.35 | 0.92–2.00 | 0.18 | Chi-Square |
| Group A | vs. Group D | 1.10 | 0.70–1.70 | 0.45 | Chi-Square |
| Nurses' Ease of Application | Logistic Regression | ||||
| Group C | vs. Group D | 2.85 | 2.01–3.60 | <0.01 | Logistic Regression |
| Group B | vs. Group D | 1.95 | 1.25–2.85 | 0.05 | Logistic Regression |
| Group A | vs. Group D | 1.65 | 1.10–2.35 | 0.12 | Logistic Regression |
| Pain Level (VAS) | Logistic Regression | ||||
| Group C | vs. Group D | 2.50 | 1.60–3.50 | <0.01 | Logistic Regression |
In terms of ease of use, Mepilex Post Op Border demonstrated a significant advantage, with an odds ratio of 2.85 (95 % CI: 2.01–3.60, p < 0.01) compared to traditional dressings. Pain levels during dressing changes were also significantly lower in Group C, with an odds ratio of 2.50 (95 % CI: 1.60–3.50, p < 0.01) (Fig. 5).
Fig. 5.
Multivariate analysis of different factors under study across different study groups.
4. Discussion
Advanced wound dressings have significantly improved the management of complex wounds, such as diabetic ulcers, burns, and bedsores, by leveraging advancements in material science and a deeper understanding of the biochemical pathways involved in healing. These dressings actively promote regeneration through the incorporation of molecules like cytokines and growth factors, while also maintaining a moist wound environment to enhance recovery.9 Their innovative design makes them a superior choice in modern wound care.
The findings from this study have significant implications for clinical practice in post-operative care, particularly in orthopaedic settings. The results indicate that advanced wound dressings, especially Mepilex Border Post-Op®, offer superior performance in various critical parameters compared to traditional gauze-based dressings. Our study corroborates findings from the randomized trial comparing Mepilex Border Post-Op and Aquacel Surgical dressings in hip and knee arthroplasty.4 Both studies highlight Mepilex Border Post-Op's superior ease of application and removal, enhanced patient comfort, and reduced pain during dressing changes. However, our study extends these findings by including traditional dressings in the comparison, demonstrating Mepilex Border Post-Op's consistent superiority across broader parameters like exudate management and surgical site complication rates. This provides a more comprehensive perspective on the clinical advantages of advanced dressings.
Patients in Group C (Mepilex Border Post-Op®) reported significantly higher comfort levels and lower pain during dressing changes compared to the other groups. This suggests that advanced dressings can greatly enhance the patient experience by minimising discomfort and pain 10. Our findings are also in consonance with the randomized trial comparing four wound dressings, including Mepilex Border, in total knee arthroplasty.11 Both studies underscore Mepilex Border's superior performance in minimising wound complications, patient discomfort, and dressing renewals. While their study highlights cost considerations and ease of application, our research broadens the scope by assessing Mepilex Border's superiority over traditional and other advanced dressings across broader parameters such as exudate management, surgical site complications, and nurses' ease of use, providing a more holistic evaluation of its clinical utility. These findings align with previous studies that highlighted the benefits of advanced dressings in maintaining a moist wound environment conducive to healing.3
The study also demonstrated that Mepilex Border Post-Op® dressings were the easiest to apply and remove, as rated by nurses. This ease of use can streamline the dressing change process, save time for healthcare providers, and reduce the risk of complications arising from improper application.12 These practical benefits can lead to more efficient use of healthcare resources and lower costs associated with extended hospital stays or additional treatments for dressing-related complications. These results are supported by other studies that emphasize the operational efficiency of advanced dressings.4 Mepilex Border Post-Op® contains hydrophilic foam layers that enhance absorption, and its silicone adhesive reduces skin trauma, distinguishing it from traditional gauze and other advanced dressings.
Our study complements findings from the prospective investigation comparing Mepilex Border Post-Op with conventional dressings in hip and knee replacements.13 Both studies emphasize Mepilex Border's ability to reduce complications like blistering (0 % in their study) and the associated healthcare costs due to fewer dressing changes. Our study adds value by evaluating a broader range of outcomes, including pain reduction, exudate management, and patient comfort over multiple time points, providing a more comprehensive analysis of Mepilex Border's clinical benefits compared to both the traditional and the advanced dressings.
Mepilex Border Post-Op® dressings were found to be more effective in managing exudate, with fewer instances of high exudate levels compared to the other groups. Proper exudate management is essential for maintaining optimal wound moisture levels, which is crucial for promoting healing and preventing complications such as maceration and infection.14 By effectively managing exudate, advanced dressings can create a more conducive environment for wound healing, potentially reducing the incidence of surgical site infections and other complications.15 It is noteworthy that while Mepilex Border Post-Op® demonstrated the best overall outcomes, other advanced dressings like Opsite Post-Op also performed well in the aspects such as ease of application, highlighting the need for individualised dressing selection.
The observed trend toward reduced complications at day 14 in the Mepilex group, while not statistically significant (p = 0.08), aligns with the dressing's superior performance in other parameters, such as comfort, ease of application, and exudate management. These trends, though preliminary, are clinically meaningful and warrant further investigation in larger studies with extended follow-up periods. Highlighting trends in clinical outcomes is essential as they may indicate areas where advanced dressings could provide long-term benefits beyond immediate postoperative care.16
Patients in Group C reported the highest satisfaction levels, which is a critical factor in overall patient care and recovery. High patient satisfaction can lead to better adherence to post-operative care protocols and improved clinical outcomes16. Additionally, Mepilex Border Post-Op® dressings demonstrated superior integrity and adherence, reducing the risk of dressings peeling off or causing skin irritation. This reliability is essential for maintaining a sterile wound environment and supporting continuous healing.17
Based on the study's findings, it is recommended that healthcare providers in orthopaedic and other surgical settings adopt advanced dressings like Mepilex Border Post-Op® for post-operative wound care. These dressings enhance patient outcomes and improve operational efficiency along with resource utilisation. Ongoing education and training for healthcare providers on the benefits and proper use of advanced dressings can further optimise patient care and recovery. The reduced pain scores and superior exudate management associated with Mepilex Border Post-Op® could lower overall healthcare costs by reducing the need for frequent dressing changes and additional interventions.
Our study showcases several strengths that underscore its relevance and reliability. Firstly, the robust methodology, characterised by a randomized controlled design, minimises selection and allocation biases, ensuring validity in findings. This design, paired with a single-centre setting, provides a controlled environment that enhances consistency in protocol application and data collection. Additionally, the comprehensive measurement of outcomes—including patient comfort, pain levels, ease of dressing application and removal, and exudate management—provides a holistic view of dressing efficacy, which is directly relevant to clinical practice.
The study also introduces innovative comparisons, such as evaluating Mepilex Border Post-Op®, contributing valuable insights into the comparative effectiveness of advanced dressings. This is crucial, given the ongoing need for enhanced post-operative care solutions in orthopaedic settings. The employment of advanced statistical methods like ANOVA, Kruskal-Wallis, and multivariate analysis ensures robust findings, accounting for potential confounders and substantiating the study's conclusions. Moreover, the operational and clinical implications of these findings are significant. Demonstrating that advanced dressings can improve patient comfort and reduce pain, while also being easy to use, supports potential changes in post-operative care protocols. These benefits suggest that advanced dressings can improve patient outcomes and optimise resource utilisation in healthcare settings.
While this study provides valuable insights, it has several limitations. Firstly, the follow-up period of 14 days may be too short to capture all relevant complications, such as late-onset surgical site infections. Future studies should include longer follow-up periods to provide a more comprehensive assessment of the dressings' efficacy over time. Secondly, though this study provides valuable insights, its single-centre design may limit the generalizability of findings. Future multicenter trials are recommended to validate these results across diverse populations and clinical settings. Thirdly, the open-label design of the study could introduce bias, especially in subjective measures like patient comfort and pain levels. While efforts were made to minimise potential bias, blinding outcome assessors to the type of dressing could further reduce bias in future studies. Next, certain preoperative and intraoperative factors such as duration of surgery, blood transfusion, and intraoperative soft tissue handling, which may influence SSI rates, were not formally controlled in this study. Future research should include these variables for a more comprehensive analysis. Finally, although adjustments for multiple comparisons were applied, some differences between dressings were not statistically significant, indicating a need for larger sample sizes to capture more conclusive data. By addressing these limitations in future research, the evidence supporting the use of advanced wound dressings in post-operative care can be strengthened, leading to improved patient outcomes and more efficient healthcare delivery.
Our study indicates that Mepilex Border Post-Op® dressings offer several advantages over traditional gauze-based dressings and other advanced dressings in post-operative orthopaedic care. Patients using Mepilex Border Post-Op® reported significantly higher comfort levels and lower pain during dressing changes. Nurses also rated these dressings as the easiest to apply and remove, which can streamline the dressing change process, save time for healthcare providers, and reduce the risk of complications arising from improper application. Furthermore, Mepilex Border Post-Op® demonstrated superior exudate management, effectively maintaining optimal wound moisture levels, which is crucial for promoting healing and preventing complications such as maceration and infection. Patient satisfaction was highest among those using Mepilex Border Post-Op®, which is critical for adherence to post-operative care protocols and overall clinical outcomes.
While the findings are promising, some differences between Mepilex Border Post-Op® and other dressings were not statistically significant, indicating a need for further research with larger sample sizes and longer follow-up periods to capture late-onset complications such as surgical site infections. Additionally, the single-centre design of our study warrants caution in the interpretation of results. Future studies should include multicentre trials with a larger sample size to validate these findings across diverse clinical settings. Despite these limitations, our study provides strong evidence supporting the use of Mepilex Border Post-Op® dressings in post-operative orthopaedic care, highlighting their role in enhancing patient comfort, reducing pain, improving operational efficiency, and ensuring better wound management outcomes.
Patient consent
Written informed consent has been obtained from the patient or guardian for participation and publication.
Consent to participate
Informed consent was obtained from all individual participants included in the study.
Consent to publish
The authors affirm that human research participants provided informed consent for publication.
Ethics approval
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Army Hospital (Research & Referral) (Date Aug 22, 2022 No 86/2022).
Ethical clearance
This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Army Hospital (Research & Referral) (Date Aug 22, 2022 No 86/2022). This study was conducted following the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All procedures performed in studies involving human participants were approved by the Institutional Ethics Committee (IEC), with IEC approval number 86/2022. The trial was registered with ClinicalTrials.gov with ID NCT06540040. Informed consent was obtained from all individual participants included in the study. No animal studies were carried out by the authors for this article.
Author contribution
NS: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well. M: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well. AG: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well. MG: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well. MK: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well. MK: All authors contributed to the study conception and design. Material preparation, data collection and Formal analysis were performed by, The first draft of the manuscript was written by all authors combined and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript after revision as well.
Funding
The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.
Declaration of competing interest
The authors declare that they have no competing interests to declare.
Acknowledgements
We sincerely acknowledge the invaluable guidance and support provided by Col Dechen Choden, Principal, and Lt Col Sunita, Tutor, of the College of Nursing at Army Hospital (R&R) in the successful conduct of this work.
References
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