Comparative Analysis of Ear-packing Materials in Postoperative Recovery: Outcomes and Efficacy

Study Design and Setting

This was a prospective, comparative study conducted at a tertiary care hospital from January 2020 to December 2021. Although the study employed randomization in the assignment of participants to different ear-packing materials, it was not registered as a randomized controlled trial in any clinical trials registry. The design and reporting of the study were guided by principles such as those in the Consolidated Standards of Reporting Trials (CONSORT) guidelines, ensuring rigor and transparency in the methodology and results presentation.

Participants

The study enrolled 100 patients aged 18 years or older who had undergone ear surgeries for conditions such as chronic otitis media, cholesteatoma, and tympanoplasty. Exclusion criteria included a history of allergic reactions to ear-packing materials and significant comorbidities that might influence the healing process.

Interventions

Participants were randomized into one of four intervention groups based on the type of ear-packing material:

• Group I: Absorbable gelatine sponge.

• Group II: Silicone-based material.

• Group III: Polyvinyl alcohol sponge.

• Group IV: Chitosan-based material.

The duration of ear packing was also randomized, with participants receiving packing for either 7, 14, or 21 days.

Randomization and Blinding

A computer-generated random sequence was used for participant allocation to intervention groups. Allocation concealment was ensured using sealed, opaque envelopes. Outcome assessors and participants were blinded to the intervention groups, while surgeons were not due to the nature of the intervention.

Outcomes

The primary outcome was the incidence of postoperative complications, specifically categorized as infection, granulation tissue formation, and persistent otorrhea. Secondary outcomes included adjuvant therapies, pain levels [visual analog scale (VAS)], patient satisfaction (standardized survey), quality of life assessments [hearing handicap inventory for adults (HHIA) and Tinnitus Handicap Inventory (THI) and packing durations.

Long-term Follow-up

Participants were monitored for 1-year postsurgery to evaluate long-term outcomes. This included assessing hearing improvement, recurrence of ear-related issues, and the need for additional surgical interventions. Data on these outcomes were collected during regular follow-up appointments or through phone interviews conducted by trained research staff.

Sample Size Determination

The sample size of 100 patients was determined based on a power analysis, considering an expected dropout rate, the effect size from previous studies, and a desired power of 0.8 at a significance level of 0.05.

Statistical Methods

Baseline characteristics were summarized using descriptive statistics. Outcome comparisons were made using Chi-square tests, one-way ANOVA, Kruskal–Wallis tests, and repeated-measures ANOVA, with a significance threshold set at p < 0.05. The software SPSS, version 25.0, was used for all analyses.

Cost-effectiveness Analysis

A cost-effectiveness analysis was incorporated, comparing the costs of different ear-packing materials against their associated postoperative outcomes.

Ethical Considerations

The study was conducted in compliance with the Declaration of Helsinki and received approval from the Institutional Review Board of the hospital. Informed consent was obtained from all participants.

Participant Flow and Recruitment

The study retained all 100 participants, with demographic characteristics evenly distributed across the intervention groups. The mean age was 42.3 years (SD: 12.6), and females comprised 56% of participants. The similarity in the distribution of ear surgery types and demographic factors such as age and gender across groups (p > 0.05) suggests effective randomization, allowing for a balanced comparison of the outcomes associated with each ear-packing material.

Baseline Data

In this study, surgeons were classified based on the Dreyfus model of skill acquisition, encompassing competent, proficient, and expert levels. Competent surgeons manage routine procedures and understand overall objectives, proficient surgeons bring a holistic view and deeper understanding to surgical situations, and expert surgeons display a highly skilled, intuitive grasp of complex surgical scenarios. This classification was utilized to ensure that the impact of various ear-packing materials on postoperative outcomes was analyzed across a spectrum of surgical expertise, acknowledging its crucial role in patient recovery and procedural success.

Outcomes and Estimation

• Postoperative complications: Significant differences were found in the incidence of postoperative complications among the four groups (p < 0.05). The lowest complication rate (8%) was observed in group I (absorbable gelatine sponge), followed by group II (silicone-based material, 16%), and group III (PVA sponge, 20%). Group IV (chitosan-based material) had the highest complication rate (32%). The most frequently observed complications were infection, granulation tissue formation, and persistent otorrhea.

• Adjuvant therapies: In the study, adjuvant therapies such as topical antibiotics and corticosteroids were administered variably across different groups, reflecting a practice where treatments are tailored to each patient’s unique clinical needs. This variation was not influenced by the type of ear-packing material but was a result of individual patient care decisions made by physicians. The absorbable gelatine sponge group, Group I, observed the highest percentage of patients receiving these therapies, followed by groups II, III, and IV.

  To ensure the integrity of the study’s findings, statistical analyses were meticulously conducted to adjust for the potential confounding effects of the differential use of adjuvant therapies. This approach was crucial for isolating the independent effects of the ear-packing materials on postoperative outcomes. It allowed accurate assessment of the efficacy of each material, particularly the absorbable gelatine sponge, independent of the influence of adjuvant therapies. Future studies might benefit from a standardized approach to adjuvant therapy administration across all experimental groups, which would facilitate a more direct comparison of the ear-packing materials themselves.

• Pain levels: The study analyzed the mean pain levels, measured using the VAS, for each group and packing duration. The results showed that there were no significant differences in pain levels across the four groups and three packing durations (p > 0.05). The mean VAS scores ranged from 3.2 to 3.8, indicating mild to moderate pain levels in all groups (Table 1).

• Quality of life: Quality of life assessments using validated questionnaires revealed significant improvements in hearing and overall well-being in all groups, with group I (absorbable gelatine sponge) showing the most notable improvements (Fig. 1).

• Patient satisfaction: Patient satisfaction scores were significantly different among the four groups (p < 0.05), with group I (absorbable gelatine sponge) having the highest mean score (8.4 out of 10) and group IV (chitosan-based material) having the lowest mean score (6.2) (Table 2).

• Packing duration: The study revealed that packing duration significantly affected complication rates and patient satisfaction. The 14-day duration had the lowest complication rates and highest satisfaction scores, while the 7-day and 21-day durations had higher complication rates and lower satisfaction scores. The differences were statistically significant, emphasizing the importance of selecting an appropriate packing duration to achieve better outcomes (Table 3).

• Long-term outcomes: The long-term follow-up outcomes for each group were evaluated, with a specific focus on the recurrence of ear-related issues and the need for additional surgical interventions. The findings revealed that group I (absorbable gelatine sponge) demonstrated the lowest rates of recurrent ear issues and additional surgical interventions, indicating superior long-term outcomes compared to the other groups (Figs 2 to 6).

Economic Data

The cost-effectiveness analysis highlighted the absorbable gelatine sponge (group I) as providing the most favorable balance between cost and positive postoperative outcomes, aligning with the trends in healthcare toward economic efficiency without compromising patient care quality.

Interpretation of Findings

This study’s examination of various ear-packing materials provides crucial insights into their impact on postoperative outcomes, offering both confirmations and challenges to existing literature. The absorbable gelatine sponge (group I) showed the most favorable results, consistent with the findings of Roland and Stroman (2002), who emphasized the importance of material selection in optimizing surgical outcomes.⁹ This correlation highlights the significance of choosing suitable packing materials to enhance patient recovery postsurgery.

On the contrary, the higher incidence of complications observed with chitosan-based materials in group IV deviates from the established biocompatibility of chitosan reported in earlier research.¹⁰ This unexpected finding suggests that clinical outcomes of ear-packing materials might vary, influenced by factors like patient-specific responses or surgical context, which are not fully captured in material property studies alone.

Despite comparable pain levels across all groups as indicated by the VAS, the study observed significant differences in patient satisfaction. This suggests that factors beyond pain, such as the overall quality of healing and auditory function improvements, play a substantial role in shaping the patient experience.¹¹ The improvements in quality of life, especially pronounced in group I, align with previous studies like Shen et al. (2011) that discuss the benefits of specific packing materials in enhancing postsurgical hearing recovery.⁴ These enhancements indicate the critical role of packing materials not only in immediate healing but also in contributing to long-term patient benefits.

Comparative Analysis with Other Studies

The study’s findings on patient satisfaction and long-term benefits offer a new perspective in the context of ear surgery. While the consistency in pain levels challenges the assumptions of material-induced discomfort suggested by previous studies, the variations in patient satisfaction highlight the multifaceted nature of patient recovery. This underscores the need for a comprehensive evaluation of ear-packing materials, considering patient-centric outcomes as emphasized in the study of Carr et al.¹¹

Furthermore, the long-term advantages associated with the absorbable gelatine sponge suggest a need to focus on sustained outcomes in material selection. This aspect, often under-emphasized in studies such as Borgstein et al., which focused mainly on immediate postoperative effects, is crucial for a holistic approach to patient care in otology.⁶

The cost-effectiveness analysis of the study, highlighting the absorbable gelatine sponge’s balance between cost and efficacy, aligns with the value-based care approach in healthcare, as suggested by Neumann and Cohen.¹² This approach emphasizes the importance of integrating clinical efficacy with economic efficiency in healthcare decision making.

In conclusion, this study enriches the existing literature by providing comparative insights into the efficacy of different ear-packing materials and underscores the importance of aligning clinical choices with both immediate and long-term patient outcomes. Future research should continue to explore these relationships, particularly focusing on patient-centered outcomes and the long-term efficacy of different materials.

Clinical Implications

The results of this study have important implications for the field of otology and its use in clinical practice. The research evidence reported on the clinical efficacy and cost-efficiency of the absorbable gelatine sponge suggests that it could serve as an ideal choice for postsurgical ear packing. It is important for healthcare professionals to understand the potential constraints associated with materials based on chitosan. The study highlights the importance of considering various patient-specific qualities, the expertise of the surgeon, and the combined impacts of adjuvant treatments when formulating a postoperative care plan. Considering the essential role of ear-packing materials in influencing postoperative outcomes. these findings can provide valuable guidance to clinicians in making decisions that optimize patient recuperation and long-term satisfaction.

Limitations and Future Directions

This study offers important insights into postoperative ear care, but it is essential to recognize its limitations for a complete understanding. The study’s sample size was limited to 100 participants, which might not fully capture broader patient variability. Additionally, the one-year follow-up period may not encompass the long-term effects of different ear-packing materials. Variations in surgeon expertise and the study being conducted in a single location also introduce factors that could influence the outcomes. Future research could benefit from larger patient cohorts, extended follow-up durations, trials across multiple centers, exploration of new ear-packing materials, and a comprehensive cost-benefit analysis that includes long-term financial impacts. These steps would help validate and expand upon our findings, enhancing their applicability in diverse clinical settings.