The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown (NCT03929224), a randomized phase 4 study. The primary outcome is Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome).

2. Clinical Question

The primary outcome concerns the appearance of skin around the bone-anchored hearing aid abutment. The Holgers Classification runs from Grade 0, indicating no reaction, to Grade 4, indicating an extensive soft-tissue reaction and a worse outcome. Photographs were taken at 1 week, 3 months and 6 months post-op, then evaluated by 5 separate, blinded Otolaryngologists. The registry also identifies oral antibiotic use and pain at the abutment site as secondary outcomes.

The question is therefore about comparative postoperative skin findings under the two stated care regimens, not about hearing outcomes or a general comparison of all uses of honey and bacitracin. The registry record does not report numerical results for the primary outcome, oral antibiotic use or pain. It consequently does not establish the direction or size of any difference between the groups.

3. Trial Design

The registry describes a randomized, parallel-group trial with no masking. It is listed as Phase 4 and as completed. The enrollment is 17. The record gives a start date of 2018-10-25 and a primary completion date of 2020-09-01. Henry Ford Health System is listed as the sponsor.

Participants were assigned to medicinal honey or bacitracin. The descriptions specify the application at surgery and the postoperative instructions: the healing cap was removed on postoperative day 7, followed by daily application of the assigned ointment for 2 weeks. These are the regimens as described in the registry; further details about adherence, treatment changes or other aspects of care are not reported in the registry record.

Although the trial lists no masking, the primary outcome description says that photographs were randomized for evaluation and assessed by 5 separate, blinded Otolaryngologists. This describes blinding of the photograph evaluators; it does not change the registry’s designation of the trial as having no masking. The record does not state whether participants or treating staff were aware of assignment beyond that overall designation.

The outcome photographs were taken at 1 week, 3 months and 6 months post-op. The registry lists a mean and standard deviation as the primary outcome summary, with the measure expressed in grades. It does not report the allocation procedure, the intended number of participants, the sample-size justification, or a detailed statistical analysis plan. The enrollment count should therefore be read as the number enrolled, not as evidence about the design assumptions or the number included in any particular outcome analysis.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Patients qualified for BAHI: single-sided deafness, conductive or mixed hearing loss on audiometric testing.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Patients who qualified for BAHI for single-sided deafness, conductive or mixed hearing loss on audiometric testing.

6. Primary Endpoint

The registry lists the primary outcome as Holgers Classification of Skin Reactions at the Surgical Site Graded 0 (no Reaction) to 4 (Worse Outcome), measured over Photographs of the surgical site were taken at 1 week, 3 months and 6 months post-op..

The primary endpoint is the Holgers Classification of skin reactions at the surgical site. It describes the appearance and severity of reaction around the implant: Grade 0 is no reaction; Grade 1 is reddish discoloration; Grade 2 is a red and moist surface; Grade 3 is formation of granulation tissue; and Grade 4 is an extensive soft-tissue reaction. A higher grade represents a worse outcome. The registry states that the Holgers score was not recorded before or on the day of surgery.

The endpoint was assessed from photographs taken at 1 week, 3 months and 6 months post-op. Five separate, blinded Otolaryngologists evaluated the photographs, which were randomized for evaluation. This approach uses visual assessment of the surgical site rather than a patient-reported symptom alone, and the grade categories convey progressively more pronounced reactions as defined in the record.

The registry lists the outcome as a mean with standard deviation. Because Holgers grades are ordered categories, a mean treats differences between adjacent grades as though they were numerically comparable. That is a statistical convention, not proof that the clinical distance between each grade is identical. The record gives no grade distributions or mean estimates, so the observed skin-reaction patterns and their precision cannot be described from the registry information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are tools for turning observations into estimates of group differences and for describing uncertainty. The registry identifies the design and outcome definition, but it does not report the analysis used for the primary endpoint. The concepts below are general explanations of how such data may be considered; they are not descriptions of an analysis confirmed in the registry record.

What does randomization contribute?

In general, random assignment is intended to make treatment groups comparable in expectation with respect to both measured and unmeasured characteristics. It does not guarantee that a small set of enrolled participants will have identical characteristics in each group. It also does not, by itself, ensure that every participant contributes an outcome measurement or that the groups are analyzed according to their original assignments. The registry identifies the trial as randomized, but allocation methods, concealment details and analysis population are not reported in the registry record.

For a randomized comparison, an analysis should make clear which participants and observations are included and how assignment is handled. The registry does not say whether the primary analysis followed original assignment, used only participants with evaluable photographs, or used another approach. That information is important because excluding participants after assignment can affect the comparability that randomization was intended to establish.

How should a mean grade be understood?

The Holgers Classification is an ordered scale from Grade 0 to Grade 4. Ordered categories have a natural rank, but the spacing between adjacent categories is not necessarily a fixed quantitative distance. Reporting a mean treats the grade labels as numerical values and averages them. This can be a useful summary, but it may not fully describe the pattern of reactions. Different distributions across categories can yield similar means, and the mean alone does not show how many observations were in each grade.

A standard deviation describes spread around a mean when a numerical summary is used. It does not show the full category distribution, and it does not by itself describe uncertainty in the estimated group mean. A confidence interval, when reported, is designed to describe uncertainty around an estimate under the assumptions of the analysis. It is not a range that contains a fixed proportion of individual participants’ outcomes, nor does it establish that an effect is clinically important. No group means, standard deviations or confidence intervals for Holgers grades are reported in the registry record.

Why do repeated assessment times matter?

The primary outcome description includes photographs at 1 week, 3 months and 6 months post-op. Repeated measurements can show whether group patterns differ over follow-up, but observations from the same participant are generally related rather than independent. An analysis that uses multiple measurements may need to account for that within-participant relationship. Alternatively, a report may present a separate comparison at each scheduled time. The registry does not describe which strategy was used, and it does not report time-specific outcome estimates.

Looking at multiple times and multiple grades also creates a multiplicity issue: the more comparisons considered, the greater the chance that at least one will appear unusual by chance alone. There are established approaches for managing this, including prespecifying a primary comparison or adjusting interpretation for multiple tests. The registry does not report a multiplicity strategy or a single reduced comparison for this primary outcome. No particular approach should be attributed to the trial.

What does over-dispersion mean in general?

Over-dispersion occurs when observed variability exceeds what a statistical model assumes. In general, a model that understates variability can produce uncertainty estimates that are too narrow. For an ordered grade outcome, the distribution across categories and any clustering of judgments may affect how well a chosen model represents the data. This is a general consideration, not a reported feature of these trial data. The registry does not provide the outcome distribution or model details needed to assess it.

What can a sample-size illustration establish?

A planning illustration is not a result from the trial and is not observed power. The record describes planning assumptions based on a fraction of an observed effect, a two-sided significance level of 0.05, equal allocation and a normal approximation. Those are stated as illustration assumptions, not as the trial’s own design justification. The registry does not report the effect estimates needed to interpret a particular planning row, and no trial-specific sample-size rationale is reported. A planning calculation cannot make an unreported primary result more precise or recover the missing group estimates.

In general, statistical significance and effect size answer different questions. A p-value, if reported, describes how incompatible data are with a specified null model under its assumptions; it does not quantify the size or importance of a difference. An effect estimate and its confidence interval are needed to describe magnitude and precision. Neither is reported for the primary outcome in the registry record. Without those results and the analysis details, statistical evidence for a group difference cannot be evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at 1 week, 3 months and 6 months post-op and uses Holgers grades from 0 to 4. Multiple assessment times and categories create choices about which comparisons to emphasize and how to account for repeated observations and multiple testing. The registry record says the primary outcome has several categories or time points and is not reduced to one comparison. It does not report a multiplicity adjustment, a prespecified contrast or the method used to handle repeated observations.

Missing outcome data are also relevant because the endpoint depends on photographs being available and evaluable. The registry describes the planned photographic assessments but does not report how many participants had usable photographs at each time, whether any assessments were missed, or how missing observations were handled. No imputation method or sensitivity analysis for missing data is reported in the registry record. It is therefore not possible to determine whether the available outcome observations represent all enrolled participants equally across groups.

The registry record does not identify the primary analysis population or state whether participants were analyzed according to original assignment. It does not report exclusions after randomization, adherence to the assigned ointment regimen, or a per-protocol analysis. The enrollment count should not be assumed to equal the number contributing to every endpoint or time point.

The record identifies secondary outcomes for oral antibiotic use and pain at the abutment site, but it does not report their results or how multiplicity across primary and secondary outcomes was addressed. A statistical analysis plan and any interim analyses are not reported in the registry record. These omissions prevent a full assessment of prespecification, missing-data handling and the complete family of statistical comparisons.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports no serious adverse events among 8 participants at risk in the bacitracin group and none among 9 participants at risk in the medicinal honey group. It also reports zero deaths in each group. For other adverse events, the record reports none among the 8 participants at risk in the bacitracin group and none among the 9 participants at risk in the medicinal honey group. No top serious adverse event terms are listed.

These are counts for the participants and safety information recorded in the registry. They should not be read as proof that an adverse event cannot occur, or as a precise comparison of safety between regimens. With a total enrollment of 17, the record describes a limited number of participants; the safety counts alone cannot characterize uncommon events. The registry does not provide additional event descriptions, exposure time, or details about how adverse events were collected. The absence of listed serious events is therefore a narrow description of the posted safety figures, not a comprehensive estimate of risk.

12. What the Result Does, and Does Not, Mean

The record documents a completed randomized, parallel-group comparison of medicinal honey and bacitracin after bone-anchored hearing aid surgery. It describes how each regimen was used, how the surgical site was photographed and graded, and which secondary outcomes were planned. It also reports the serious adverse event and other adverse event counts for each group.

It does not report numerical primary outcome results. There are no group estimates for the Holgers Classification, no category counts, and no measures of uncertainty or statistical test results. As a result, the registry record cannot establish whether the observed skin reactions differed, how large any difference was, or how precisely it was estimated. The same limitation applies to the secondary outcomes of oral antibiotic use and pain, for which numerical results are not reported.

The descriptions of the grade scale and blinded photograph evaluators help explain how the primary outcome was defined and assessed. They do not supply the missing outcome data. Likewise, randomized assignment and completed status do not establish that one regimen led to better results. A treatment comparison requires observed results and an appropriate analysis, not design information alone.

The posted safety counts show that no serious or other adverse events and no deaths were recorded in either group in the registry entry. Those counts should be interpreted in the context of the small enrollment and limited details about event collection. They do not support a broad assurance about safety.

Thus, the record is informative about the trial question and its methods as registered, but not about the comparative outcome estimates. Any conclusion beyond those descriptions would require results and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises statistical issues that commonly arise when clinical outcomes are measured as ordered grades over repeated visits. The Holgers Classification has clinically described categories, while the registry lists a mean and standard deviation as the summary. Such summaries can be concise, but they do not reveal the distribution across grades. Reporting category counts alongside a mean could make the observed pattern easier to understand; the registry does not report those counts.

Assessment at 1 week, 3 months and 6 months post-op also makes the choice of analysis consequential. Separate comparisons at each visit answer different questions from a model that considers follow-up jointly. Repeated measurements on the same participants are related, and multiple looks across visits can complicate interpretation. The registry identifies the time points but does not state the analysis strategy or a multiplicity approach.

The description that photographs were randomized for evaluation and assessed by 5 separate, blinded Otolaryngologists is relevant to outcome ascertainment. It indicates that the evaluators were blinded, even though the trial is listed as having no masking. The record does not describe how differences between evaluators were combined or whether agreement was assessed. Those details would help readers understand the reliability of a graded photographic endpoint.

Most importantly, the registry illustrates a distinction between a registered design and an interpretable result. Randomization and a defined outcome are valuable design features, but estimating a comparative effect also requires group data, uncertainty estimates and a transparent analysis. Those numerical primary results are not reported. This limits what can be learned statistically from the registry entry, even though the trial question and assessment schedule are clearly described.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

A central limitation of the available record is that it does not report numerical results for the primary endpoint or either listed secondary outcome. Without group-level Holgers grades, means, standard deviations or uncertainty estimates, the comparative effect cannot be evaluated. The outcome has multiple time points and categories, but no time-specific or category-specific results are reported.

The registry states that the Holgers score was not recorded before or on the day of surgery. There is therefore no baseline Holgers measurement in the stated outcome description with which to characterize preoperative skin status or assess change from baseline. The record also does not report the number of photographs collected or judged evaluable at each follow-up assessment.

Although evaluators are described as blinded, the trial itself is listed as having no masking. The registry does not provide additional details about allocation concealment, adherence, treatment changes, outcome adjudication or the handling of disagreement among evaluators. It also does not state how the ordered grades were analyzed beyond listing the mean and standard deviation.

Enrollment was 17, but the record does not report the number included in each primary outcome analysis or the analysis population. Missing-data methods, a trial-specific sample-size rationale, a statistical analysis plan, multiplicity handling and interim analyses are not reported in the registry record. These limitations constrain assessment of both the statistical methods and the precision of the results.

The safety entry provides counts but little context about event definitions or collection. Those counts do not replace detailed safety reporting. Overall, the registry describes the trial question and procedures more fully than it reports the results needed for a comparative interpretation.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Use of Medical Grade Honey in the Prevention of Bone Anchored Hearing Aid Associated Skin Breakdown — NCT03929224.
• Registry record last updated 2026-01-07; status last verified 2022-08.
• Results first posted 2022-08-30.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT03929224 is a completed Phase 4 randomized, parallel-group trial sponsored by Henry Ford Health System. The registry lists enrollment of 17, a start date of 2018-10-25 and a primary completion date of 2020-09-01. It compares postoperative medicinal honey with bacitracin after bone-anchored hearing aid surgery and lists no masking.

The primary outcome is the Holgers Classification of skin reactions, assessed from photographs taken at 1 week, 3 months and 6 months post-op. The record describes evaluation by 5 separate, blinded Otolaryngologists and lists mean and standard deviation as the outcome summary. Secondary outcomes are oral antibiotic use and pain at the abutment site.

Numerical results for the primary and secondary outcomes, analysis details and missing-data methods are not reported in the registry record. The safety entry reports no serious or other adverse events and no deaths in either group.