Mastectomy Flap Temperature Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Mastectomy Flap Temperature Study (NCT05395936), a na na study. The primary outcome is Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery.

2. Clinical Question

The central purpose is to collect prospective temperature measurements and create a database that may support evaluation of research questions and quality-improvement objectives related to breast surgery care. That aim is distinct from testing whether one intervention improves a clinical outcome relative to another. The registered study does not define a control arm, and the primary outcome concerns participation rather than a patient health outcome.

The practical questions are therefore descriptive: how many eligible women were approached, how many agreed to participate, and what temperature observations were collected during surgery? The registry gives the first two counts, but does not provide the resulting temperature values or a detailed account of the collected dataset. It also does not report a temperature threshold, a clinically important difference, or a specific clinical decision that the measurements were intended to guide.

3. Trial Design

This is a single-group study of intraoperative data collection, registered as NCT05395936 under the title Mastectomy Flap Temperature Study. Wake Forest University Health Sciences is the sponsor. The record lists the phase as NA, allocation as NA, and masking as none. These entries are consistent with a measurement and data-collection study rather than a masked randomized comparison. No distinct control group is described.

Participants scheduled for mastectomy, with or without breast reconstruction, were to have breast skin temperatures measured with a myocardial probe at different anatomical areas and at multiple time points during surgery. The registered interventions are Myocardial Probe Temperature Screen and Data Collection. The secondary outcome is described as change in mastectomy flap temperatures and core body temperatures. The registry lists 3 outcome measures and 1 analysis, but does not give the detailed results or analytic procedure for that analysis.

The record states that 22 eligible women were approached and 19 agreed to participate. Enrollment is recorded as 19. The study start date is 2022-09-29, and primary completion is recorded as 2024-03-17. Its status is terminated. The reason for termination, whether recruitment ended as planned, and whether any measurements were unavailable are not reported in the registry record.

The registry describes the study’s purpose as measuring tissue temperatures and generating a prospective database to enable evaluation of research questions and quality-improvement ideas concerning breast surgery care. This purpose does not establish that the study tested a treatment effect. Nor does the record describe a prespecified comparison between temperature measurement strategies, surgical approaches, or reconstruction groups. The protocol, detailed visit schedule, measurement calibration procedures, and statistical analysis plan are not reported in the registry record.

Because there is no randomized allocation or separate comparator, results should be read as observations from the participating group. They cannot establish how temperatures or outcomes would have differed under another approach. The registered design is useful for describing what measurements were intended and how many women agreed to participate, but the available record does not show the temperature data needed to characterize the observed measurements.

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: 22 eligible women were approached to participate, 19 agreed to participate in the study

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.

6. Primary Endpoint

The registry lists the primary outcome as Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery, measured over 90 days post surgery.

The primary outcome is titled Number of Women Consenting to Have Mastectomy Flap Temperatures Measured During Surgery. It is a count of participants, not a temperature change or a clinical outcome. The timeframe is listed as 90 days post surgery. The record states that 22 eligible women were approached and 19 agreed to participate.

The description says the outcome will be computed by dividing the total number of eligible women screened by the number of women who consent. That wording does not clearly match the title’s description of a number of women consenting: a count and a quotient are different kinds of summaries. The registry does not clarify this discrepancy or provide a reported endpoint value beyond the underlying approach and consent counts. No calculation should be inferred from the description.

A participation measure can describe whether eligible people were willing to join a measurement study. It may help readers understand recruitment and the feasibility of collecting intraoperative observations. It does not measure whether flap temperatures changed, whether temperature measurement affected care, or whether a clinical outcome improved.

The record also lists change in mastectomy flap temperatures and core body temperatures as a secondary outcome, but does not report those values, the specific summary used, or the time points at which change was assessed. The primary endpoint therefore characterizes participation as registered, while the temperature-focused question remains unanswered by the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary outcome count?

The primary outcome is framed as the number of women who consented to intraoperative mastectomy flap temperature measurement. A count describes how many participants meet a defined condition. In this case, the condition is consent to participate, rather than having a particular temperature value or experiencing a clinical event. The registry gives the underlying recruitment information: 22 eligible women were approached and 19 agreed to participate. It does not report a separately calculated endpoint result.

The outcome description also states that the measure will be computed by dividing the total number of eligible women screened by the number who consent. That description is not equivalent to a count and is not reconciled with the endpoint title in the record. Without clarification, a reader should not treat the title and the calculation wording as interchangeable. The reported counts can be described directly, but no additional consent statistic should be inferred.

What can a single-group design estimate?

A single-group design records observations in one participant group. Here, the registered plan is to measure temperatures during surgery. Such observations can describe the measurements made in the participating group, if the values and analytic details are reported. They do not, by themselves, estimate how those values would differ under a comparator condition. Allocation is listed as NA, and no control group is described, so the registry does not support a randomized between-group treatment-effect interpretation.

Masking is listed as none. For a measurement study, methods such as probe placement, measurement timing, device calibration, and assessor procedures can influence how reproducible data are. The registry describes anatomical areas and multiple time points but does not report detailed procedures for these elements. Their absence from the record limits assessment of measurement consistency; it does not show that procedures were inadequate.

How should repeated temperature observations be understood?

General statistical explanation: observations taken from the same participant can be related to one another. Measurements at different anatomical sites or times may share participant-specific features, so treating every observation as independent could understate uncertainty. Statistical methods for repeated measurements account for this dependence, but the appropriate approach depends on the data structure and the question being asked. The registry does not report the number of measurements per participant, the temperature summaries, or a model addressing within-participant dependence.

The listed secondary outcome concerns change in mastectomy flap temperatures and core body temperatures. To interpret change, readers would need to know which measurements were compared, how the change was summarized, and how missing measurements were handled. Those details and the numerical results are not reported in the registry record. No direction or magnitude of temperature change can therefore be described.

What do confidence intervals and p-values contribute?

General statistical explanation: a confidence interval describes a range of values compatible with a statistical estimate under a specified method and assumptions. Its width conveys precision; a narrow interval indicates greater precision than a wide interval for the same type of estimate. A p-value measures how unusual the observed data would be under a specified null model, assuming that model and its assumptions. Neither quantity establishes clinical importance on its own. The record does not report a confidence interval or p-value for the primary outcome, and no temperature-effect estimate is posted for which uncertainty could be assessed.

A count can be presented descriptively without a hypothesis test. If an inferential analysis were intended, its target population, sampling assumptions, and method would need to be specified. The registry does not report such a plan for the consent count. The listed analysis count alone does not identify the method, model, or estimand used.

What does the planning language establish?

The record includes a sample-size planning illustration described as being based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also states that the effect to detect is a stated fraction of the observed effect. This is planning language, not evidence that the study was designed or conducted as a two-arm trial. The registered study is single-group, and allocation is NA. No corresponding sample-size outputs are reported in the record, so no participant requirement can be quoted.

General statistical explanation: a planning calculation estimates how much information a future study might need under chosen assumptions. It is not an observed result, and a post-study sample-size illustration does not establish the actual design rationale. A calculation based on an observed effect can also depend on the stability and precision of that effect. No protocol sample-size justification, prespecified target effect, or planned power calculation is reported in the registry record. The illustration should not be described as observed power.

Over-dispersion is a general concern when count data vary more than a chosen probability model expects. If a model assumes less variability than the data contain, estimated uncertainty may be too small. Whether over-dispersion is relevant depends on the outcome and analysis. The posted record does not give a count model or dispersion estimate, so no claim about over-dispersion in this study is possible.

In short, the available record defines the study’s measurement intent and gives recruitment counts, but does not supply the temperature data, model specification, uncertainty estimates, or analysis details needed for a fuller statistical assessment. General principles explain what those methods would address; they cannot substitute for the study’s unreported results.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Intraoperative Data Collection Arm")
n      <- c(22)
events <- c(19)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Intraoperative Data Collection Arm  22  19  86.4  65.1  97.1  66.7  95.3  66.4  95.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 3 outcome measures and 1 analysis. It does not provide a detailed statistical analysis plan explaining how the outcomes were prioritized, whether multiple comparisons were planned, or whether any adjustment for multiplicity was used. The primary outcome is the consent count, and a secondary outcome concerns change in mastectomy flap and core body temperatures. The presence of several outcomes does not itself show that multiple hypothesis tests were conducted.

General statistical explanation: when several hypotheses are tested, the chance of at least one apparently unusual result can increase if each test is interpreted separately. An analysis plan can address this by identifying a primary endpoint and specifying how secondary analyses will be interpreted or adjusted. The registry record does not report such procedures. Since it does not post temperature results or inferential tests, there is no multiplicity-adjusted finding to interpret.

Missing-data methods are also not reported in the registry record. The study intended measurements at multiple anatomical areas and time points, but the record does not state whether all planned measurements were obtained, how incomplete measurements were handled, or whether participants were excluded from any analysis. The 19 participants who agreed to participate should not automatically be assumed to have complete data for every measure.

Analysis populations are not described beyond the recruitment counts and the single-group arm. The record does not specify whether the primary outcome used all eligible women approached, only consenting participants, or another defined population for analysis. It also does not report whether any participant withdrew or whether data were unavailable. These omissions limit assessment of selection, missingness, and the relation between enrolled participants and analyzed observations.

12. 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.

For the intraoperative data collection arm, the registry records 19 participants at risk for serious adverse events and 19 at risk for other adverse events. It lists 0 serious events, 0 other events, and 0 deaths. No serious-event terms are listed. These figures are the safety counts posted for the study, not an estimate of risk relative to another group.

The study has no separate comparator arm, so the figures cannot be used to compare adverse-event rates between groups. The registry record does not describe the adverse-event observation window, event definitions, collection procedures, or whether the counts cover all periods of participant follow-up. The primary outcome timeframe is 90 days post surgery, but that does not establish the safety observation window.

A zero count in a record means no events are listed in that category for the participants recorded as at risk. It does not establish that an event was impossible, nor does it describe unrecorded events or events outside the registry’s reporting scope. With no event-level detail or comparative analysis, the figures should be read narrowly as registry-reported counts.

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

The result that can be stated directly is that 22 eligible women were approached and 19 agreed to participate. This documents participation in a study designed to measure breast-skin temperatures during mastectomy surgery and to collect data relevant to later research and quality-improvement questions. It does not show what temperatures were observed, how they changed over time, or whether temperature measurements were associated with any clinical outcome.

The study is not registered as a randomized comparison. There is no separate control group against which to judge a difference in temperature, care, or patient outcome. The primary endpoint is about consent, not treatment efficacy. The registry also does not report an analyzed endpoint value, an estimate of uncertainty, or a test of a clinical hypothesis. Accordingly, the posted information does not establish benefit, lack of benefit, or harm from any treatment or care approach.

The listed adverse-event counts are 0 serious events, 0 other events, and 0 deaths among 19 participants at risk in the arm. These counts do not establish that there was no safety risk, particularly because event definitions and the safety observation window are not reported in the registry record. They should not be converted into a comparison or a broader claim about safety.

The status is terminated, but the reason is not reported in the registry record. This status does not tell readers whether the study stopped because of recruitment, operations, funding, data collection, or another reason. Nor does it establish whether all intended measurements were completed.

The value of the record is therefore limited but clear: it documents the planned measurement purpose, the single-group design, recruitment counts, and posted safety counts. The central temperature question remains unresolved in the posted results because temperature measurements and their statistical analysis are not reported. Interpretation beyond those descriptive details would require additional results or methods not present in the registry record.

14. Why This Trial Matters Statistically

Clinical measurement studies can help characterize what is recorded during care before investigators attempt to answer more specific research questions. This study’s stated purpose was to measure tissue temperatures and build a prospective database involving participants undergoing mastectomy, with or without breast reconstruction. That kind of data collection can be relevant to later research and quality-improvement work, but its statistical value depends on transparent measurement and analysis details.

The registry identifies an important distinction between the feasibility of collecting data and the clinical meaning of those data. The approach and consent counts describe participation. They do not establish whether temperature measurements are reproducible, whether patterns differ across anatomical areas or time points, or whether any pattern is clinically meaningful. Those questions require the temperature values, a clearly stated analysis, and uncertainty estimates.

The single-group design is also important. It can support description of measurements among participants, but it cannot on its own provide a randomized estimate of how a different intervention or care strategy would change those measurements. Readers should distinguish a prospective measurement database from a comparative clinical trial, even when the collected measurements may inform future hypotheses.

The record further illustrates why endpoint wording matters. The primary outcome title describes a count of consenting women, while the description refers to a quotient involving eligible women screened and women who consent. Clear alignment between an endpoint’s name, definition, analysis population, and reported value makes results easier to interpret. The registry does not resolve that mismatch or provide a calculated endpoint result.

Finally, the terminated status and absence of temperature results leave important questions open. The record still documents the study’s intent and the participation counts, but a fuller statistical interpretation would require outcome data, missing-data information, and an analysis description. These distinctions help prevent descriptive recruitment information from being mistaken for evidence about clinical effects.

15. 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.

The registry record does not report the measured breast-skin or core body temperatures, despite the study’s stated measurement purpose. It therefore does not support description of temperature levels, changes, variation, or relationships among anatomical sites and time points. The secondary outcome is named, but its numerical results and definition of change are not posted.

The primary endpoint has an ambiguity: its title describes a number of women consenting, while its description says to divide eligible women screened by women who consent. The record gives the approach and consent counts but does not explain how this stated calculation relates to the titled count. No separately reported endpoint value resolves the issue.

The record describes a single group, with no comparator, and does not report a detailed protocol or analysis plan. Measurement procedures beyond use of a myocardial probe at different anatomical breast areas and multiple time points are not described. Details such as calibration, exact measurement schedule, and handling of repeated observations are not reported in the registry record. Their absence limits evaluation of measurement consistency and statistical methods.

Participant characteristics beyond eligibility for the study are not reported. The record does not state whether all consenting participants contributed complete measurements, how missing data were handled, or which analysis population was used. The status is terminated, but the reason and implications for data completeness are not reported.

Safety counts are posted, but event definitions and the observation window are not described. The sample-size language is a planning illustration, not a report of the study’s actual design rationale, and no associated planning values are posted. Together, these limitations restrict interpretation to the stated purpose, recruitment counts, design description, and listed safety counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Mastectomy Flap Temperature Study — NCT05395936.
• Registry record last updated 2024-12-04; status last verified 2024-11.
• Results first posted 2024-12-04.
• 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.

19. Record Summary

NCT05395936, Mastectomy Flap Temperature Study, is a terminated single-group study sponsored by Wake Forest University Health Sciences. It was designed to measure breast skin temperatures with a myocardial probe at different anatomical areas and multiple points during surgery among participants undergoing mastectomy, with or without reconstruction. Masking is listed as none and allocation as NA.

The primary outcome concerns the number of women consenting to temperature measurement. The record states that 22 eligible women were approached and 19 agreed to participate. It also lists change in mastectomy flap temperatures and core body temperatures as a secondary outcome, but does not report temperature results or detailed statistical analyses. The reason for termination is not reported in the registry record.

The adverse-event record lists 0 serious events, 0 other events, and 0 deaths among 19 participants at risk. Those figures are registry counts, with no event terms listed and no detailed observation window reported.