Antibacterial-coated Sutures at Time of Cesarean: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Antibacterial-coated Sutures at Time of Cesarean (NCT03386240), a randomized phase 4 study. The primary outcome is Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections.

2. Clinical Question

The trial asks a comparative question about infection after cesarean delivery, not about a single infection type alone. Its primary endpoint combines endometritis, wound infection, and other post-cesarean infections. This matters because the study’s principal comparison is defined by whether a participant experienced any qualifying infection in that composite, rather than by one diagnosis considered separately.

The registry describes the coated and uncoated suture groups as using their respective materials exclusively throughout the procedure. The stated objective is to determine whether antibacterial-coated sutures reduce surgical site infection after cesarean delivery. That objective is not itself evidence that an effect was observed. The registry record does not report a primary-outcome comparison that would answer the question, so the clinical question remains unresolved by the results.

The trial record lists an enrollment of 1169. The posted safety groups contain 585 and 584 participants at risk, respectively, but those safety figures do not establish the number included in a primary-endpoint analysis. The analysis populations and the number with complete primary-outcome data are not reported in the registry record.

3. Trial Design

This was a Phase 4 randomized, parallel-group trial with triple masking. The registry lists an enrollment of 1169 and identifies The University of Texas Medical Branch, Galveston as the sponsor. The trial is marked terminated. The registry lists a start date of 2018-01-09 and a primary completion date of 2024-11-22. The reason for termination and the circumstances around it are not reported in the registry record.

One group used triclosan-coated Monocryl Plus, Vicryl Plus, and PDS Plus sutures throughout the procedure. The other used the equivalent uncoated Monocryl, Vicryl, and PDS sutures throughout. The registry identifies the allocation as randomized and the model as parallel. The particular randomization method, allocation concealment procedures, and the roles of the parties who were masked are not reported in the registry record.

The primary outcome was the number of participants with endometritis, wound infection, or another post-cesarean infection within 30 days following delivery. The registry also lists maternal deaths, wound hematoma or seroma, and puerperal fever as secondary outcomes. These outcomes represent distinct clinical events, and the registry record does not report how they were analyzed in relation to one another.

The registry lists five outcome measures but no analysis records. It does not report the trial’s statistical analysis plan, its planned sample-size justification, or any interim analyses. The status of terminated does not, by itself, explain why the trial ended or establish whether planned recruitment or follow-up was completed. Those details are not reported in the registry record.

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

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 Participants With Endometritis, Wound Infection, or Other Post-Cesarean Infections, measured over Within 30 days following delivery.

The primary endpoint counts participants with endometritis, wound infection, or another post-cesarean infection within 30 days following delivery. It is a participant-count outcome: a participant qualifies if an infection meeting the registry’s definitions occurs within the stated follow-up period. The endpoint is not a count of separate infection episodes.

The registry describes endometritis as requiring at least two specified signs without another identified cause. Wound infection includes superficial or deep incisional surgical site infection, such as cellulitis or purulent discharge, and may include necrotizing fasciitis. Wound hematoma, seroma, or wound breakdown alone, without signs of infection, does not qualify as an infection. Other infections include pelvic septic thrombosis or a radiologically confirmed abdominal or pelvic abscess.

In general, a composite endpoint can capture several clinically related outcomes in one comparison. Its interpretation depends on the component definitions and on which components occur; an overall composite result would not, on its own, show that every component changed in the same way. Here, the registry record does not report component counts or a primary comparative result, so it is not possible to describe which infections occurred or how the groups compared.

The endpoint’s follow-up window is within 30 days following delivery. How the investigators ascertained infections, handled participants without complete follow-up, or adjudicated uncertain cases is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the trial as randomized, triple-masked, and parallel-group. These terms describe features of design, but they do not give the full statistical methods. The allocation sequence, concealment procedures, masked roles, outcome-assessment procedures, and analysis plan are not reported in the registry record. The explanations below are general statistical context, not claims about methods this trial used.

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based process. When implemented and maintained appropriately, it can reduce systematic differences between groups at the start of a trial. It does not guarantee that the groups will be identical, and it cannot by itself prevent bias from missing outcomes, departures from assigned treatment, or differences in how outcomes are measured. The registry confirms randomized allocation but does not report the sequence-generation or concealment details needed to assess those processes.

What does a parallel-group design mean?

In general, a parallel-group trial compares groups assigned to different strategies, with participants remaining in their assigned group for the study’s comparisons. Here, the registry describes a parallel model and two suture strategies. The way the investigators handled any changes in assigned materials, protocol deviations, or crossovers is not reported in the registry record. No assumptions about those events should be made from the design label alone.

How should the endpoint count be understood?

The primary outcome is a binary participant-level endpoint: each participant either meets the composite infection definition within the stated follow-up window or does not. In general, a binary endpoint can be summarized as the number of participants with an event and the number assessed in each group, followed by a contrast between groups. The choice of contrast and model affects how the result is expressed and what assumptions are made. The registry record does not report a primary endpoint analysis, its model, or a group-specific event count.

The composite includes endometritis, wound infection, and other post-cesarean infections. In general, combining outcomes can provide an overall summary across related events, but component outcomes may differ in frequency and clinical meaning. A composite estimate would not tell readers the contribution of each component unless those component results were also shown. The registry lists definitions but does not report the component counts or a component-level analysis.

What would uncertainty measures add?

In general, a confidence interval communicates uncertainty around an estimated group contrast. A narrow interval indicates greater precision than a wide interval, conditional on the analysis and assumptions; an interval including values on both sides of no difference can be compatible with several possible effects. The registry record does not report a primary endpoint estimate or confidence interval. It is therefore not possible to characterize the precision of a treatment contrast from the primary result.

In general, a p-value is interpreted relative to a stated statistical model and null hypothesis. It does not indicate the probability that the null hypothesis is true, and it does not convey effect size or clinical importance. No primary-outcome p-value is reported in the registry record. No inference should be drawn from the adverse-event counts about the primary endpoint.

What do the planning illustrations show?

The sample-size section describes planning illustrations computed from the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The intended effect to detect is stated as a fraction of the observed effect. For time-to-event tables, the stated convention is total events; for other tables, it is participants per arm. These are illustrations, not the trial’s own design calculations and not observed power. The registry does not report the trial’s sample-size justification, so the illustrations should not be interpreted as evidence about what assumptions informed recruitment.

In general, a sample-size calculation estimates the amount of information needed to detect a specified effect under specified assumptions. It does not show that an effect exists, and a calculation based on an observed effect is especially distinct from a prospective design justification. The planning displays can help readers understand how assumed effect size and statistical choices relate to a hypothetical study size, but they cannot repair the absence of a reported primary comparison.

What is not recoverable from the registry entry?

The registry lists no analysis records. The statistical test or model, covariate adjustment, treatment of repeated or multiple events, handling of missing data, analysis population, and any prespecified sensitivity analyses are not reported in the registry record. It also does not report whether there were interim analyses or how any such analyses might have been controlled. Those elements should not be inferred from the randomization or masking labels. The posted results support a description of the listed outcomes and safety entries, but not reconstruction of an unreported primary analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary composite infection outcome and secondary outcomes of maternal deaths, wound hematoma or seroma, and puerperal fever. It does not report a statistical plan specifying how these outcomes were prioritized for formal testing, whether any adjustment for multiple comparisons was planned, or whether analyses were prespecified. The number of outcome measures is listed as five, but the registry record does not explain their relationship to the listed outcomes or any multiplicity strategy.

In general, testing many outcomes can increase the chance of finding an apparently unusual result by chance if each is interpreted separately. A prespecified hierarchy, adjustment method, or emphasis on estimation can help readers interpret a family of outcomes. No such approach is reported, so the secondary outcomes should not be treated as a set of confirmed findings.

The record does not report missing primary-outcome data, loss to follow-up, exclusions, or the analysis population. It is therefore not possible to determine whether the primary analysis included all randomized participants, only participants with outcome data, or another population. The safety groups list 585 and 584 participants at risk, but those denominators do not establish completeness of primary-outcome follow-up.

In general, missing outcome information can affect both the precision and interpretation of a group comparison, especially if the likelihood of missingness differs between groups or relates to outcome status. How missing data were handled, and whether sensitivity analyses were conducted, are not reported in the registry record. The reason for termination and any implications for follow-up or analysis are also not reported.

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.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for 585 participants at risk in the triclosan-coated suture group and 584 in the uncoated suture group. It reports zero serious adverse events in each group. The deaths field is also zero for each group. In the other adverse-event category, the record lists one event in the coated group and zero in the uncoated group.

These are counts in the posted safety record, not a complete description of all possible harms. The registry does not provide the event terms for serious events; its list of top serious terms is empty. The record also does not define the other adverse-event category here, describe event severity beyond the serious/other distinction, or explain how events were collected and attributed.

In general, zero recorded events does not prove that an event is impossible or that a strategy has no safety risks. Safety interpretation depends on the population observed, follow-up, event definitions, and completeness of reporting. The registry does not provide confidence intervals or a formal safety comparison. These figures should therefore be read as the posted counts, not as proof of equivalent safety or evidence about the primary infection endpoint.

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

The registry record establishes that a randomized, parallel-group trial compared triclosan-coated with uncoated sutures during cesarean delivery. It specifies a primary endpoint covering endometritis, wound infection, or another post-cesarean infection within 30 days following delivery, and it records safety counts for the two groups. It does not report a primary endpoint comparison that shows how many participants in each group experienced the composite outcome.

As a result, the record does not support a conclusion about the direction, size, or precision of a difference in infection outcomes. The stated objective is to determine whether coated sutures reduce surgical site infection; an objective is a question to be tested, not a result. The absence of a reported primary comparison does not mean that the groups had equal outcomes, nor does it establish that one strategy was better or worse.

The posted safety counts are also limited. They describe zero serious adverse events in each group, one other adverse event in the coated group and none in the uncoated group, and zero deaths in both groups. They do not establish that no unrecorded or unreported events occurred, and they do not answer the primary effectiveness question.

In general, interpreting a clinical trial requires both an estimated effect and its uncertainty, alongside the design, outcome definitions, missing-data information, and analysis methods. The registry record lacks key details for that interpretation, including the primary group-specific outcome counts, the analysis plan, and the analysis population. The terminated status adds context but does not explain whether the planned question was answered or why the study ended.

The accompanying displays and sample-size illustrations can help readers examine the posted data and hypothetical planning assumptions. They should not be taken as a substitute for a primary result. The most defensible reading is that the registry describes the comparison the trial set out to make, while its posted information does not report the result needed to resolve that comparison.

13. Why This Trial Matters Statistically

This trial is statistically notable because its registry entry separates a clear randomized comparison from the information needed to interpret that comparison. The design identifies two suture strategies and a defined infection endpoint, yet the registry record does not report a primary outcome analysis. This distinction is important: a trial’s question and design do not alone establish an answer.

The primary outcome is a composite of several infection types. In general, composite endpoints can summarize events that share a broad clinical theme, but readers need group counts and component results to understand what drives an overall contrast. Here, the registry provides endpoint definitions but no primary comparison or component counts. That leaves both the overall contrast and the contribution of individual infection types unknown in the posted record.

The entry also illustrates why design labels are not a replacement for statistical reporting. Randomization and triple masking describe intended features, but the record does not give the analysis plan, analysis population, handling of missing data, or interim-analysis information. These omissions limit assessment of bias, precision, and the relationship between the reported data and the original question.

The sample-size section has a different purpose from a trial’s prospective design justification. Its stated calculations are planning illustrations based on the observed effect and assumptions, not observed power. Distinguishing those illustrations from the trial’s own design rationale prevents a retrospective calculation from being mistaken for evidence that the study was adequately planned or that a result is conclusive.

For biostatistical reading, the central lesson is to keep design, endpoint, analysis, and result distinct. The registry identifies a clinically focused randomized comparison, but its posted primary-outcome information is insufficient to quantify the comparison. That is a reporting limitation, not a finding of no difference.

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.

The main trial-specific limitation for interpretation is that the registry record does not report the primary outcome counts or a group comparison. Without those data, readers cannot assess the observed infection contrast or its uncertainty. The record also does not give component-level results, so the contribution of endometritis, wound infection, and other post-cesarean infections cannot be examined separately.

The trial is marked terminated, but the reason is not reported in the registry record. The listed primary completion date does not explain whether follow-up was complete or whether termination changed the planned analysis. The registry does not report the number of participants assessed for the primary endpoint, missing outcome data, or the analysis population. Enrollment and safety denominators should not be treated as a substitute for those details.

Further design and methods information is absent: eligibility criteria, randomization procedures, allocation concealment, which roles were masked, outcome ascertainment methods, statistical model, covariate adjustment, multiplicity strategy, and sensitivity analyses are not reported in the registry record. The record also does not state whether any interim analyses occurred. These omissions limit assessment of how the design was implemented and how results would have been analyzed.

The adverse-event information is narrow. The registry lists serious events, other events, and deaths, but does not give serious-event terms, a definition of the other-event category, or details of safety follow-up and attribution. The counts therefore describe only the posted categories and should not be interpreted as a full assessment of safety.

Finally, the planning illustrations are not the trial’s design justification and are not observed power. They cannot resolve uncertainties created by the missing primary analysis or missing methods information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Antibacterial-coated Sutures at Time of Cesarean — NCT03386240.
• Registry record last updated 2026-06-22; status last verified 2026-06.
• Results first posted 2026-06-22.
• 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

This Phase 4 randomized, triple-masked, parallel-group trial compared triclosan-coated with uncoated sutures used throughout cesarean delivery. The registry lists enrollment of 1169, a terminated status, and a primary endpoint of participants with endometritis, wound infection, or another post-cesarean infection within 30 days following delivery.

The registry record does not report a primary endpoint comparison, group-specific infection counts, an effect estimate, or its uncertainty. It lists zero serious adverse events and zero deaths in each group, alongside one other adverse event in the coated-suture group and none in the uncoated group. The reason for termination, analysis population, missing-data handling, and statistical analysis plan are not reported in the registry record. The sample-size displays are planning illustrations, not the trial’s original design justification or observed power.