Barbed Suture for Hysterotomy Closure During Cesarean Section: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Barbed Suture for Hysterotomy Closure During Cesarean Section (NCT04622267), a randomized na study. The primary outcome is Quantitative Blood Loss.

2. Clinical Question

The randomized parallel-group comparison focuses on the suture used to close the uterine incision. It does not compare cesarean delivery with another mode of delivery, and it does not compare different approaches to the overall operation. The posted primary outcome is a continuous measure, reported as a group mean with a standard deviation. That allows the groups to be compared in terms of average blood loss, while the spread describes participant-to-participant variability.

The study also lists closure time, use of additional hemostatic sutures, surgical site infection, and change in pain among its secondary outcomes. These outcomes address different aspects of the procedure and follow-up. They do not replace the primary question about quantitative blood loss. The specific eligible population beyond scheduled cesarean section, including any exclusions or baseline clinical characteristics, is not reported in the registry record.

3. Trial Design

The registry record describes a randomized, parallel-group trial with no masking. Participants were assigned to barbed suture or standard antimicrobial suture for hysterotomy closure. The study is listed as completed, with enrollment of 226. The phase is recorded as NA. The sponsor is Icahn School of Medicine at Mount Sinai.

The recorded study start date is 2021-07-21, and the primary completion date is 2024-01-08. The registry summary says participation will last 1 year and describes collection of primary and secondary outcome data. It also describes a telephone survey 2 weeks following the procedure to assess pain, bowel and bladder habits, and evidence of wound infection. The registry's outcome timeframe for the posted primary measure and several secondary measures is Day 1, at delivery.

The intervention is the suture used to close the uterine incision, rather than a broader change to cesarean care. The control arm is described as standard antimicrobial suture, specifically vicryl, and the barbed arm is identified as STRATAFIX Symmetric PDS Plus Knotless Tissue. The registry summary states that the barbed suture is approved by the FDA for use in soft tissue approximation and describes its use in this study as not off-label.

Details of the randomization sequence, allocation concealment, stratification, and procedures for maintaining treatment assignment are not reported in the registry record. The trial is listed as unmasked, but the record does not specify whether outcome assessors or analysts were masked. The original protocol's design assumptions, including its intended sample size and the rationale for that size, are not reported in the registry record. The posted enrollment should therefore be read as the enrolled sample, not as evidence about the assumptions used to plan recruitment.

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 Quantitative Blood Loss, measured over Day 1, At delivery.

The primary endpoint is quantitative blood loss, abbreviated QBL in the registry summary. It measures the amount of blood loss associated with delivery and is recorded in mL on Day 1, at delivery. The outcome is reported as a mean and standard deviation for each randomized group. The mean describes the group's average measured blood loss, while the standard deviation describes how much individual measurements vary around that average.

Blood loss is relevant to this comparison because the study question is whether the suture used for hysterotomy closure is associated with a difference in blood loss. Quantifying rather than relying only on a subjective impression can provide a numerical outcome for comparing the assigned closure methods. The registry record does not describe the specific measurement procedure, the instruments used, how blood loss was attributed to the hysterotomy, or whether any adjustment was made for other sources of bleeding. Those operational details are not reported in the registry record.

The endpoint is a group-level summary, not a statement that every participant experienced the group mean. A difference in means describes the contrast between average outcomes in the randomized arms. It does not, by itself, show the distribution of individual outcomes or establish the cause of every measured difference. The posted comparison should therefore be interpreted together with its interval estimate and the variability in each arm, rather than as a precise prediction for an individual patient.

7. Results Posted in the Registry

• Barbed Suture: mean 596.50 versus 641.80 on control; difference -45.30 (95% CI -121.39 to 30.79), standardized effect d = -0.16; z-test p = 0.243.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Time for Hysterotomy Closure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Barbed Suture: mean 277.90 versus 326.30 on control; difference -48.40 (95% CI -77.19 to -19.61), standardized effect d = -0.44; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Barbed Suture than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Participants Who Need Additional Hemostatic Sutures

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Barbed Suture: 59.3% (67/113) versus 44.2% (50/113) on control; risk difference 15.0 percentage points (95% CI 2.2 to 27.9), risk ratio 1.34 (1.04–1.73); unadjusted two-proportion z-test p = 0.024.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Barbed Suture than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Number of Hemostatic Sutures

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Barbed Suture: mean 0.90 versus 1.10 on control; difference -0.20 (95% CI -0.53 to 0.13), standardized effect d = -0.16; z-test p = 0.229.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Barbed Suture and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address procedural time, use of additional hemostatic sutures, infection, and pain. The posted numerical findings are mixed rather than moving in one consistent direction. Closure time is lower in the barbed arm, while more participants in that arm needed additional hemostatic sutures. The mean number of hemostatic sutures points in the other direction, with a lower mean in the barbed arm. These outcomes measure different features of the operation, so they need not show parallel patterns.

This mixed pattern does not overturn or explain the primary blood-loss comparison. Quantitative blood loss remains the designated primary outcome, and its interval is compatible with both a reduction and an increase in the barbed arm. Secondary outcomes may give context about the procedure, but they cannot be substituted for the primary endpoint or used to claim that the primary result has a different direction. The registry record does not report a prespecified hierarchy among secondary outcomes.

The study description lists surgical site infection and change in pain among the secondary outcomes, and the telephone survey description includes bowel and bladder habits and wound infection. Numerical results for infection and pain are not reported in the registry record. As a result, the available numerical pattern does not cover every outcome named in the record.

Unadjusted secondary results carry less weight as confirmatory evidence when multiple outcomes are examined and the record does not state how that multiplicity was handled. Even without adjustment, each result may be useful as descriptive evidence, but isolated p-values can overstate how persuasive a collection of findings is. The registry record does not report an adjustment method, a prespecified decision rule for secondary outcomes, or reported analyses for these outcomes. Their interpretation should therefore remain cautious and supportive rather than definitive.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time for Hysterotomy Closure
• Number of Participants Who Need Additional Hemostatic Sutures
• Number of Hemostatic Sutures
• Number of Participants With Surgical Site Infections (SSI)
• Rate of Surgical Site Infections (SSI)
• Change in Pain Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary and continuous secondary outcomes are reported as means and standard deviations. A mean condenses a set of measurements into an average. A standard deviation describes dispersion among individual measurements; it is not the uncertainty interval for the mean difference. The group standard deviations for quantitative blood loss are 300.2 mL in the standard-suture arm and 283.2 mL in the barbed-suture arm. The substantial variability relative to the group means is a reason to read the estimated contrast together with its interval, rather than focusing only on the two averages.

What does the mean difference represent?

The mean difference compares the average outcome in the barbed arm with the average in the standard arm. For quantitative blood loss, the reported direction is barbed minus standard, giving -45.3 mL. A negative value means the posted average is lower in the barbed group for an outcome where larger values indicate more measured blood loss. The estimate is an unadjusted comparison, not a model-adjusted effect. The registry record does not report adjustment for baseline variables or other covariates.

A difference in means is expressed in the outcome's original units, which makes it possible to interpret the contrast on the blood-loss scale. However, it remains an average contrast. It does not indicate that each participant in one group had less blood loss than each participant in the other group. Nor does it describe the full shape of the outcome distribution. The registry record does not provide individual participant data or distributional summaries beyond means and standard deviations.

How should the interval and p-value be read?

An interval estimate conveys a range of effect values compatible with the data and the method used to construct it. For the primary comparison, the interval runs from -121.4 to 30.79 mL. Because it includes no difference, the data do not distinguish clearly between a reduction and an increase in average blood loss using this interval. The interval does not mean that all values inside it are equally plausible, and it does not establish that the true effect must lie within the displayed bounds. The confidence level and interval-construction method are not reported in the registry record.

The unadjusted p-value for the primary comparison is 0.243. A p-value describes how unusual data at least as incompatible with a specified no-difference model would be, under the assumptions of the test. It is not the probability that the no-difference model is true, nor is it the probability that the result occurred by chance. The registry record does not report the test used or the analysis assumptions. The p-value should be read alongside the effect estimate and interval, not as a replacement for them.

Why does variability matter?

When participant outcomes vary widely, a group mean can be estimated less precisely than when outcomes are more tightly clustered, all else being equal. The standard deviations describe this observed spread, whereas the interval describes uncertainty in the group contrast. Keeping these concepts separate prevents a common mistake: treating a standard deviation as though it were an interval for the treatment comparison. The registry record gives both group spread and a comparison interval, which answer different questions.

General statistical explanation: over-dispersion occurs when the observed variability is greater than a model assumes. If a model underestimates variability, its uncertainty estimates can be too narrow and its test results can appear more decisive than warranted. The registry record does not report an over-dispersion assessment, and the posted primary measure is continuous with a mean and standard deviation. There is no basis in the record for claiming that a particular over-dispersion correction was used.

How are the count outcomes different?

The additional-hemostatic-suture outcome is a count of participants who needed additional sutures, reported as 50 of 113 in the standard arm and 67 of 113 in the barbed arm. The comparison is a risk difference of 0.150, with an interval from 0.022 to 0.279 and an unadjusted p-value of 0.024. A risk difference expresses an absolute difference in the proportion of participants with the outcome, with the direction determined by the arm order. The registry also gives relative measures, but those do not replace the absolute comparison and are not adjusted for other variables.

The number of hemostatic sutures is a separate continuous outcome, reported as a mean. It captures the average count rather than whether a participant needed any additional suture. One outcome can move differently from the other because the occurrence of any additional suture and the average count among the full group are not identical summaries. The registry's posted results should be interpreted according to the outcome definition rather than treating all suture-related measures as interchangeable.

Unadjusted comparisons do not account for possible differences in measured or unmeasured characteristics beyond randomized assignment. Randomization is intended to support comparability of groups on average, but the registry record does not report baseline characteristics or an adjusted analysis. The posted calculations should therefore be understood as simple comparisons of the reported group summaries. The record lists no reported analyses for the posted secondary outcomes.

11. Confidence Intervals and Precision

For quantitative blood loss, the estimated mean difference is -45.3 mL, with an interval from -121.4 to 30.79 mL. The point estimate favors lower average blood loss in the barbed arm, but the interval spans both lower and higher average blood loss in that arm. This range shows that the estimate is uncertain enough that the data do not settle the direction of the average difference. The registry record does not report the confidence level or construction method for the interval, so those details cannot be assessed from the record.

The group standard deviations, 300.2 mL for standard suture and 283.2 mL for barbed suture, describe substantial variation in individual blood-loss measurements. They are not confidence limits, and they should not be read as the range containing most participants. The interval for the mean difference instead communicates uncertainty about the group contrast. The interval's width is relevant to precision: it permits a range of materially different possible contrasts, rather than tightly locating the effect near the point estimate.

Precision is not the same as clinical importance. Even a precisely estimated difference would need to be considered in relation to a clinically meaningful threshold, which is not reported in the registry record. Conversely, an interval that includes no difference does not establish equivalence or rule out effects that could matter. No equivalence margin or non-inferiority margin is reported in the registry record.

The secondary intervals also vary in what they convey. The interval for closure time lies below no difference, while the interval for the mean number of hemostatic sutures spans no difference. The interval for the risk difference in participants needing additional sutures lies above no difference. These findings describe the posted unadjusted estimates; they do not correct for testing multiple outcomes. As the registry record does not report confidence levels, planned interval procedures, or multiplicity handling, the interval values should be interpreted as posted estimates with those limitations in mind.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on observed effects, not the trial's original design calculation. The continuous and binary outcome entries give participants per arm, not a combined total. There are no time-to-event planning figures in the posted results; the general planning note says time-to-event tables, when present, give total events. The original trial's sample-size assumptions and justification are not reported in the registry record.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect: the full observed effect, 75% of the observed effect, or 50% of the observed effect. These are hypothetical target effects used to illustrate recruitment needs under the stated assumptions. They do not show what the original investigators expected when designing the trial.

The 80% power column represents the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the specified effect under its assumptions, if that effect were real. The 90% power column gives the corresponding planning count for a 90% chance. These are design calculations, not probabilities that the observed finding is true. The planning table and curve are not observed power.

Smaller effects are harder to distinguish from random variation, so the planning calculations require more participants per arm when the assumed effect is reduced. That relationship is an important feature of the illustrations, not evidence that the trial was inadequately designed. The posted calculations use an observed effect from this trial, which is uncertain and may not equal the effect a future study would encounter. The registry record does not report the original target enrollment, its anticipated effect size, or its planned power. The illustrations therefore help readers understand how sample requirements change with assumptions, but cannot reconstruct the study's own planning process.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -45.300; pooled standard deviation σ = 291.824.
2. n = 2 × (1.96 + 0.842)² × 291.824² / -45.300² = 651.5, rounded up to 652 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -45.3                      # observed difference in means
sigma <- 291.823816711385                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4622267)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 652 (80% power), 873 (90% power)
 75% of observed effect: n per arm = 1,159 (80% power), 1,551 (90% power)
 50% of observed effect: n per arm = 2,606 (80% power), 3,489 (90% power)
power.t.test: 652.4 
Simulated power at n = 652 per arm: 0.790 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry record names multiple outcomes: quantitative blood loss as the primary outcome and several secondary measures covering closure time, additional hemostatic sutures, surgical site infection, and pain. When multiple outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately. Statistical methods can address this issue through prespecified testing hierarchies or adjustment procedures. The registry record does not report whether any such approach was planned or used.

The posted secondary comparisons are unadjusted. The unadjusted p-values therefore describe each comparison on its own and do not account for the number of outcomes examined. The record does not specify a trial-wide significance threshold for the outcome analyses. The 0.05 value stated in the sample-size planning assumptions belongs to those planning illustrations; it is not evidence of the threshold used for the trial's original analysis.

Missing-data handling is not reported in the registry record. The record does not state whether any participants had unavailable outcome measurements, how missing values were treated, or whether any sensitivity analyses were conducted. The posted arm summaries list the group sample sizes, but those entries alone do not establish how missingness was assessed or handled for each endpoint.

The analysis populations are also not reported in the registry record. It does not say whether the primary analysis followed intention-to-treat assignment, used a per-protocol population, or applied another rule. The registry lists no sponsor-reported analyses for the primary or secondary outcomes. The contrasts shown are unadjusted comparisons of the posted summaries, and details of the statistical test, model, covariate adjustment, and handling of protocol deviations are not reported in the registry record.

These omissions do not invalidate the observed summaries, but they limit assessment of how the analyses were chosen and whether all randomized participants contributed to each outcome. They also make it difficult to distinguish planned analyses from analyses selected after results were known. Readers should treat the posted estimates as descriptive evidence with incomplete information about analysis populations, missingness, and multiplicity.

15. 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 serious adverse-event counts are 0 among 113 participants in the standard-suture arm and 0 among 113 participants in the barbed-suture arm. Deaths are recorded as 0 in each arm. The registry record lists no top serious adverse-event terms. These entries indicate that no serious adverse events or deaths were recorded in the posted safety figures for either group.

For other adverse events, the record reports 0 among 113 participants in the standard arm and 1 among 113 participants in the barbed arm. The record does not give a term or description for that event in the safety information. It therefore cannot be characterized further from the registry record.

These counts are descriptive; they do not establish that the arms have identical safety profiles or that uncommon events are absent. The record does not report the event-collection definitions, severity categories for other events, attribution to the suture, or additional details about monitoring and follow-up. The safety figures should be read as the adverse-event counts posted for this trial, not as a comprehensive assessment of every possible risk.

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

The result does not show a clear difference in average quantitative blood loss between the randomized groups. The point estimate is lower in the barbed-suture arm, but its interval includes values indicating higher average blood loss in that arm as well. The data therefore leave meaningful uncertainty about the direction and size of the primary contrast. They do not prove that the closure methods are equivalent, and they do not establish that either method has no effect on blood loss.

The result also does not answer every question about the procedure. Secondary outcomes show a mixed pattern, and numerical results for infection and pain are not reported in the registry record. The posted results cannot establish how the suture choice affects those unreported outcomes. The registry record also does not provide a clinical threshold for judging whether a particular difference in blood loss or closure time would matter to patients or clinicians.

Random assignment makes the comparison informative about the assigned closure approaches in this trial, but the registry record does not describe all aspects of allocation, adherence, missing data, or analysis populations. Generalizability is also limited by the recorded study setting and population description: the study concerns scheduled cesarean section, while detailed eligibility criteria and participant characteristics are not reported in the registry record.

The adverse-event counts are small in number and should not be treated as proof that no safety differences exist. The record supplies limited event detail and does not explain the event-collection process. Likewise, the unadjusted secondary comparisons should not be treated as definitive evidence because the record does not report how multiple outcomes were handled.

Overall, the posted findings are best understood as estimates with uncertainty, rather than a simple verdict for or against either suture. They describe the outcomes recorded in the trial and can inform interpretation of the specific comparison, but they do not support a broad claim about all patients, all cesarean procedures, or all possible outcomes.

17. Why This Trial Matters Statistically

This trial illustrates why a randomized comparison should be interpreted through both its estimated effect and its uncertainty. The primary point estimate is directionally lower for barbed suture, but the interval spans opposite directions. Looking only at the means could make the apparent difference seem more conclusive than the comparison supports; looking only at the p-value would also miss the range of effects compatible with the posted data.

The secondary measures demonstrate that related procedural outcomes can tell different stories. Time to close the hysterotomy, whether an additional hemostatic suture was needed, and the average number of such sutures are distinct outcomes. Treating them as interchangeable would obscure their different definitions and observed patterns. The trial is also a useful example of why prespecified outcome priorities matter when several results are examined.

The registry record has further value because it makes the limits of interpretation visible. It lists the design, enrollment, outcomes, and selected adverse-event counts, but does not report the original sample-size rationale, analysis populations, missing-data methods, or multiplicity plan. Those omissions are statistically important: they affect how confidently readers can connect the reported summaries to the full set of planned analyses.

Finally, planning illustrations based on the observed effects help show how recruitment requirements depend on the size of the effect a study aims to detect. They are not a substitute for the original design calculation, which is not reported in the registry record. Distinguishing such planning exercises from the trial's observed evidence prevents a common misreading of post hoc sample-size calculations.

18. 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 gives limited detail about eligibility and participant characteristics. It identifies the study population as patients having scheduled cesarean section, but does not report a fuller description of who could enroll, who was excluded, or the baseline characteristics of the randomized groups. The degree to which the findings apply beyond the recorded study population is therefore difficult to assess.

Details of the blood-loss measurement process are not reported in the registry record. The record does not describe how QBL was measured, whether measurement was standardized, or how other sources of blood loss were handled. It also does not explain the operational definition of closure time or additional hemostatic sutures.

The analysis information is incomplete. The registry does not report the original sample-size assumptions, analysis populations, missing-data procedures, statistical test for each comparison, or adjustment for covariates. It does not report a multiplicity plan for the primary and secondary outcomes. These limitations matter when interpreting unadjusted p-values and deciding how much weight to give secondary findings.

Although several secondary outcomes are named, numerical results for surgical site infection and change in pain are not reported in the registry record. The adverse-event information is also limited, including no description of the single other adverse event listed for the barbed arm. The registry describes a telephone survey 2 weeks following the procedure, but does not report its completion or response information.

The record lists the study as unmasked and provides no further information about masking of outcome assessors or analysts. It also does not report allocation concealment, treatment adherence, or protocol deviations. These trial-specific gaps limit assessment of possible measurement and analysis biases, as well as the completeness of outcome reporting.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Barbed Suture for Hysterotomy Closure During Cesarean Section — NCT04622267.
• Registry record last updated 2024-11-05; status last verified 2024-10.
• Results first posted 2024-11-05.
• 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.

22. Record Summary

NCT04622267 is a completed randomized, unmasked, parallel-group trial sponsored by Icahn School of Medicine at Mount Sinai. It enrolled 226 participants and compared barbed suture with standard antimicrobial suture for hysterotomy closure during scheduled cesarean section. The primary endpoint was quantitative blood loss in mL at delivery.

Average blood loss was 641.8 mL with standard suture and 596.5 mL with barbed suture. The unadjusted mean difference was -45.3 mL, with an interval from -121.4 to 30.79 mL and an unadjusted p-value of 0.243. The interval includes effects in either direction, leaving uncertainty about the primary comparison.

Posted secondary results show different patterns across closure-related measures. Numerical results for some outcomes named in the registry, including infection and pain, are not reported in the registry record. The record also does not report the original sample-size rationale, analysis populations, missing-data procedures, or multiplicity handling. Adverse-event counts list no serious events or deaths in either arm and one other adverse event in the barbed arm.