Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial
The authors report that 42 included patients did not receive the correct suture type. This is a high level of protocol noncompliance at 20%. Given this single-intervention study design, and significant protocol violation, I question the author's use of intention-to-treat (ITT) analysis. Although ITT reporting is required by CONSORT guidelines, in some situations it is inappropriate. The purpose of ITT is to prevent incorrect conclusions resulting from treatment noncompliance or missing outcome data. In cases in which patients do not even receive the allocated intervention, its use is less clear cut; although there is no clear guidance on reporting in these situations, it may be more appropriate to exclude data or use ancillary approaches to ITT.2 Aside from expert opinion, simple logic should prevail in this study. The authors' own findings are that there was no statistically significant difference in outcome by suture type in the as-treated analysis. The prioritization of ITT results over the as-treated results therefore implies that the intention to place a given suture has an effect more significant than the actual placement of that suture. The authors' conclusion regarding the effect of suture type is not actually supported by their own data.