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Zero SSIs in Both Groups as Prematurely Stopped Hysterectomy Prep Trial Yields No Comparative Data
No surgical site infections were recorded in either the scrub-and-paint or paint-only vaginal preparation group across 370 patients undergoing total laparoscopic hysterectomy (SSI rate 0% in both arms). The absence of any SSI events, attributable in part to premature trial discontinuation, means the study cannot draw conclusions about the relative efficacy of the two preparation methods, though vaginal spotting was observed exclusively in the scrub-and-paint group (7%, 13 patients).
What Was Studied
The trial investigated whether vaginal scrub-and-paint preparation with chlorhexidine gluconate reduces the incidence of surgical site infections compared with paint-only preparation in patients undergoing total laparoscopic hysterectomy. SSI incidence within 30 days of surgery was the primary outcome, addressing a recognized gap in consensus regarding optimal vaginal antiseptic technique for this procedure.
How It Was Studied
This was an assessor-blinded randomised controlled trial conducted at a single tertiary care hospital in Thailand. A total of 370 patients scheduled for total laparoscopic hysterectomy were enrolled, excluding individuals with immunocompromised status, intraoperative injury to adjacent organs, or contraindication to chlorhexidine gluconate. Participants were randomly assigned to receive either vaginal scrub-and-paint preparation or paint-only preparation, both using chlorhexidine gluconate. Postoperative data — including SSI occurrence, risk factors, and other outcomes — were collected prospectively over a 30-day follow-up period.
What Was Observed
- No SSIs occurred in either group. The SSI rate was 0% in both the scrub-and-paint and paint-only arms across the full 30-day observation window. This outcome precluded any statistical comparison of the primary endpoint between the two interventions.
- Vaginal spotting was reported only in the scrub-and-paint group. Thirteen patients (7%) in the scrub-and-paint arm experienced postoperative vaginal spotting, while no corresponding figure was reported for the paint-only group, suggesting this was an adverse effect associated specifically with the more intensive preparation technique.
- The study population reflected typical laparoscopic hysterectomy demographics. Median patient age was 46.5 years (IQR 43.0–51.0), median operative time was 160 minutes (IQR 125.0–198.75), and median blood loss was 50 mL (IQR 21.25–100.0), with a median hospital stay of 2 days (IQR 2.0–2.0). A minority of patients — 29 (7.8%) — had malignancy.
Why This Matters
No consensus currently exists on the optimal vaginal preparation technique for preventing surgical site infections in laparoscopic hysterectomy, making this a clinically meaningful question. The finding that scrub-and-paint preparation was associated with a higher rate of postoperative vaginal spotting — without any corresponding reduction in SSIs — raises questions about whether the additional mechanical step of scrubbing confers benefit or introduces unnecessary tissue irritation. While the trial cannot resolve the central question of comparative SSI prevention, it does indicate that the two approaches appeared broadly comparable in this cohort.
How to Read This Result
This was a prematurely discontinued trial with zero SSI events in either arm, which fundamentally limits any conclusion about whether scrub-and-paint preparation offers superior, inferior, or equivalent SSI prevention compared with paint-only preparation; the result should be interpreted as inconclusive rather than reassuring evidence of equivalence.
Limitations
The most consequential limitation is premature trial discontinuation, which resulted in zero SSI events being recorded across both groups. Without any outcome events, no meaningful statistical comparison of the primary endpoint was possible, and the study cannot determine whether one preparation method is more effective than the other at preventing SSIs. The absence of events also means the sample size, although 370 patients, was insufficient relative to what would be needed to draw reliable conclusions in a low-incidence outcome setting.