Safety and Efficacy of Lecoxen Cream on the Wound Healing and Scar of Cesarean Section: A Prospective Observational Clinical Trial
Bibliographic record
Abstract
Background: One of the most popular surgical procedures is the cesarean section (CS), and one of the most prevalent side effects of this procedure is wound and scar issues. The aim of this prospective, short-term, placebo-controlled study was to evaluate the safety and effectiveness of a silicone-based medical device (Lecoxen cream, Ekuberg Pharma, Carpignano Salentino, Italy) in healing wounds and scars derived from cesarean sections in nulliparous women. Methods: Seventy-four nulliparous women, ranging in age from 18 to 45, and underwent CSs, were divided in two groups of treatment (Lecoxen cream or Vaseline). The quality of scar was examined using the Vancouver scar scale after 28 days, while wound healing was evaluated using the Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scale on the 14th day following CS. Results: The treatment with Lecoxen cream determined a statistically significant improvement (p < 0.001) of the wound healing state, in terms of redness, edema, ecchymoses and discharge. Even about Vancouver Scar Scale (VSS) score there was a significative improvement in the observed group in terms of vascularization, pigmentation, flexibility and height (p < 0.001). No adverse effects were reported from the use of Lecoxen cream in participants. Conclusions: Lecoxen cream proved to be a safe and efficient treatment for wounds from CSs, making it a valuable topical to accelerate the healing process and reduce the visibility of scars. Clinical Trial Registration: The study was registered with the ISRCTN registry (https://www.isrctn.com/), registration number: ISRCTN51125312.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".