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Safety and efficacy of a cream on the wound healing and scar of cesarean section

Safety and efficacy of Lecoxen cream on the wound healing and scar of cesarean section: a prospective observational clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN51125312
Enrollment
74
Registered
2024-05-10
Start date
2023-06-07
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment of wound derived after cesarean section Pregnancy and Childbirth

Interventions

All pregnant women submitted to a Pfannenstiel skin incision will be included in the study. After surgery, skin will be closured by agrafes (Agrafes Appose, Medtronic Italy, Milano, Italy) and will be

Sponsors

Department of Obstetrics and Gynecology “Veris delli Ponti Hospital”
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Healthy women aged 18 - 45 years scheduled for CS

Exclusion criteria

Exclusion criteria: 1. Smoking 2. At risk for premature birth 3. Obesity 4. Hypertension 5. Diabetes and infections 6. Use systemic and topical corticosteroids 7. Presence of previous surgical scarring near the incision site 8. Autoimmune diseases 9. Skin problems 10. Known hypersensitivity to at least one of the components of the formulation Lecoxen cream or Vaseline

Design outcomes

Primary

MeasureTime frame
1. The quality of scar was examined using the VSS scale at baseline and after 28 days 2. The wound healing was evaluated using REEDA scale at baseline and after 14 days

Secondary

MeasureTime frame
Adverse events measured using patient records up to the end of the study

Countries

Italy

Contacts

Public ContactAndrea Tinelli
Ginecologia.poscorrano@asl.lecce.it+39 3392074078

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026