Safety and efficacy of a cream on the wound healing and scar of cesarean section
| ISRCTN | ISRCTN51125312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51125312 |
| Secondary identifying numbers | 75839/2023 |
- Submission date
- 08/05/2024
- Registration date
- 10/05/2024
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
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 is to evaluate the safety and effectiveness of a silicone-based medical device (Lecoxen cream, Ekuberg Pharma, Italy) in healing wounds and scars derived from cesarean sections in nulliparous women. Methods:
Who can participate?
Women, ranging in age from 18 to 45 years, who underwent CS
What does the study involve?
Participants are divided in two groups of treatment (Lecoxen cream or Vaseline). The quality of scar will be examined using the Vancouver scar scale after 28 days, while wound healing will be evaluated using the redness, edema, ecchymosis, discharge, and approximation (REEDA) scale on the 14th day following CS.
What are the possible benefits and risks of participating?
Possible benefits: reduciton of healing time of wound and amelioration of scar tissue
Possible risk: allergies to any of the ingredients contained in the proposed treatment
Where is the study run from?
Department of Obstetrics and Gynecology “Veris delli Ponti Hospital” (Italy)
When is the study starting and how long is it expected to run for?
June 2023 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Andrea Tinelli, andreatinelli@gmail.com
Contact information
Scientific
Via castrignano
Martano
73025
Italy
 ORCID ID |
0000-0003-2360-3456 |
|---|---|
| Phone | +39 3294513080 |
| davide.carati@ekubergpharma.com |
Public, Principal Investigator
Direttore U.O.C. Ginecologia e Ostetricia, Ospedale Veris delli Ponti
Scorrano
73020
Italy
| ORCID ID |
0000-0001-8426-8490 |
|---|---|
| Phone | +39 3392074078 |
| Ginecologia.poscorrano@asl.lecce.it |
Study information
| Study design | Single center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Safety and efficacy of Lecoxen cream on the wound healing and scar of cesarean section: a prospective observational clinical trial |
| Study hypothesis | Lecoxen cream is more effective than pure Vaseline in reducing time of healing of wound resulting from cesarean section and improve quality of resulting scar. |
| Ethics approval(s) |
Approved 06/06/2023, Ethical committee of Lecce (Via Miglietta 5, Lecce, 73100, Italy; +39 836 420273; cometico@asl.lecce.it), ref: 75839/2023 |
| Condition | Treatment of wound derived after cesarean section |
| Intervention | 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 divided into two 71 groups: 37 mothers were allocated to the treatment group with Lecoxen cream, 37 to the placebo group treated with 72 Vaseline (Vaseline F.U., Marco Viti, Italy). Participants were assigned in a 1:1 ratio with sequential assignment, depending on time and date of enrolment. After the stitches’ removal, normally on the seventh post-operative day, patients will be instructed to apply respective treatments from the first day to the twenty-eighth day, once a day. Patients will be asked not to use any other medicament for wound healing. A board-certified gynecologist, all doctors working in the department where the study will be performed, will supervised the screening, the enrollment of study participants from a panel of candidates, and will follow the patients during the study. The state of wound healing will be evaluated at baseline and after 14 days (T1) of the treatment using Redness, Edema, Ecchymosis, Discharge, and Approximation (REEDA) scale. The degree of quality of the resulting scar will be finally evaluated after 28 days (T2), using Vancouver Scar Scale (VSS). |
| Intervention type | Device |
| Pharmaceutical study type(s) | Dose response |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lecoxen cream |
| Primary outcome measure | 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 outcome measures | Adverse events measured using patient records up to the end of the study |
| Overall study start date | 01/06/2023 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 74 |
| Total final enrolment | 74 |
| Participant inclusion criteria | Healthy women aged 18 - 45 years scheduled for CS |
| Participant 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 |
| Recruitment start date | 07/06/2023 |
| Recruitment end date | 01/12/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Scorrano
73020
Italy
Sponsor information
Hospital/treatment centre
Via Giuseppina Delli Ponti
Scorrano
73020
Italy
| Phone | +39 836420564 |
|---|---|
| ginecologia.poscorrano@asl.lecce.it |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned pubblication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Andrea Tinelli andreatinelli@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/07/2024 | 27/01/2025 | Yes | No |
Editorial Notes
27/01/2025: Publication reference added.
08/05/2024: Trial's existence confirmed by Ethical committee of Lecce
