CompletedNot Applicable

EGF-loaded Chitosan to Facilitate Healing and Prevent Scar Formation of Cesarean Wound

Taiwan60 participantsStarted 2017-09-05

Plain-language summary

Cesarean section (CS) is a major surgical intervention that affects women at childbearing age. Scarring from CS potentially causes discomfort and psychological distress. Emerging evidence indicates that epidermal growth factor (EGF) plays crucial roles in wound healing with the potential of minimizing scar formation. This study aims to investigate the effect of microencapsulated recombinant human EGF (Me-EGF) in scar prevention. Silicone gel was incorporated as part of the routine scar treatment. Healthy women scheduled for cesarean delivery will be enrolled and randomized to three groups: (1) no scar treatment, (2) silicone gel only, or (3) silicone gel plus Me-EGF. Vancouver Scar Scale (VSS) will be used for scar assessment at the 6th month and 9th month after CS.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age of 18 or older * Planned for cesarean delivery with Pfannenstiel-incision * Had not received any treatment for scars at least one month before enrollment * Capable of understanding study protocol in order to sign the informed consent voluntarily Exclusion Criteria: * Currently taking any medication that might affect outcome evaluation of this study, including but not limited to: systemic corticosteroids or immunosuppressants * Currently undergoing any treatments involving lower abdomen, or planning to have such treatments * Having active infection involving abdomen at the time of recruitment * Concomitant severe or poorly-controlled illness (e.g., cardiovascular, renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV infection) * With any abdominal tumor * Undergoing urgent cesarean delivery without proper pre-op standard procedure * Having known allergy to any of the ingredients in any of the products used in this study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vascularity

Timeframe: Evaluation of Vascularity is done at: month 3+ follow-up visit.

Pigmentation

Timeframe: Evaluation of Pigmentation is done at: month 3+ follow-up visit.

Pliability

Timeframe: Evaluation of Pliability is done at: month 3+ follow-up visit.

Height

Timeframe: Evaluation of Height is done at: month 3+ follow-up visit.

Vascularity

Timeframe: Evaluation of Vascularity is done at: month 6+ follow-up visit.

Pigmentation

Timeframe: Evaluation of Pigmentation is done at: month 6+ follow-up visit.

Pliability

Timeframe: Evaluation of Pliability is done at: month 6+ follow-up visit.

Trial details

NCT IDNCT04211597

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04-20

View on ClinicalTrials.gov More Cesarean Wound trials