CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Control +2 moreother
Likely dose
microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04211597
NCT04211597N/ACompleted
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EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound

Chang Gung Memorial Hospital·interventional·Posted Dec 26, 2019·Updated Dec 26, 2019

In Brief

A clinical study evaluating Control, Silicone gel, and 1 other intervention for Cesarean Wound and Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCesarean Wound, Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2019
Enrollment StartSep 5, 2017
Primary CompletionApr 20, 2018
Study CompletionDec 28, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.5 years ago

Interventions

Controlother

No scar prevention or treatment.

Silicone gelother

Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)

microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcgother

4ml (40 mcg) of Me-EGF spray will be given by the operating physician prior to wound closure, followed by daily application of 5 mcg until day +5 after delivery. Starting from day +14, participants will receive FDA approved Silicone gel to be applied to the Cesarean wound twice a day for two months. Participants also receive routine post-partum care as usual.