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

NCT04211597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-12-26

No results posted yet for this study

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.

Conditions

  • Cesarean Wound
  • Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn

Interventions

OTHER

Control

No scar prevention or treatment.

OTHER

Silicone gel

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

OTHER

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

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2018-04-20
Completion
2018-12-28

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211597 on ClinicalTrials.gov