Cesarean Wound Clinical Trial
Official title:
EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound
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.
Objective:
Cesarean section (CS) is a major surgical intervention that affects women at childbearing
age. Scarring from CS is expected but certainly not desirable, 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.
Materials:
The investigational dressing in this study: the microencapsulated polysaccharide and
oligopeptide-1 is provided by Good-Care Biotech, Ltd. (brand NewEpi®: 10 mcg Me-EGF/ml,
Taipei, Taiwan). The investigational dressing NewEpi® was formulated in spray solution with a
proprietary drug delivery system in which rhEGF was encapsulated in chitosan as
nanoparticles.
Silicone-based scar therapy has shown the beneficial effects of improving the appearance of
scars. Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan) is a Taiwan-FDA approved
topical silicone gel and commercially available. It is transparent, odorless and quick
drying. Concerning the applicability over lower abdomen area, silicone gel (Dermatix®) was
selected to be part of the routine care in this study.
Study Procedures:
Healthy women scheduled for cesarean delivery were 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: vascularity, pigmentation, elasticity, and height) was used for scar assessment
at the 6th month and 9th month after CS.
Eligibility was determined at the screening visit. Details of the study regarding
eligibility, purpose, study procedure, scope of care and potential risks were explained. Upon
enrollment, full medical history of the participants was obtained, including history of
hypertrophic scar or keloid. Scars from previous injuries or surgical incisions were
evaluated and recorded. Each patient was randomized to one of the three treatment arms: Group
1 (receiving no scar treatment), Group 2 (silicone gel only), and Group 3 (silicone gel plus
Me-EGF). Enrolled participants underwent Cesarean delivery performed by one of the four
obstetricians at the Department of Obstetrics and Gynecology of CGMH, as part of their
prenatal care. Other than routine surgical wound care, participants in Group 1 did not
receive any treatment pertaining to scar prevention.
The day of Cesarean delivery was recorded as Day 0. For participants in Group 3, on day 0
prior to final dermal closure, 4ml of Me-EGF (containing 40mcg microencapsulated
polysaccharide and rhEGF) was sprayed evenly along the incision site, subsequently covered
with antibiotic ointment and sterile gauze. Another 0.5 ml (5 mcg of Me-EGF) was sprayed
during dressing change on day 1 and day 5 respectively. At each dressing change, the sutured
wound was cleaned by sterile normal saline, followed by Me-EGF sprays, and waited for two
minutes to allow for absorption, then covered with dry sterile gauze. Each participant in
Group 2 and Group3 brought home two tubes of silicone gel when they returned for their
follow-up visits on day 14. They were instructed to start applying silicone gel evenly to the
wound twice a day for two months.
Study Participants:
This study is approved by the Institutional Review Board at Chang-Gung Memorial Hospital
(CGMH, Linkou, Taiwan). All practitioners and research staffs are in compliance with Good
Clinical Practice guidelines. A total of 60 females scheduled for cesarean birth will be
recruited by their primary obstetricians at the Department of Obstetrics and Gynecology of
CGMH. Prior to their enrollment, the study procedures will be explained to obtain written
informed consents. The inclusion criteria are: (1) Age of 18 or older; (2) planned for
cesarean delivery with Pfannenstiel-incision, which is one common method of performing
Caesarian sections today; (3) had not received any treatment for scars at least one month
before enrollment; and (4) capable of understanding study protocol in order to sign the
informed consent voluntarily.
Patients will be excluded if: (1) currently taking any medication that might affect outcome
evaluation of this study, including but not limited to: systemic corticosteroids or
immunosuppressants; (2) currently undergoing any treatments involving lower abdomen, or
planning to have such treatments; (3) having active infection involving abdomen at the time
of recruitment; (4) concomitant severe or poorly-controlled illness (e.g., cardiovascular,
renal, hepatic, pulmonary or gastrointestinal disease, malignancy or history of HIV
infection); (5) with any abdominal tumor; (6) undergoing urgent cesarean delivery without
proper pre-op standard procedure, or (7) having known allergy to any of the ingredients in
any of the products used in this study.
Clinical Evaluation and Outcome Measures:
There were a total of four time points at which data were collected and photos taken using
the same digital camera with fixed settings: day 0 (completion of suture on Cesarean
incision), day 1, day 5 before discharge from the hospital, and at follow-up visits in month
3, month 6, and month 9. After enrollment and before day 0, baseline photos of old Cesarean
scars were taken from participants who had prior Cesarean childbirth, in addition to photos
of other scars from those who had reported history of hypertrophic scar or keloid. Scars were
assessed using Vancouver Scar Scale. The VSS consists of 4 parameters: vascularity (0-3),
pigmentation (0-3), elasticity (0-5), and height (0-3). Prior to the study commencement, all
personnel involved had received mandatory training on scar assessment and VSS scoring. At
month 3, 6, and 9, a nurse practitioner took photos and evaluated the incision scar on each
patient with VSS. Photos of each healing wound were taken with a ruler placed adjacent to the
scar to measure the height raised above skin level. Subsequently all scores were validated
twice by different research staffs by using the photos on record. No significant
discrepancies were found. At each follow-up visit, the primary obstetrician also assessed
each patient for any side effect or adverse event.
Statistical Analysis:
Clinical data and all scar measurements were recorded on case report forms and entered in
Microsoft Excel database, later validated by different research staffs as the final scores.
Data were analyzed using jamovi statistical software (Version 0.9). Means and standard
deviations were presented for interval variables of baseline characteristics. Categorical
data at baseline were presented in frequency and analyzed with Chi-Square tests.
Nonparametric Kruskal-Wallis tests were performed on VSS scores for between group
comparisons. A p-value < 0.05 was considered statistically significant.
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