Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211597
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2019-12-20
Brief Title:
EGF-loaded Chitosan to Facilitate Healing and Prevent Scar Formation of Cesarean Wound
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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-EGFml 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 05 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 eg 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 09 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 005 was considered statistically significant
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-EGFml 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 05 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 eg 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 09 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 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None