EGF-loaded Chitosan to Facilitate Healing and Prevent Scar Formation of Cesarean Wound
NCT ID: NCT04211597
Last Updated: 2019-12-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-05
Study Completion Date
2018-12-28
Brief Summary
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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
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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.
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.
Conditions
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Cesarean Wound
Scar; Previous Cesarean Section, Complicating Pregnancy or Childbirth, Affecting Fetus or Newborn
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Given the distinctive nature between types of scar treatments (spray vs gel, or no treatment at all), care provider and patients will not be blind to the group assignment. However, outcomes assessors are trained nurse practitioners and research associates, who do not have access to participants' group assignment records.
Study Groups
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Group 1: Control
Participants receive no scar prevention and treatment for Cesarean wounds.
Group Type
SHAM_COMPARATOR
Control
Intervention Type
OTHER
No scar prevention or treatment.
Group 2: Silicone gel
Each participant in Group 2 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.
Group Type
ACTIVE_COMPARATOR
Silicone gel
Intervention Type
OTHER
Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)
Group 3: Silicone gel plus Me-EGF
1. 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.
2. Each participant in Group 3 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.
Group Type
EXPERIMENTAL
Silicone gel
Intervention Type
OTHER
Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)
microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg
Intervention Type
OTHER
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.
Interventions
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Control
No scar prevention or treatment.
Intervention Type
OTHER
Silicone gel
Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)
Intervention Type
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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Sponsor Role
lead
Responsible Party
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TING-CHANG CHANG
Clinical Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Keelung Chang Gung Memorial Hospital
Keelung, Taipei, Taiwan
Site Status
Countries
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Taiwan
References
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Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
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Kirsner RS, Eaglstein WH. The wound healing process. Dermatol Clin. 1993 Oct;11(4):629-40.
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BACKGROUND
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Shin JU, Kang SW, Jeong JJ, Nam KH, Chung WY, Lee JH. Effect of recombinant human epidermal growth factor on cutaneous scar quality in thyroidectomy patients. J Dermatolog Treat. 2015 Apr;26(2):159-64. doi: 10.3109/09546634.2014.906034. Epub 2014 Apr 8.
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BACKGROUND
Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg. 2005 Sep 15;116(4):1013-20; discussion 1021-2. doi: 10.1097/01.prs.0000178397.05852.ce.
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BACKGROUND
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BACKGROUND
Signorini M, Clementoni MT. Clinical evaluation of a new self-drying silicone gel in the treatment of scars: a preliminary report. Aesthetic Plast Surg. 2007 Mar-Apr;31(2):183-7. doi: 10.1007/s00266-005-0122-0.
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RESULT
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RESULT
McCarty M. An evaluation of evidence regarding application of silicone gel sheeting for the management of hypertrophic scars and keloids. J Clin Aesthet Dermatol. 2010 Nov;3(11):39-43. No abstract available.
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RESULT
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RESULT
Borgognoni L. Biological effects of silicone gel sheeting. Wound Repair Regen. 2002 Mar-Apr;10(2):118-21. doi: 10.1046/j.1524-475x.2002.00205.x. No abstract available.
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RESULT
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RESULT
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RESULT
Idriss N, Maibach HI. Scar assessment scales: a dermatologic overview. Skin Res Technol. 2009 Feb;15(1):1-5. doi: 10.1111/j.1600-0846.2008.00327.x.
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RESULT
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RESULT
Kelly AP. Medical and surgical therapies for keloids. Dermatol Ther. 2004;17(2):212-8. doi: 10.1111/j.1396-0296.2004.04022.x.
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RESULT
Anzarut A, Olson J, Singh P, Rowe BH, Tredget EE. The effectiveness of pressure garment therapy for the prevention of abnormal scarring after burn injury: a meta-analysis. J Plast Reconstr Aesthet Surg. 2009 Jan;62(1):77-84. doi: 10.1016/j.bjps.2007.10.052. Epub 2008 Jan 14.
Reference Type
RESULT
Xue M, Jackson CJ. Extracellular Matrix Reorganization During Wound Healing and Its Impact on Abnormal Scarring. Adv Wound Care (New Rochelle). 2015 Mar 1;4(3):119-136. doi: 10.1089/wound.2013.0485.
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RESULT
Bond JS, Duncan JAL, Sattar A, Boanas A, Mason T, O'Kane S, Ferguson MWJ. Maturation of the human scar: an observational study. Plast Reconstr Surg. 2008 May;121(5):1650-1658. doi: 10.1097/PRS.0b013e31816a9f6f.
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RESULT
Chang CW, Ries WR. Nonoperative techniques for scar management and revision. Facial Plast Surg. 2001 Nov;17(4):283-8. doi: 10.1055/s-2001-18826.
Reference Type
RESULT
Berlanga-Acosta J, Gavilondo-Cowley J, Lopez-Saura P, Gonzalez-Lopez T, Castro-Santana MD, Lopez-Mola E, Guillen-Nieto G, Herrera-Martinez L. Epidermal growth factor in clinical practice - a review of its biological actions, clinical indications and safety implications. Int Wound J. 2009 Oct;6(5):331-46. doi: 10.1111/j.1742-481X.2009.00622.x.
Reference Type
RESULT
Other Identifiers
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201601310A3
Identifier Type: -
Identifier Source: org_study_id