EGF-loaded Chitosan to Facilitate Epithelial Healing And Prevent Scar Formation of Cesarean Wound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Height
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Height
时间窗: Evaluation of Height is done at: month 9+ follow-up visit.
Height of the scar is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: flat; 1: 0-2mm; 2: 2-5mm; 3: \> 5mm
Vascularity
时间窗: Evaluation of Vascularity is done at: month 9+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Pink; 2: Red; 3: Purple
Pliability
时间窗: Evaluation of Pliability is done at: month 9+ follow-up visit.
Pliability is one the the four subscales in Vancouver Scar Scale (VSS). Score range: 0-5. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Supple; 2: Yielding; 3: Firm; 4: Banding; 5: Contracture
Pigmentation
时间窗: Evaluation of Pigmentation is done at: month 9+ follow-up visit.
Vascularity is one of the four subscales in Vancouver Scar Scale (VSS). Score range: 0-3. It is a Likert-type scale of which score 0 indicates normal or none, and a higher score indicates the severity of the specific condition. Assessed at 3 time points: Month 3+, Month 6+ and Month 9+ postpartum visits. A trained nurse practitioner evaluates participant's Cesarean wound scar and assigns a score when the participant returns to the follow-up appointment. 0: Normal; 1: Hypo-pigmentation; 2: Mixed-pigmentation; 3: Hyper-pigmentation
次要结局
未报告次要终点
研究者
TING-CHANG CHANG
Clinical Professor
Chang Gung Memorial Hospital