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

NCT04211597 | Completed DMC

• 1 other identifier: 201601310A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• Vascularity

  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

  Evaluation of Vascularity is done at: month 3+ follow-up visit.

• Pigmentation

  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

  Evaluation of Pigmentation is done at: month 3+ follow-up visit.

• Pliability

  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

  Evaluation of Pliability is done at: month 3+ follow-up visit.

• Height

  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

  Evaluation of Height is done at: month 3+ follow-up visit.

• Vascularity

  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

  Evaluation of Vascularity is done at: month 6+ follow-up visit.

• Pigmentation

  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

  Evaluation of Pigmentation is done at: month 6+ follow-up visit.

• Pliability

  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

  Evaluation of Pliability is done at: month 6+ follow-up visit.

• Height

  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

  Evaluation of Height is done at: month 6+ follow-up visit.

• Vascularity

  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

  Evaluation of Vascularity is done at: month 9+ follow-up visit.

• Pigmentation

  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

  Evaluation of Pigmentation is done at: month 9+ follow-up visit.

• Pliability

  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

  Evaluation of Pliability is done at: month 9+ follow-up visit.

• Height

  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

  Evaluation of Height is done at: month 9+ follow-up visit.

Study Arms (3)

Group 1: Control

SHAM COMPARATOR

Participants receive no scar prevention and treatment for Cesarean wounds.

Other: Control

Group 2: Silicone gel

ACTIVE COMPARATOR

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.

Other: Silicone gel

Group 3: Silicone gel plus Me-EGF

EXPERIMENTAL

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.

Other: Silicone gel; Other: microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg

Interventions

Control OTHER

No scar prevention or treatment.

Group 1: Control

Silicone gel OTHER

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

Group 2: Silicone gel; Group 3: Silicone gel plus Me-EGF

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

Group 3: Silicone gel plus Me-EGF

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Keelung Chang Gung Memorial Hospital

Keelung, Taipei, 204, Taiwan

Location

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MeSH Terms

Conditions

Cicatrix; Pregnancy Complications

Interventions

Silicone Gels

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 26, 2019
• Study Start: September 5, 2017
• Primary Completion: April 20, 2018
• Study Completion: December 28, 2018
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)