Back to results: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section
Primary Purpose
Caesarean Wound, Hypertrophic Surgical Scar, Keloid Scar Following Surgery
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Protescal gel
Sponsored by
About this trial
This is an interventional prevention trial for Caesarean Wound focused on measuring caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing
Eligibility Criteria
Inclusion Criteria:
- All women undergoing elective caesarean section, without any history of previous abdominal surgery ; who planned for further pregnancy and consented to participate in this study.
Exclusion Criteria:
- Patient that allergic to protescal
- Patient with previous abdominal surgery
- Patient refusal or patients who are not able to give consent
Sites / Locations
- Universiti Kebangsaan Malaysia Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Protescal group
Control group
Arm Description
Caesarean-section was done in the usual manner. The transverse suprapubic skin incision was made and abdominal layers opened as usual. After delivering the baby, uterine muscle is closed in two layers with braided absorbable suture, polyglactin 910 (Vicryl no 1). After hemostasis secure, 1 mL Protescal gel was applied at the uterine suture site in Protescal group. Peritoneal layer closed using braided absorbable suture, polyglactin 910 (Vicryl no 1). Rectus sheath was sutured using braided absorbable suture, polyglactin 910 (Vicryl no 1). Subcutaneous tissue closed interruptedly using braided absorbable suture, polyglactin 910 (Vicryl no 1). Protescal gel (0.5 mL) was applied over the subcutaneous tissue prior to skin closure in Protescal group. The skin was then closed with the subcuticular method using braided absorbable suture, polyglactin 910 (Vicryl 3-0).
Caesarean-section was done in the usual manner. The transverse suprapubic skin incision was made and abdominal layers opened as usual. After delivering the baby, uterine muscle is closed in two layers with braided absorbable suture, polyglactin 910 (Vicryl no 1). After hemostasis secure, No Protescal gel was applied at the uterine suture site in this Control group. Peritoneal layer closed using braided absorbable suture, polyglactin 910 (Vicryl no 1). Rectus sheath was sutured using braided absorbable suture, polyglactin 910 (Vicryl no 1). Subcutaneous tissue closed interruptedly using braided absorbable suture, polyglactin 910 (Vicryl no 1). No application of Protescal gel (0.5 mL) over the subcutaneous tissue prior to skin closure in this Control group. The skin was then closed with the subcuticular method using braided absorbable suture, polyglactin 910 (Vicryl 3-0).
Outcomes
Primary Outcome Measures
Name of the Measurement:Assessment of degree of caesarean wound healing. Measurement Tool:REEDA scale Unit of measure:"Percentage (%) of patients with..."
Wound healing assessed on 10th-day post caesarean section using REEDA scale of which the criteria assessed include redness, edema, ecchymosis, discharge and approximation. The REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation) scale assesses the inflammation process and tissue healing. The minimum score is 0 and the maximum score is 15; whereby the higher the score denotes the more severe the tissue trauma and healing outcome.Percentage of patients in both groups with REEDA Scale scores of 0, 1-2 and ≥ 3 is determined.
Name of the Measurement : Assessment of Caesarean wound keloid formation & degree of scarring Measurement Tool : Modified Vancouver scar scale (MVSS) Unit of measure:"Percentage (%) of patients with..."
Third-month post-caesarean section, the degree of scarring was assessed using the Modified Vancouver scar scale (MVSS) which assessed pigmentation, height, pliability and vascularity of the scar. This scale focused on six parameters including scar height and thickness, pliability, vascularity, pigmentation, symptoms of itch and pain to generate a score ranging from 0 to 18 points.For the purpose of this study, a hypertrophic scar (HTS) was defined as one which was raised by at least 2 mm and had a total MVSS of 5 points or more (4). Thus a higher score would means a more hypertrophic scar formation. If a patient had more than one MVSS recorded during their follow up, the highest value was used.
Name of the Measurement : Assessment of Caesarean wound keloid formation & degree of scarring Measurement Tool : Colour photograph of wound Unit of measure : "Percentage (%) of patients with..."
Third-month post-caesarean section, the degree of scarring was assessed by colour photography if deemed necessary for comparison purposes. This would also depend on patient's agreement to her scar being photographed. If agreeable and deemed necessary, thus a patient's assessment was supplemented with colour photographs for later review and comparison.
Secondary Outcome Measures
Name of the Measurement: Assessment of pelvic adhesions noted during next caesarean section.Measurement Tool: Intra-operative visual assesment of pelvic adhesions noted during next caesarean section.Unit of measure:"Percentage (%) of patients with..."
To assess the degree of pelvic adhesion formation intra-operatively during the next caesarean section. Visual assesment (by surgeons) of intra-operative findings of pelvic adhesions noted during next caesarean section which is documented in the intra-operative notes.
Full Information
NCT ID
NCT04951869
First Posted
May 30, 2021
Last Updated
June 27, 2021
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT04951869
Brief Title
: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section
Official Title
Assessing the Effectiveness of Protescal In Preventing Post Caesarean Section Hypertrophic Scar and Keloid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 26, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to evaluate the effectiveness of Protescal in preventing post caesarean section hypertrophic scar and keloid formation.
Detailed Description
A randomized controlled trial was conducted for six months involving 90 women who underwent caesarean section without any history of previous abdominal surgery and who were planning for further pregnancy. They were randomized into two groups. The Protescal group was given Protescal gel which was applied over the uterine incision site and subcutaneous tissue layer prior to skin closure (n = 45), whereas in the control group, no Protescal gel was applied (n = 45). The primary outcome was to assess the healing of the external scar.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Wound, Hypertrophic Surgical Scar, Keloid Scar Following Surgery
Keywords
caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
concurrent 2 arms with study arm and control arm of women undergoing caesarean section without any previous abdominal surgeries
Masking
Participant
Masking Description
control group receives no protescal application while study group does
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protescal group
Arm Type
Experimental
Arm Description
Caesarean-section was done in the usual manner. The transverse suprapubic skin incision was made and abdominal layers opened as usual. After delivering the baby, uterine muscle is closed in two layers with braided absorbable suture, polyglactin 910 (Vicryl no 1). After hemostasis secure, 1 mL Protescal gel was applied at the uterine suture site in Protescal group. Peritoneal layer closed using braided absorbable suture, polyglactin 910 (Vicryl no 1). Rectus sheath was sutured using braided absorbable suture, polyglactin 910 (Vicryl no 1). Subcutaneous tissue closed interruptedly using braided absorbable suture, polyglactin 910 (Vicryl no 1). Protescal gel (0.5 mL) was applied over the subcutaneous tissue prior to skin closure in Protescal group. The skin was then closed with the subcuticular method using braided absorbable suture, polyglactin 910 (Vicryl 3-0).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Caesarean-section was done in the usual manner. The transverse suprapubic skin incision was made and abdominal layers opened as usual. After delivering the baby, uterine muscle is closed in two layers with braided absorbable suture, polyglactin 910 (Vicryl no 1). After hemostasis secure, No Protescal gel was applied at the uterine suture site in this Control group. Peritoneal layer closed using braided absorbable suture, polyglactin 910 (Vicryl no 1). Rectus sheath was sutured using braided absorbable suture, polyglactin 910 (Vicryl no 1). Subcutaneous tissue closed interruptedly using braided absorbable suture, polyglactin 910 (Vicryl no 1). No application of Protescal gel (0.5 mL) over the subcutaneous tissue prior to skin closure in this Control group. The skin was then closed with the subcuticular method using braided absorbable suture, polyglactin 910 (Vicryl 3-0).
Intervention Type
Drug
Intervention Name(s)
Protescal gel
Intervention Description
Protescal gel (0.5 mL) was again applied over the subcutaneous tissue prior to skin closure in Protescal group
Primary Outcome Measure Information:
Title
Name of the Measurement:Assessment of degree of caesarean wound healing. Measurement Tool:REEDA scale Unit of measure:"Percentage (%) of patients with..."
Description
Wound healing assessed on 10th-day post caesarean section using REEDA scale of which the criteria assessed include redness, edema, ecchymosis, discharge and approximation. The REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation) scale assesses the inflammation process and tissue healing. The minimum score is 0 and the maximum score is 15; whereby the higher the score denotes the more severe the tissue trauma and healing outcome.Percentage of patients in both groups with REEDA Scale scores of 0, 1-2 and ≥ 3 is determined.
Time Frame
Day 10th post caesarean section
Title
Name of the Measurement : Assessment of Caesarean wound keloid formation & degree of scarring Measurement Tool : Modified Vancouver scar scale (MVSS) Unit of measure:"Percentage (%) of patients with..."
Description
Third-month post-caesarean section, the degree of scarring was assessed using the Modified Vancouver scar scale (MVSS) which assessed pigmentation, height, pliability and vascularity of the scar. This scale focused on six parameters including scar height and thickness, pliability, vascularity, pigmentation, symptoms of itch and pain to generate a score ranging from 0 to 18 points.For the purpose of this study, a hypertrophic scar (HTS) was defined as one which was raised by at least 2 mm and had a total MVSS of 5 points or more (4). Thus a higher score would means a more hypertrophic scar formation. If a patient had more than one MVSS recorded during their follow up, the highest value was used.
Time Frame
3 months post caesarean section
Title
Name of the Measurement : Assessment of Caesarean wound keloid formation & degree of scarring Measurement Tool : Colour photograph of wound Unit of measure : "Percentage (%) of patients with..."
Description
Third-month post-caesarean section, the degree of scarring was assessed by colour photography if deemed necessary for comparison purposes. This would also depend on patient's agreement to her scar being photographed. If agreeable and deemed necessary, thus a patient's assessment was supplemented with colour photographs for later review and comparison.
Time Frame
3 months post caesarean section
Secondary Outcome Measure Information:
Title
Name of the Measurement: Assessment of pelvic adhesions noted during next caesarean section.Measurement Tool: Intra-operative visual assesment of pelvic adhesions noted during next caesarean section.Unit of measure:"Percentage (%) of patients with..."
Description
To assess the degree of pelvic adhesion formation intra-operatively during the next caesarean section. Visual assesment (by surgeons) of intra-operative findings of pelvic adhesions noted during next caesarean section which is documented in the intra-operative notes.
Time Frame
3 years post caesarean section
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All women undergoing elective caesarean section, without any history of previous abdominal surgery ; who planned for further pregnancy and consented to participate in this study.
Exclusion Criteria:
Patient that allergic to protescal
Patient with previous abdominal surgery
Patient refusal or patients who are not able to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anizah Ali, MD(UKM),MOG(UKM)
Organizational Affiliation
UKMMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
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: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section
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