: Protescal: Prevention of Hypertrophic Scar and Keloid Formation Post Caesarean Section

Keloid Scar Following Surgery Clinical Trial

Official title:

Assessing the Effectiveness of Protescal In Preventing Post Caesarean Section Hypertrophic Scar and Keloid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951869
• Other study ID #: Research Code: FF-2017-170
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 26, 2017
• Est. completion date: November 16, 2017

Study information

• Verified date: June 2021
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to evaluate the effectiveness of Protescal in preventing post caesarean section hypertrophic scar and keloid formation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 16, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophic Surgical Scar
• Hypertrophy
• Keloid
• Keloid Scar Following Surgery

Intervention

Drug:
• Protescal gel
Protescal gel (0.5 mL) was again applied over the subcutaneous tissue prior to skin closure in Protescal group

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Cheras	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 10th post caesarean section
Primary	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.	3 months post caesarean section
Primary	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.	3 months post caesarean section
Secondary	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.	3 years post caesarean section