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

NCT04951869 | Completed Phase 2

• 1 other identifier: Research Code: FF-2017-170
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caesarean Wound; Hypertrophic Surgical Scar; Keloid Scar Following Surgery

Keywords

caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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..."

  3 years post caesarean section

Study Arms (2)

Protescal group

EXPERIMENTAL

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).

Drug: Protescal gel

Control group

NO INTERVENTION

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).

Interventions

Protescal gel DRUG

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

Protescal group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient that allergic to protescal
• Patient with previous abdominal surgery
• Patient refusal or patients who are not able to give consent

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anizah Ali, MD(UKM),MOG(UKM)

  UKMMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: control group receives no protescal application while study group does
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: concurrent 2 arms with study arm and control arm of women undergoing caesarean section without any previous abdominal surgeries

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: July 7, 2021
• Study Start: April 26, 2017
• Primary Completion: October 31, 2017
• Study Completion: November 16, 2017
• Last Updated: July 7, 2021

Record last verified: 2021-06

Locations

MY (1)