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

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

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

Study Overview

• Status: Completed
• Conditions: Keloid Scar Following Surgery; Caesarean Wound; Hypertrophic Surgical Scar
• Intervention / Treatment: Drug: Protescal gel

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur
    • Cheras, Kuala Lumpur, Malaysia, 56000
      • Universiti Kebangsaan Malaysia Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protescal group; 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; Protescal gel (0.5 mL) was again applied over the subcutaneous tissue prior to skin closure in Protescal group
No Intervention: Control group; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universiti Kebangsaan Malaysia Medical Centre
• Investigators: Principal Investigator: Anizah Ali, MD(UKM),MOG(UKM), UKMMC

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): November 16, 2017

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Pathological Conditions, Anatomical; Fibrosis; Collagen Diseases; Hypertrophy; Cicatrix; Keloid; Cicatrix, Hypertrophic
• Other Study ID Numbers: Research Code: FF-2017-170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No