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Completed

NCT Number: NCT04951869

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protescal gel

Drug

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

Primary outcomes

  1. Name of the Measurement:Assessment of degree of caesarean wound healing. Measurement Tool:REEDA scale Unit of measure:"Percentage (%) of patients with..."

    Time frame: Day 10th post caesarean section

    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.

  2. 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..."

    Time frame: 3 months post caesarean section

    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. 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..."

    Time frame: 3 months post caesarean section

    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 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..."

    Time frame: 3 years post caesarean section

    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.

Sponsors and collaborators

Lead sponsor

Universiti Kebangsaan Malaysia Medical Centre

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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