Clinical trial NCT04951869: : 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Caesarean Wound
Hypertrophic Surgical Scar
Keloid Scar Following Surgery
Keywords: caesarean section, hypertrophic scar, keloid, anti-adhesive gel, wound healing
Lead sponsor: Universiti Kebangsaan Malaysia Medical Centre
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: concurrent 2 arms with study arm and control arm of women undergoing caesarean section without any previous abdominal surgeries
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Name of the Measurement:Assessment of degree of caesarean wound healing. Measurement Tool:REEDA scale Unit of measure:"Percentage (%) of patients with..."
timeFrame: Day 10th post caesarean section
measure: 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..."
timeFrame: 3 months post caesarean section
measure: 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..."
timeFrame: 3 months post caesarean section
Secondary outcomes:
measure: 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..."
timeFrame: 3 years post caesarean section
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Universiti Kebangsaan Malaysia Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: UKMMC
name: Anizah Ali, MD(UKM),MOG(UKM)
role: PRINCIPAL_INVESTIGATOR
References: