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

NCT ID: NCT04951869

Last Updated: 2021-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2017-11-16

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.

Conditions

Caesarean Wound; Hypertrophic Surgical Scar; Keloid Scar Following Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Protescal gel

Intervention Type: DRUG

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

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Protescal gel

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Kebangsaan Malaysia Medical Centre

OTHER

Sponsor Role: lead

Responsible Party

Anizah Ali

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anizah Ali, MD(UKM),MOG(UKM)

Role: PRINCIPAL_INVESTIGATOR

UKMMC

Locations

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Research Code: FF-2017-170

Identifier Type: -

Identifier Source: org_study_id