PRP Gel in Wound Closure in Recurrent CS

Phase 1

Completed

• Conditions: Previous Incision; Scar; Previous Cesarean Section
• Interventions: Biological: platelet rich plasma gel; Biological: saline

• Registration Number: NCT02775747
• Lead Sponsor: Ain Shams University

Brief Summary

There is limited application of the use of PRP in obstetrics, therefore there is a need for assessment if it is efficacy in improving skin wound healing in cesarean section.

Detailed Description

This study aims to assess the efficacy of injection of platelet rich plasma into the wound of recurrent cesarean section for improving wound healing and enhancing the shape of the wound in women undergoing cesarean section.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-05-07
• Study First Submitted QC: 2016-05-14
• Study First Posted: 2016-05-18
• Primary Completion: 2017-03
• Study Completion: 2017-04
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• elective cesarean section
• Body mass index 18:25
• Hemoglobin more than 10.5 g/d
• Albumin within normal more than or equal 3.5 g/d

Exclusion Criteria

• medical disorders(Diabetes mellitus,heart disease,hypertension,systemic lupus erythematosus)
• high risk pregnancy as (placenta previa,placenta accreta)
• patient on corticosteroids medication
• primigravida subjected cesarean section
• complicated cesarean section (increased operation time,blood transfusion, drain, scrubbing of multiple surgeons)
• cesarean section due to chorioaminionitis
• postoperative complication such as:postpartum hemorrhage, paralytic ileus, sever distention..) will be dropped out from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet rich plasma gel	platelet rich plasma gel	Injection of Platelet rich plasma (PRP) gel in 64 cases at time of wound closure in women undergoing cesarean section for improving wound healing after fullfit to all the inclusion and exclusion craiteria
Saline	saline	64 Controlled Women with recurrent cesarean section and fullfit to all the inclusion and exclusion craiteria will reseve saline injection at time of wound closure

Primary Outcome Measures

Name	Time	Method
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale	one month	Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (VAS) for wound healing

Secondary Outcome Measures

Name	Time	Method
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale	one month	Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale

Trial Locations

Locations (1)

Rasha; 🇪🇬 Cairo, Al Qahirah, Egypt