PRP Gel in Wound Closure in Recurrent CS

Overview

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.

Full Title of Study: “Platelet Rich Plasma Gel in Wound Closure in Recurrent Cesarean Section:Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2017

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.

Interventions

  • Biological: platelet rich plasma gel
    • Platelet rich plasma is prepared from fresh whole blood which is collected from a peripheral vein stored in acid citrare dextrose solution A (ACD-A)anticoagulant and processed to increase platelets by separating various components of blood
  • Biological: saline
    • 64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure

Arms, Groups and Cohorts

  • Experimental: 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
  • Placebo Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
    • Time Frame: one month
    • Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 25 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: rasha medhat abdul-hady, Dr. – Ain Shams University
  • Overall Official(s)
    • RASHA DR MEDHAT, MD, Principal Investigator, Ain Shams University
    • Rasha M Abdul-hady, MD, Principal Investigator, Ain Shams University

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