PRP Gel in Wound Closure in Recurrent CS (PRP-CS)

May 12, 2017 updated by: rasha medhat abdul-hady, Ain Shams University

Platelet Rich Plasma Gel in Wound Closure in Recurrent Cesarean Section:Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt, 002
        • Rasha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
Other Names:
  • PRP
  • platelete rich plasma (PRP)
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: RASHA DR MEDHAT, MD, Ain Shams University
  • Principal Investigator: Rasha M Abdul-hady, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 7, 2016

First Submitted That Met QC Criteria

May 14, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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