PRP Gel in Wound Closure in Recurrent CS

NCT ID: NCT02775747

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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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

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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.

Conditions

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Previous Incision Scar; Previous Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

platelet rich plasma gel

Intervention Type BIOLOGICAL

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

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type BIOLOGICAL

64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP platelete rich plasma (PRP)

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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rasha medhat abdul-hady

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RASHA DR MEDHAT, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Rasha M Abdul-hady, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Rasha

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PRP-CS

Identifier Type: -

Identifier Source: org_study_id

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