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

Primary Purpose

Previous Incision, Scar; Previous Cesarean Section

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
platelet rich plasma gel
saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Previous Incision

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rasha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

platelet rich plasma gel

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (VAS) for wound healing

Secondary Outcome Measures

Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale

Full Information

First Posted
May 7, 2016
Last Updated
May 12, 2017
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02775747
Brief Title
PRP Gel in Wound Closure in Recurrent CS
Acronym
PRP-CS
Official Title
Platelet Rich Plasma Gel in Wound Closure in Recurrent Cesarean Section:Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previous Incision, Scar; Previous Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
platelet rich plasma gel
Arm Type
Experimental
Arm Description
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
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma gel
Other Intervention Name(s)
PRP, platelete rich plasma (PRP)
Intervention Description
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
Intervention Name(s)
saline
Intervention Description
64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure
Primary Outcome Measure Information:
Title
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale
Description
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (VAS) for wound healing
Time Frame
one month
Secondary Outcome Measure Information:
Title
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Description
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Time Frame
one month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RASHA DR MEDHAT, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rasha M Abdul-hady, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rasha
City
Cairo
State/Province
Al Qahirah
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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PRP Gel in Wound Closure in Recurrent CS

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