PRP Gel in Wound Closure in Recurrent CS

Scar; Previous Cesarean Section Clinical Trial

— PRP-CS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775747
• Other study ID #: PRP-CS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 7, 2016
• Last updated: May 12, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Previous Incision
• Scar; Previous Cesarean Section

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Rasha	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one month
Secondary	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	one month