PRP Gel in Wound Closure in Recurrent CS

NCT02775747 | Completed Phase 1 DMC

• 1 other identifier: PRP-CS
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Previous Incision; Scar; Previous Cesarean Section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  one month

Study Arms (2)

platelet rich plasma gel

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

platelet rich plasma gel 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

Also known as: PRP, platelete rich plasma (PRP)

platelet rich plasma gel

saline 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

Saline

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Rasha

Cairo, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• RASHA DR MEDHAT, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Rasha M Abdul-hady, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: May 18, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2016-04

Locations

EG (1)