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Completed

NCT Number: NCT02775747

PRP Gel in Wound Closure in Recurrent CS

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.

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Key information

Conditions

Previous Incision Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Scar; Previous Cesarean Section

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Rasha

Cairo, Cairo Governorate, 002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: PRP, platelete rich plasma (PRP)

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: PRP-CS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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