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Platelet Rich Plasma and Wound Healing After Cesarean Section

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ClinicalTrials.gov Identifier: NCT04669353
Recruitment Status : Completed
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Nabih Elkhouly, Menoufia University

Brief Summary:

Objective: To assess the effect of autologous Platelet Rich Plasma (PRP) on wound healing and pain perception in high risk women undergoing cesarean sections in a low resource setting.

Methods: This was a randomized controlled trial of 200 women who attended the outpatient clinic of Menoufia University Hospital for elective cesarean surgery. The women were randomly assigned to two groups. The intervention group received PRP after surgery, whereas the control group received the usual care. Outcomes included Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) scale, Vancouver scar scale (VSS), and the visual analog scale (VAS).


Condition or disease Intervention/treatment Phase
Infection Drug: Platelet rich plasma Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The invesigators randomized participants in a 1:1 ratio to two equal groups containing one hundred patients each (intervention and control groups). A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the patients after signing the informed consent. The study authors were unaware of the envelope allocation sequence. Participants and outcome assessors did not know which group had been assigned to for the duration of the study.
Primary Purpose: Treatment
Official Title: The Effect of Autologous Application of Platelet Rich Plasma on Wound Healing and Pain Perception After Cesarean Section in a Low Resource Setting
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Platelet Rich Plasma
In the operating room before the start of each procedure, approximately 15 cm of whole blood was drawn from the uninvolved arm of each patient in the intervention group (group I) into a 20 ml sterile syringe containing citrate for anticoagulation. The blood was immediately centrifuged at 3200 Revolutions per Minute (PRM). Following 15 minutes of centrifugation, 4 - 5 mL of PRP was obtained. Then, the PRP was buffered by using sodium bicarbonate. After closure of the fascia and prior to skin closure, PRP was directly applied to the subcutaneous tissue of the wound site by using a sterile syringe.
Drug: Platelet rich plasma
approximately 15 cm of whole blood was drawn from the uninvolved arm of each patient in the intervention group (group I) into a 20 ml sterile syringe containing citrate for anticoagulation. The blood was immediately centrifuged at 3200 Revolutions per Minute (PRM). Following 15 minutes of centrifugation, 4 - 5 mL of PRP was obtained. Then, the PRP was buffered by using sodium bicarbonate.

No Intervention: control group
In the control group (group II), the patients did not receive topical treatment and the subcutaneous tissue was cleaned with normal saline before skin closure



Primary Outcome Measures :
  1. Redness, Edema, Ecchymosis, Discharge, Approximation scale changes [ Time Frame: day 1, day 7 and 6 months ]
    for assessing the changes in wound healing. REEDA as a descriptive scale has 4 points in a categorical score that measures 5 items of healing: redness (hyperemia), edema, ecchymosis, discharge, and approximation of the wound edges (coaptation). Each item is rated on a scale of 0 to 3, and total scores may range from 0 to 15. A lower score indicates better healing


Secondary Outcome Measures :
  1. Vancouver scar scale changes. [ Time Frame: day 1, day7, and 6 months ]
    Vancouver scar scale (VSS) use to detect changes of formation of keloids or hypertrophic scars. It assesses 4 subjective variables: vascularity, height/thickness, pliability, and pigmentation within a possible range of 0 - 14 for the total score. A lower score indicates better healing.

  2. Visual Analog Scale changes [ Time Frame: day 1, day7, and 6 months ]
    Pain was evaluated by the visual analog scale system (VAS) which assesses changes of pain via a continuous measurement instrument.The score is determined by measuring the distance (mm) between the no pain anchor to the point that the patient marks, providing a range of scores from 0 - 10. A higher score indicates greater pain intensity



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index (BMI) > 30 kglcm2
  • prior cesarean section
  • pregestational or gestational diabetes
  • hypertensive disorders of pregnancy
  • placenta Previa
  • twin pregnancy
  • anemia
  • corticosteroid medication

Exclusion Criteria

  • • chronic pain disorders

    • hepatitis
    • thrombocytopenia
    • coagulation disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04669353


Locations
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Egypt
Menoufia university hospital
Cairo, Egypt
Sponsors and Collaborators
Menoufia University
Investigators
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Principal Investigator: Nabih Elkhouly Faculty of medicine, Menoufia University, Egypt
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Responsible Party: Nabih Elkhouly, associate professor, Menoufia University
ClinicalTrials.gov Identifier: NCT04669353    
Other Study ID Numbers: 198190PSGN33
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nabih Elkhouly, Menoufia University:
Platelet Rich Plasma
wound Healing
Pain
Cesarean Section