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临床试验/NCT04669353
NCT04669353已完成4 期

The Effect of Autologous Application of Platelet Rich Plasma on Wound Healing and Pain Perception After Cesarean Section in a Low Resource Setting

Menoufia University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Redness, Edema, Ecchymosis, Discharge, Approximation scale changes

研究概览

简要总结

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).

详细描述

The investigators conducted this randomized controlled trial from April 2018 to July 2020 at the Department of Obstetrics and Gynecology at Menoufia University Hospital, which is a large tertiary center in the Delta region in Egypt with a delivery rate of about 10000 per year. This study was approved by Menoufia university hospital ethical committee Institutional review board (198190PSGN33). The investigators obtained informed consent from all participants before initiating any study procedures. CONSORT guidelines were observed and completed.

The patients included in the study were between 20 and 40 years of age. Eligible women had one or more of the following risk factors: Body mass index (BMI) > 30 kglcm2, prior cesarean section, pregestational or gestational diabetes, hypertensive disorders of pregnancy, placenta Previa, twin pregnancy, anemia, and corticosteroid medication. Exclusion criteria were chronic pain disorders, hepatitis, thrombocytopenia, and coagulation disorders.

The investigators 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.

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. 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. For all patients, the skin was closed with polyprolene 2-0 suture with a curved cutting needle. The patients were examined by the physicians who were blinded to the group allocation on day 1, and then day 7 and 6 months after the procedure.

Pain was evaluated by the visual analog scale system (VAS) which assesses changes of pain via a continuous measurement instrument that is operationally comprised of a horizontal line, anchored at each end by verbal descriptors such as no pain and the worst pain imaginable. The subject is asked to indicate a spot on the scale that best represents her degree of pain. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Body mass index (BMI) > 30 kglcm2
  • prior cesarean section
  • pregestational or gestational diabetes
  • hypertensive disorders of pregnancy
  • placenta Previa
  • twin pregnancy
  • corticosteroid medication
  • Exclusion Criteria
  • • chronic pain disorders
  • hepatitis
  • thrombocytopenia
  • coagulation disorders

排除标准

  • 未提供

研究组 & 干预措施

Platelet Rich Plasma

Active Comparator

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.

干预措施: Platelet rich plasma (Drug)

结局指标

主要结局

Redness, Edema, Ecchymosis, Discharge, Approximation scale changes

时间窗: 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

次要结局

  • Vancouver scar scale changes.(day 1, day7, and 6 months)
  • Visual Analog Scale changes(day 1, day7, and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nabih Elkhouly

associate professor

Menoufia University

研究点 (1)

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