跳至主要内容
临床试验/NCT06298110
NCT06298110尚未招募2 期

The Effect of PRP on Wound Healing in High Risk Patients Undergoing Abdominal Hysterectomy

Helwan University0 个研究点目标入组 80 人开始时间: 2024年3月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
尚未招募
入组人数
80
主要终点
changes in wound healing

研究概览

简要总结

To evaluate the effect of PRP on wound healing in high risk patients undergoing abdominal hysterectomy.

详细描述

Hysterectomy is one of the most common lines of surgical treatment of various uterine disorders as it provides definitive relief from the associated burdensome symptoms with an estimated prevalence of 13.1 per 10,000 women. The indications for hysterectomy include uterine leiomyomas (fibroid), dysfunctional uterine bleeding, endometrial adenomyosis, genital prolapse, massive postpartum hemorrhages and uterine cancers. Abdominal hysterectomy is still the most commonly used approach although there have been some preferences for vaginal and laparoscopic approaches.

Abdominal hysterectomy is associated with risk of complications. In high-risk women undergoing abdominal hysterectomy, wound healing can be particularly challenging due to a variety of factors, including poor tissue quality, compromised immune function, and underlying medical conditions.

Wound healing is a complex process that involves a series of events that are critical for the restoration of tissue integrity and function. Platelet-rich plasma (PRP) has emerged as a promising therapeutic option for enhancing wound healing in high risk patients. PRP is a concentrated source of platelets and growth factors derived from the patient's own blood. It has been shown to promote tissue regeneration and repair by stimulating cell proliferation, angiogenesis, and collagen synthesis. PRP has been used successfully in a variety of clinical settings, including orthopedics, dentistry, and dermatology.

PRP which contains concentrated growth factors have been reported to accelerate wound healing by30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions by supplying large amounts of growth factors and chemokines. When platelets become activated, they secrete Seven fundamental protein growth factors initiating all wound healing process, including platelet-derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) & insulin like growth factor 1(ILGF 1), which participate in the acceleration of wound healing process.

A randomized controlled trial conducted by Tehranian et al. (2016) evaluated the use of PRP in high risk women after caesarian section. The study found that patients treated with PRP had significantly faster wound healing and a significant reduction in pain compared to those who received standard care. Similarly, another study by Fanning et al. (2007) investigated the use of PRP in women undergoing gynecologic surgery, there were no apparent adverse effects, and pain was significantly reduced.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • - Female patients aged >18 years.
  • Patients undergoing abdominal hysterectomy.
  • Patients with a high risk of wound healing complications, including: obesity, diabetes mellitus, use of corticosteroid medication or smoking.

排除标准

  • - Patients with hemoglobin (Hb) < 10 g/dL.
  • Patients with platelet levels < 110 × 103/uL.
  • Patients with coagulation disorders (on anticoagulant).
  • Patients with malignancy

研究组 & 干预措施

PRP group

Experimental

on the morning of surgery, 30 mL of venous blood will be drawn from the patient in anticoagulant-containing PRP tube for preparation of PRP solution. The drawn blood will be centrifuged at 1,200 rpm for 12 minutes to be separated into three layers: an upper layer that contains platelets and white blood cells, an intermediate thin layer (the buffy coat) that is rich in white blood cells, and a bottom layer that contains red blood cells. The upper and intermediate buffy layers will be transferred to an empty sterile tube. The plasma will be centrifuged again at 3,300 rpm for 7 minutes to help with the formation of soft pellets (erythrocytes and platelets) at the bottom of the tube. Pellets are homogenized in the lower third (5 mL) of the plasma to create the PRP. The prepared PRP solution will be transferred within sterile single use syringe (3cm) from the laboratory to the operation room, then applied and spread over the subcutaneous space before skin closure

干预措施: Platelets Rich plasma of the same patient (Biological)

Control group

No Intervention

the patients received no topical treatment in the subcutaneous tissue or the skin before closure during surgery

结局指标

主要结局

changes in wound healing

时间窗: day 1, day 7, and day 30

REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis, discharge approximation of the wound edges, each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing

次要结局

  • Hospital readmission(1 month post-operatively)
  • Vancouver scar scale changes(day 1, day 7, and day 30)
  • Visual Analog Scale changes(day 1, day 7, and day 30)
  • Infection(Up to 1 month)

研究者

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

Ahmed Mohammed Ahmed Mohammed El sayed

Doctor

Helwan University

相似试验