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临床试验/NCT06867328
NCT06867328已完成不适用

Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds

Gulab Devi Hospital1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
1
主要终点
Wound Healing

研究概览

简要总结

Chronic diabetic wounds are a major health concern, often taking a long time to heal and increasing the risk of complications like infections and amputations. This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) Dressing versus Normal Saline Dressing in the treatment of chronic diabetic wounds. PRP is a treatment derived from the patient's own blood that contains growth factors, which may accelerate wound healing.

Participants with chronic diabetic wounds will be randomly assigned to receive either PRP dressing or normal saline dressing. The study will measure the rate of wound healing and the time taken to achieve complete healing in both groups. It is hypothesized that PRP dressing will lead to faster and more effective wound healing compared to normal saline dressing.

Findings from this research could help improve wound care strategies for diabetic patients and provide evidence for a more effective treatment approach in clinical practice.

详细描述

After obtaining approval from the institutional review board and obtaining informed consent from study participants, all patients fulfilling the inclusion criteria were included in the study from the surgery indoor department of Gulab Devi Hospital, Lahore. Baseline characteristics, including age (in years), gender (male/female), and history of comorbidities (hypertension/ischemic heart disease/smoking), were assessed by reviewing previous medical records and taking a detailed history. The duration of diabetes (in years), duration of the wound (weeks), size of the wound (measured using a millimeter scale along the longest axis), and class of chronic diabetic wound (III/IV) were documented.

After wound debridement, patients were randomized into two equal groups by block randomization as follows:

Group A: Patients were managed with normal saline dressing. Group B: Patients were managed with PRP dressing. In this technique, the wound was washed with normal saline, and platelet-rich plasma (prepared from the patient's own blood by the hematology department) was injected into the surrounding wound area twice weekly, followed by the placement of a gauze over it.

Dressing was continued for a period of 6 weeks or until wound healing was achieved, whichever was shorter. To assess healing, all patients in both groups were followed up weekly until 6 weeks (study endpoint). The duration required to achieve wound healing was also documented. Additionally, 6 weeks post-therapy, wound size was reassessed. In cases of non-healing, alternative therapy was provided based on the wound condition and the consultant surgeon's advice. All data were recorded in a predesigned proforma and kept confidential.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-60 years.
  • •Either male or female.
  • •Chronic diabetic wound.
  • •Wagner class III and IV.

排除标准

  • •Wound sustained < 6 weeks from time of presentation.
  • •Previous history of PRP dressing use, assessed by reviewing previous medical records.
  • •History of hypersensitivity to PRP, assessed by reviewing previous medical records.
  • •Burn injury, assessed by reviewing previous medical records.
  • •Class I, II and V.

研究组 & 干预措施

Group PRP Dressing

Experimental

Patients in this group will receive platelet-rich plasma (PRP) dressing, which involves the application of autologous PRP to the chronic diabetic wound site. PRP will be prepared from the patient's own blood and applied twice weekly after wound debridement.

干预措施: Platelet-Rich Plasma (PRP) Dressing (Procedure)

Group Normal Saline Dressing

Active Comparator

Patients in this group will receive normal saline dressing, which consists of cleansing the wound with normal saline followed by application of sterile gauze. This will be performed twice weekly after wound debridement.

干预措施: Normal Saline Dressing (Procedure)

结局指标

主要结局

Wound Healing

时间窗: Evaluated weekly for up to 6 weeks

Wound healing will be assessed based on the formation of pinkish granulation tissue completely covering the wound. The healing status will be determined by a consultant surgeon through visual inspection.

次要结局

  • Duration to Achieve Wound Healing(Measured at the end of 6 weeks or at the point of complete wound healing, whichever occurs first.)

研究者

发起方
Gulab Devi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adeel Ahmed

Principal Investigator

Gulab Devi Hospital

研究点 (1)

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