A Comparative Study on the Efficacy of Advanced PRF (A-PRF) versus Standard PRF (S-PRF) in treating Chronic Wounds, An Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in mean size reduction of wound area from the baseline wound size.
研究概览
简要总结
Advanced Platelet rich fibrin (A-PRF) represents a refinement of traditional PRF preparation techniques, aiming to enhance the concentration and bioactivity of growth factors within the fibrin matrix. This modification is hypothesised to improve the therapeutic potential of A-PRF in wound healing compared to Standard PRF (S-PRF). While both A-PRF and S-PRF have shown promise in wound healing, there remains a paucity of comparative studies evaluating their efficacy specifically in the context of chronic wound. This is an Open-Label Randomised Controlled Trial (RCT) comparing the efficacy of A-PRF versus S-PRF in treating chronic wounds. This research is warranted to provide evidence-based guidance for clinical practice and holds significant implications for advancing the field of wound care by elucidating the potential benefits of A-PRF over S-PRF in chronic wound management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with chronic wound for more than six weeks and have failed to heal by conventional treatments.
- •Wound size of less than 20cm
- •Both male and female participants.
- •Age 20 years or older.
- •Have a normal platelet count in range of 1,50,000- 4,50,000 cells/mm
- •Have a normal PT time: 11- 16 seconds.
- •Ability to provide informed consent or have a legally authorized representative able to provide consent on behalf of the participant.
- •Adequate understanding of the study requirements and ability to communicate with study personnel.
排除标准
- •Presence of an active infection at the ulcer site.
- •Patients on anticoagulants (warfarin, heparin).
- •Pregnant and lactating women.
- •Patients suffering from leukaemia, septicaemia, impaired platelet function or other haematological disorders.
- •Patients with hypoproteinaemia.
- •Patients taking long term steroid containing drugs or using steroid ointments on wounds.
结局指标
主要结局
Change in mean size reduction of wound area from the baseline wound size.
时间窗: Evaluation of wound size at week 2 and week 4 from baseline.
次要结局
- Participants Quality of Life using Wound QoL-17 Questionnaire.(Evaluation of Participants Quality of Life at week 2 and week 4 from baseline.)
研究者
Dr Ranganath V S
Surgiderma Hospital