Application of PRGF (Plasma Rich in Growth Factors) to Reduce the Healing Time After Pilonidal Sinus Excision. A Randomized 5-years Prospective Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 主要终点
- healing time(days) of pilonidal sinus wound excision
研究概览
简要总结
The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.
详细描述
prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications.
this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients among 13 and 65 years old
- •Possibility of observation during the follow-up period
- •Patients who have read and signed informed consent
排除标准
- •Abscessed pilonidal sinus
- •Recurrent pilonidal sinus
- •Patients treated with immunosuppressive drugs or anticoagulants
研究组 & 干预措施
control group
sinus pilonidal excision and standard cares
干预措施: sinus pilonidal excision and standard cares (Procedure)
PRGF group
sinus pilonidal excision+ PRGF
干预措施: sinus pilonidal excision+ PRGF (Procedure)
结局指标
主要结局
healing time(days) of pilonidal sinus wound excision
时间窗: 6 months
次要结局
- postoperative pain(1 month)
研究者
Juan Bellido Luque.MD
Ph.D
Hospital Quiron Sagrado Corazon