Examining the Effect of Additional Injection of Freshly Collected Autologous Adipose Tissue to Bascom's Cleft Lift Surgery in the Treatment of Pilonidal Disease- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- healing
研究概览
简要总结
In brief, the right management of complex or recurrent pilonidal disease (PD) is still controversial. In our institution we treat these conditions with Bascom's cleft lift surgery. Though this approach for most parts is beneficial, a large proportion of patients will suffer from prolonged post operative healing. We have published some positive results on treating non-healing postoperative wounds after cleft lift surgery with autologous fatty cell transplantation. The overall aim of the project is to investigate whether the addition of autologous fat cell transplantation in the surgical treatment of PD reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, we will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.
详细描述
The overall aim of the project is to investigate whether the addition of autologous fatty cell transplantation in the surgical treatment of pilonidal disease (PD) reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, the investigators will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.
The investigators hypothesize that addition of autologous fatty cell injection to Bascom's cleft lift operation for pilonidal disease will reduce the proportion of patients with poor postoperative healing compared to patients in the control group who are treated with Bascom's cleft lift operation alone.
The primary endpoint of this study is healing of the pilonidal lesion (max 1 defect ≤5mm, no undermining) after 4 weeks and 12 weeks.
Further, symptom development, postoperative pain, complication rate, time to healing and recurrence rates are also explored.
BRIEF LITERATURE REVIEW:
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
Patients will all receive BCL surgery and all have two small incisions in in the lumbar region with local anesthetic injection and compression bandages. Only the intervention group with have fatty cells harvested and injected in the surgical wound. The out comes assessor is blinded to which treatment has been given.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced pilonidal disease with indication for surgery with Bascom's cleft lift surgery due to either
- •Primary extensive manifestation where minimally invasive surgery is not possible
- •Lack of healing after previous surgery (> 2 months)
- •Recurrence after previous elective surgery
- •Informed and written consent, as well as consent for follow-up.
- •Danish speaking/reading and thus able to understand Danish patient information, questionnaires and the pleje.net system.
排除标准
- •Acute infection in pilonidal disease
- •Pregnancy
- •BMI <20 and >35
- •Smokers (stop smoking at least 6 weeks before and after the operation)
- •Insulin-dependent diabetes
- •Age <15 years
- •Bilateral extension not suitable for BCL surgery
研究组 & 干预措施
BCL surgery with fatty cell injection arm
Patients will undergo BCL surgery and additionally have to small incisions made in the lumbar region from which 80 ml of fatty cells are harvested. After harvest local anesthetics are injected bilaterally and a compression bandage applied. The fatty cells are injected into the surgical wound before closure. All wounds are lateralized and close with a suction drain removed after 3 days
干预措施: injection of freshly collected adipose cells (Other)
BCL surgery with fatty cell injection arm
Patients will undergo BCL surgery and additionally have to small incisions made in the lumbar region from which 80 ml of fatty cells are harvested. After harvest local anesthetics are injected bilaterally and a compression bandage applied. The fatty cells are injected into the surgical wound before closure. All wounds are lateralized and close with a suction drain removed after 3 days
干预措施: Bascoms Cleft lift procedure (Procedure)
BCL surgery alone arm
Patients will undergo BCL surgery. Additionally two small incisions are made in the lumbar region, local anesthetics are injected bilaterally and a compression bandage applied. All wounds are lateralized and close with a suction drain removed after 3 days
干预措施: Bascoms Cleft lift procedure (Procedure)
结局指标
主要结局
healing
时间窗: 12 weeks
Healing of the pilonidal lesion (max 1 defect ≤5mm, no undermining)
healing
时间窗: 4 weeks
Healing of the pilonidal lesion (max 1 defect ≤5mm, no undermining)
次要结局
- Time to healing(upto 12 months)
- recurrence(60 months)
- Symptom development(pre-operatively, at 4 weeks, 12 weeks and 12 months)
- postoperative pain(first 14 postoperative days)
- complications(12 weeks)
- recurrence(12 months)
- recurrence(36 months)
研究者
Susanne Haas
MD PhD, assosciate professor
Randers Regional Hospital