Single-blinded, Randomized Study Comparing Healing After Bascom's Cleft Lift Operation for Pilonidal Disease With or Without Prevena ™ and ACTIV.A.C ™ Therapy System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Primary healing
研究概览
简要总结
In a single-blinded randomized, controlled study design the investigators wish to examine to effect of Prevena + ActiV.A.C. therapy system on the postoperative healing in patients operated for chronic pilonidal disease using Bascoms' Cleft Lift procedure. At the department of surgery at The regional Hospital i Randers Denmark the investigators handle cases from the entire region and have a decent patient volume. The investigators have used Bascoms' Cleft left since 2013 and registered complications and experience wound deshisseance or prolonged healing in approx. 15% causing the investigators to challange the postoperative regime.
详细描述
Background Pilonidal disease (PS) is a common disorder that occurs in the crena ani. A paradigm shift of our perception of the pathology of this disorder has been on its way for several decades and the treatment is slowly starting to follow.
The estimated incidence is 26 per 100,000 although this is subject to large geographical variation. Men present themselves with symptomatic pilonidal disease more than twice as often as women and in population surveys of young students, a 10: 1 male / female ratio has been found, including also asymptomatic pilonidal cysts. The disorder usually affects the younger population with average age at first manifestation of 21 years for men and 19 for women.
Acute manifestations are infected and result in pilonidal abscesses. The treatment of acute abscesses within pilonidal disease is uncontroversial and is based on lateral incision and drainage with subsequent open healing.
The treatment of chronic pilonidal disease, on the other hand, is still controversial. Traditional surgical approach is based on excision of the affected tissue with primary closure or open secondary healing. This treatment, regardless of the manifestation of disease, is characterized by poor healing, complicated postoperative ulceration and recurrence.
Since April 2010, there has been a combination and standardization of the treatment of complicated pilonidal disease at the regional hospital in Randers (Denmark), where patients with 1) recurrence after previous surgery, 2) missing healing > 2 months after surgery and 3) extensive / fistulatory pilonidal disease are offered Bascom's cleft lift (BCL ) operation for the condition.
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 (Outcomes Assessor)
盲法说明
Patients will be seen and the primary outcome assesed by a nurse in the out patient department who is blinded to the postoperative care the patient has recieved.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrence after previous surgery for pilonidal disease, cases of poor postoperative healing (> two months) or primary extensive/fistulating disease referred to Randers Regional Hospital for assessment for reconstructive BCL surgery.
排除标准
- •Patients under 18 years of age
- •Patients who smoke (not offered this type of surgery), ceased min. 6 weeks pre-operatively
- •Patients with PS lesions are ≤ 3 cm from the anus
- •Patients with allergies to Silver or acrylic
- •Patients who cannot adhere to study protocol
研究组 & 干预措施
Prevena
Patients randomized to application of Prevena ™ and ACTIV.A.C ™ Therapy System 4-7 days post-operatively. Patients will return to the surgical day clinic to have the system removed either at day 7 or when/ if function ceases. Patients receive 3 days oral antibiotics postoperatively (Ciproxin 250 mg x 2 and Metronidazole 500 mg x 3). Sutures are removed at clinical control after 14 days and patients are seen again by BCL surgeon after 3 months and are discharged when completely healeddrainage and conventional wound dressing
干预措施: Prevena™ og ACTIV.A.C™ Therapy System. (Device)
Conentional postoperative care
patients randomized to convetional postoperative regime with a penrose drain (passive) and a dry draping for 24 hours and after usage of sanitary pads. Patients receive 3 days oral antibiotics postoperatively (Ciproxin 250 mg x 2 and Metronidazole 500 mg x 3). Drain is removed after 24 hours and Sutures are removed at clinical control after 14 days and patients are seen again by BCL surgeon after 3 months and are discharged when completely healeddrainage and conventional wound dressing.
结局指标
主要结局
Primary healing
时间窗: 14 days after surgery
Evaluation of BCL cicatrices after 14 days of healing by the following two criteria\*: 1) existence of defects in the cicatricees (defects ≤ 5 mm considered fully healed) and 2) undermining of the cicatrices.
次要结局
- Health perception(upto 12 months after surgery)
- Long term healing(3 months after surgery)
- early recurrence(up to 12 months after surgery)
- post operative pain(14 days after surgey)