Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 8
- 主要终点
- Percentage of wounds healed
研究概览
简要总结
Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).
The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.
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
- None
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
- •Man or woman over 18 years old
- •Informed consent signed by the participant
- •Affiliation to social security system
- •Having a pilonidal sinus:
- •Asymptomatic or discovered by the patient during a routine examination
- •With chronic recurrent infection and skin rupture
排除标准
- •Patients with concomitant pathology:
- •cancer treated by chemotherapy
- •Hypertension uncontrolled systolic blood pressure>180 mmHg or diastolic> 110 mmHg
- •Severe comorbidity with reduced life expectancy less than 12 months
- •Acute cardiovascular disease (myocardial infarction, stroke, recent heart surgery) within 3 months before inclusion
- •Patients participating in another clinical trial
- •Known for intolerance to one of the dressings
- •Known pregnancy
- •Uncontrolled diabetes (fasting glucose >2g/l)
结局指标
主要结局
Percentage of wounds healed
时间窗: 75 days after surgery
次要结局
- VAS pain(every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first)
- Total surface area measure of non-healed wounds(75 days after surgery)
- antibiotics use(every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first)
- analgesic use(every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first)
- number of dressings used(every 2 weeks, from randomization up to 4 months or date of healing, whichever comes first)