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临床试验/NCT03757572
NCT03757572终止不适用

Secondary Intention Wound Healing, in Patients Subjected to Surgical Resection of Pilonidal Cyst, Using Alginate Dressings With Silver and High-G Cellulose, Compared to the Use of Simple Gauze Dressings: Examination of the Quality of Life

Larissa University Hospital2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年12月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
65
试验地点
2
主要终点
Wound healing time

研究概览

简要总结

The purpose of this study is to compare the application of alginate dressings with silver and high-G cellulose and the use of simple gauge dressings in patients submitted to surgical resection of pilonidal cyst. The present trial will focus on the postoperative quality of life during the secondary intention wound healing.

详细描述

Pilonidal cyst was first described by Hodges in 1880. The disease of pilonidal cyst is also known as "Jeep disease", due to the fact that, during World War II (1941-1945), several American soldiers (about 80,000) suffered from this disease, because, either they were driving for long hours on uneven, destroyed by war, roads, or, they were spending time sitting at military vehicles like jeep, trucks and tankers, resulting in being submitted to surgical operation, in order to alleviate the arousing pilonidal cyst problem, at USA military hospitals.

Pilonidal cyst, is considered as one of the most common diseases of the subcutaneous tissues of the sacrococcygeal region. This situation is the result of hair penetrating into the skin, a situation not uncommon in this anatomical area. In a study including 50,000 college students, pilonidal cyst occurrence, in males, was 1.1%, which was 10 times higher compared to females, although a considerable rate of them was asymptomatic. Evidence from studies in England, also, indicate that the disease is more frequent in men than women (1 to 3) . The disease is more common in Caucasians than in Asians or Africans due to the differences in their hair characteristics and the respective hair development pattern. Risk factors include the following: sedentary life (44%), positive family history (38%), obesity (50%) and regional irritation (34%). The disease usually presents during the age of 16 - 20 and prevalence is decreasing drastically after the 25th year of age. This disease rarely develops before the adolescence and after the 40th year of age.

Treatment usually depends on the condition of the disease. An acute abscess is usually controlled with incision and drainage. A chronic pilonidal cyst is best treated with a surgical procedure that involves complete resection of the cyst along with the coexisting fistulas, in order to ensure the minimum reoccurrence rate. There are two choices after surgical resection, secondary intention wound healing or primary trauma closure, with or without a flap. The surgical procedure can be performed with the administration of local anaesthesia in the outpatient office or in a day-clinic, or with the use of general anaesthesia depending on the condition of the patient.

Post operatively secondary intention wound healing is applied in many cases, especially when factors like infection, necrotic tissue or inflammatory tissue are introduced. There are many dressings that can be used for the care of a surgical trauma. The ideal dressing used should have some special characteristics such as absorption of exudates without leakage, provision of a dry environment that prevents bacteria from entering the wound and facilitation of easy appliance, as well as removal. Choosing the right dressing is not based on a certain protocol, but mostly on the surgeon preference.

The current study aims at comparing two groups of patients that will be subjected to surgical resection of pilonidal cyst and secondary intention wound healing. In the first group, dressings like alginate cord with silver and high G cellulose will be used for filling of the wound cavity and a hydro-capillary dressing for sealing and waterproofing the wound. In the other group, simple gauze dressings for the coverage of the wound cavity will be used. Comparison of the two groups will involve all the endpoints that indicate whether such dressings can facilitate faster wound healing, enabling, thus, patients to faster return to their everyday activities. Furthermore, a parameter that has not been, previously, studied, the quality of life after the surgical excision of the pilonidal cyst, by using the SF - 36 and the Quality of life with Chronic Wound questionnaire, will, also, be investigated.

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 (Investigator, Outcomes Assessor)

盲法说明

Blinding will exist at the level of the investigator who will record the data postoperatively. There will be no blinding at the level of the surgeon or the patient.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Pilonidal cyst
  • Age: 18 to 80 years
  • American Society of Anesthesiologists (ASA) score: I, II, III, IV
  • Disease stage I,II,III and IV

排除标准

  • Pilonidal abscess
  • Patient age ≥ 80 years or < 18 years
  • Pilonidal abscess

结局指标

主要结局

Wound healing time

时间窗: Maximum time frame 50 days postoperatively

Postoperative required time for wound healing. Measurement unit: days

次要结局

  • Treatment satisfaction(35 days postoperatively)
  • Treatment acceptance(35 days postoperatively)
  • Postoperative analgesics consumption(7, 14, 21, 28, 35, 42 and 49 days postoperatively)
  • Difference in the quality of life of the patient(7, 14 and 21 days potoperatively)
  • Postoperative return to everyday activities(Maximum time frame 50 days postoperatively)
  • Cost of the material(Maximum time frame 50 days postoperatively)
  • Medium term quality of life(28 days postoperatively)
  • Postoperative pain level(7, 14, 21, 28, 35, 42 and 49 days postoperatively)
  • Overall satisfaction level(50 days postoperatively)
  • Wound care visits(7, 14, 21, 28, 35, 42 and 49 days postoperatively)
  • Wound contamination(Maximum time frame 50 days postoperatively)
  • Wound haematoma(Maximum time frame 50 days postoperatively)
  • Trauma secretions(7, 14, 21, 28, 35, 42 and 49 days postoperatively)
  • Wound erythema(Maximum time frame 50 days postoperatively)
  • Disease recurrence(Maximum time frame 1 year postoperatively)

研究者

发起方
Larissa University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mamaloudis Ioannis

Principal Investigator

Larissa University Hospital

研究点 (2)

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