RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Cicatrization
研究概览
简要总结
Pilonidal Sinus PS is a prevalent disease in young patients. There is currently no consensus on the surgical treatment of choice. Each method is associated with different advantages and disadvantages, as well as different recurrence rates. The ideal treatment should reduce morbidity, be associated with a short hospital stay (outpatient surgery), promote rapid healing, early return to work, and have a low recurrence rate. To date, no technique meets all these criteria. However, the NPT could meet them. The use of NPT in PS could decrease healing time, achieving an early return to work. In addition, it would avoid the need for daily dressings, which would mean lower hospital costs. However, the location of the wound (sacrum) and its proximity to the anal margin mean that its use cannot be generalized.
Although two retrospective series have recently reported good results with the use of NPT in PS, a prospective, randomized study is needed to compare healing time, recurrence rates, hospital costs, and assess quality of life for determine if this could be the treatment of choice.
Although NPT is commonly used in clinical practice (being useful in closing complex wounds, with devitalized tissues, burns and wounds with exposed tendons), to date there is not enough evidence to support its use after flattening the PS and it is for this reason that we conducted this study.
In this project there is a total absence of commercial interest in the proposal. No project related to the proposed one is currently being carried out.
详细描述
The study population will be made up of all patients with PS admitted to the General and Digestive Surgery service of the Hospital Universitari de Bellvitge from the start of the trial until the end of recruitment, and who meet the inclusion criteria.
Once the patients belonging to the population of interest have been identified, they will propose to participate in the clinical trial, providing complete information, as well as an information sheet with the details of the study. If you agree, the informed consent document will be provided for your signature and randomization will proceed.
Bitter et al. observed in a prospective study that the use of NTP did not reduce healing time compared to conventional closure 84 days (34-349) vs 93 days (43-264); p=0.44. However, the duration of NPT application of only 2 weeks might have been too short to see an adequate effect. Also, the small sample size could have influenced the results. On the other hand, recent publications on the use of TPN in the treatment of pilonidal sinus have shown a significant reduction in healing time (28 days) with minimal complications and adequate patient satisfaction. Taking into account the scarce evidence of the studies cited, we have decided to adopt a conservative criterion, assuming a smaller difference in time to healing between the two treatments (35 days).
To calculate the sample size, the time variable has been transformed into a logarithm. Accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 94 patients, 47 subjects in the control group and 47 in the experimental group, are needed to detect a difference of 0.77. A common standard deviation of 1.26 is assumed. A rate of loss to follow-up of 10% has been estimated.
Randomization 1:1 will be performed using a statistical program at the baseline visit in outpatient clinics 48 hours after surgery, after assessing the dimensions of the wound, checking whether the participant meets the inclusion/exclusion criteria and has signed the informed consent.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients diagnosed with SP (recurrence or not), who have undergone surgery.
- •Minimum depth of the wound 1.5 cm.
排除标准
- •Inferior margin of the surgical wound is located less than 3 cm from the anus
- •Patients under 16 years of age
- •Unable to track
- •Diagnosed psychiatric illness
- •Patients diagnosed with hidradenitis
- •Uncontrolled diabetics
- •Immunocompromised (kidney or liver transplant, chronic treatment with corticosteroids, haematological disease, neoplastic disease undergoing chemotherapy)
结局指标
主要结局
Cicatrization
时间窗: 1 year
Time in days from surgery to complete epithelialization of the wound, assessed by the dressing nurse and surgeon.
次要结局
- Cost effectiveness(1 year)
- Disease recurrence at follow-up(1 year)
- Wound size(1 year)
- Patient satisfaction(1 year)
- Adverse effects related to the treatments(1 year)
- Postoperative pain(1 year)
- Time of incorporation into daily activities(1 year)
- Patient quality of life(1 year)
研究者
Sebastiano Biondo
PhD, MD
Hospital Universitari de Bellvitge