ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Negative Pressure Wound Therapy.
- Кому может быть актуально
- Состояния в реестре: Pilonidal Sinus, Wound Healing. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Ирландия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Excision and Negative Pressure Wound Therapy Versus Excision and Leaving Open With Standard Wound Care for Management of Chronic Pilonidal Sinus Disease - A Randomised Controlled Trial
Обзор
This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).
Подробное описание
Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males.
PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery.
The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.
Вмешательства
- Устройство Negative Pressure Wound Therapy
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Первичные конечные точки
- Time to complete wound healing [Срок оценки: 6 months post surgery]
Вторичные конечные точки (12)
- Measure of post operative pain [Срок оценки: 6 months post surgery]
- Measure of post operative complications [Срок оценки: 6 months post surgery]
- Measure of quality of life [Срок оценки: 6 months post surgery]
- To investigate resource use [Срок оценки: 6 months post surgery]
- To compare recurrence rates [Срок оценки: 6 months post surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 1 month]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 3 months]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 6 months]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: 1 month]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: 3 months]
- Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS) [Срок оценки: 6 months]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Срок оценки: 1 Month]
Критерии участия
Критерии включения
i) They are aged 18 years or older
ii) They are undergoing elective pilonidal sinus excision without primary closure
Критерии исключения
i) They are unable to adhere to protocol requirements e.g. questionnaire completion
ii) They are undergoing emergency drainage for a pilonidal abscess
iii) They are undergoing surgery for a pilonidal sinus disease in locations other than the natal cleft
iv) They have underlying osteomyelitis
v) They have underlying fistulating disease e.g. Crohn's
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Ирландия · 10 центров
- Beaumont Hospital — Dublin
- Mayo University Hospital — Castlebar
- St James's Hospital — Dublin
- St Michael's Hospital Dun Laoighre — Dublin
- St Vincent's Hospital — Dublin
- Tallaght University Hospital — Dublin
- St. Luke's Hospital — Kilkenny
- University Hospital Limerick — Limerick
- … и ещё 2 центра
Идентификаторы
NCT: NCT06647290 · RCSI-ENVELOP