PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
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, Standard Wound Dressing.
- Кому может быть актуально
- Состояния в реестре: Wound Surgical, Wound Infection, Cosmesis. 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
Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
Обзор
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Подробное описание
Many factors influence the risk of wound complications. Notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. Patient factors such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are non-modifiable, particularly in the short-term setting. However, surgical factors may be altered in an effort to reduce the risk of wound complications.
One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion. The type of dressing may influence factors such as bacterial access to the wound, the development of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively, these wound factors increase the risk of wound infection. Therefore, dressings which reduce these factors have the potential to reduce wound breakdown, thereby reducing the burden for patients and healthcare systems.
The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence, wound healing complications and scar appearance, patient quality of life and financial impact on the patient and healthcare system.
Вмешательства
- Устройство Negative Pressure Wound Therapy
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation - Устройство Standard Wound Dressing
Application of standard wound dressing post major lower extremity amputation
Первичные конечные точки
- Presence of wound complications following amputation between NPWT and standard dressings [Срок оценки: 1 month following surgery]
Вторичные конечные точки (12)
- Number of days to discharge [Срок оценки: 6 months following surgery]
- Rate of re-admission [Срок оценки: 1 Month following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: Baseline]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 1 month following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 3 months following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Срок оценки: 6 months following surgery]
- Wound-QoL (Questionnaire on quality of life with chronic wounds) [Срок оценки: 1 month following surgery]
- Wound-QoL (Questionnaire on quality of life with chronic wounds) [Срок оценки: 3 months following surgery]
- Wound-QoL (Questionnaire on quality of life with chronic wounds) [Срок оценки: 6 months following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Срок оценки: 1 Month following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Срок оценки: 3 Months following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Срок оценки: 6 Months following surgery]
Критерии участия
Критерии включения
- Patients aged 18 years or older;
- Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
- Patients with primary closure of the surgical incision using either interrupted or continuous sutures
Критерии исключения
- Patients <18 years;
- Women who are pregnant and/or breast-feeding;
- Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
- Patients with amputations where skin glue is the only means of skin closure
- Patients with a clinically absent femoral pulse
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Ирландия · 7 центров
- Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0 — Dublin
- St James's Hospital — Dublin
- St Vincents University Hospital — Dublin
- Tallaght University Hospital — Dublin
- University Hospital Galway — Galway
- University Hospital Limerick — Limerick
- University Hospital Waterford — Waterford
Идентификаторы
NCT: NCT06025253 · RCSI- PINTA