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Идёт набор NCT07439575

Wound Closure Materials and Techniques in Hip and Knee Arthroplasty

Без фазы С лечением Osteoarthritis, Knee Osteoarthritis, Hip

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: Barbed Suture Wound Closure, Conventional Suture Wound Closure.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Knee, Osteoarthritis, Hip. Базовые параметры: от 30 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Different Suture Materials and Closure Techniques in Lower Extremity Arthroplasty: Effects on Wound Healing, Functional Outcomes, and Complications

Обзор

This prospective randomized clinical study aims to evaluate the effects of different suture materials and wound closure techniques on wound healing, functional outcomes, and postoperative complications in patients undergoing total hip and knee arthroplasty. A total of at least 90 adult patients undergoing primary or aseptic revision lower extremity arthroplasty will be randomized into two groups according to the wound closure material and technique used. All surgeries will be performed by the same surgical team following standardized operative protocols. Primary outcomes include wound-related complications such as prolonged wound drainage, wound dehiscence, surgical site infection, and local inflammatory findings within 90 days postoperatively. Secondary outcomes include operative time, bleeding amount, cosmetic outcomes, and functional scores. The results of this study are expected to help determine the most effective and safe wound closure method in lower extremity arthroplasty.

Подробное описание

Total hip and knee arthroplasty are commonly performed surgical procedures in the management of end-stage degenerative joint diseases. Optimal wound closure is critical in reducing postoperative complications such as prolonged wound drainage, wound dehiscence, surgical site infection, and delayed wound healing. Various suture materials and closure techniques are routinely used in clinical practice; however, consensus regarding the most effective method remains limited.

This prospective randomized study is designed to compare different suture materials and wound closure techniques in patients undergoing primary or aseptic revision total hip and knee arthroplasty. Participants will be randomly assigned in a 1:1 ratio to one of two wound closure strategies differing in both suture material and closure technique following total hip or knee arthroplasty. The study aims to determine their effects on wound healing, functional outcomes, and postoperative complications.

A minimum of 90 adult patients will be enrolled. Eligible patients will be randomized into two groups according to the wound closure material and technique used. All surgical procedures will be performed by the same surgical team following standardized perioperative protocols in order to minimize confounding variables.

Preoperative demographic data will be recorded. Intraoperative variables including operative time and intraoperative blood loss will be documented. Postoperative assessments will include wound drainage duration, signs of local inflammation, wound dehiscence, surgical site infection, bleeding complications, and cosmetic evaluation. Functional outcomes will be assessed using validated hip and knee scoring systems where applicable.

Patients will be followed for 90 days postoperatively. All data will be recorded in a secure database and analyzed using appropriate statistical methods. Continuous variables will be assessed for normal distribution and analyzed using parametric or non-parametric tests as appropriate. Categorical variables will be analyzed using Chi-square or Fisher's exact test. Multivariate logistic regression analysis will be performed to identify independent predictors of wound-related complications. A p-value \< 0.05 will be considered statistically significant.

The findings of this study are expected to contribute to the optimization of wound closure strategies in lower extremity arthroplasty and improve postoperative outcomes.

Вмешательства

  • Процедура Barbed Suture Wound Closure
    Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.
  • Процедура Conventional Suture Wound Closure
    Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.

Первичные конечные точки

  • Incidence of wound-related complications within 90 days postoperatively [Срок оценки: Within 90 days after surgery]
Вторичные конечные точки (6)
  • Operative Time [Срок оценки: Intraoperative (Day of surgery)]
  • Intraoperative Blood Loss [Срок оценки: Intraoperative (Day of surgery)]
  • Duration of Postoperative Wound Drainage [Срок оценки: Within 90 days after surgery]
  • Surgical Site Infection Rate [Срок оценки: Within 90 days after surgery]
  • Wound Dehiscence [Срок оценки: Within 90 days after surgery]
  • Functional Outcome Score [Срок оценки: Preoperatively and at 3 months postoperatively]

Критерии участия

Критерии включения

  • Age ≥ 30 years
  • Patients undergoing primary total hip arthroplasty or total knee arthroplasty
  • Patients undergoing aseptic revision total hip or knee arthroplasty
  • Surgery performed by the same surgical team
  • Ability to provide informed consent

Критерии исключения

  • Age < 30 years
  • Patients receiving immunosuppressive therapy
  • Patients with complicated diabetes mellitus
  • Chronic venous insufficiency
  • Peripheral arterial disease
  • Arthroplasty performed due to malignancy
  • Active or previous surgical site infection

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

Turkey (Türkiye) · 1 центр
  • Umraniye Training and Research Hospital — Istanbul

Идентификаторы

NCT: NCT07439575 · WOMBAT-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗