Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures

Официальное название

Prospective Randomized Controlled Trial of Skin Closure Techniques in Oncological Cranial Neurosurgery: Interrupted Transdermal Sutures and Running Intradermal Suture.

Обзор

The purpose of this study is to compare two commonly used methods of closing the skin after surgery for an intracranial tumor. Skin closure is one of the most important steps in neurosurgical procedures, as it has a major influence on how well the wound heals. In patients with brain tumors, proper wound healing is especially important because it may affect how soon additional treatments, such as radiotherapy or chemotherapy, can be started. There are different ways to close the skin after surgery, including running sutures and interrupted sutures. Both methods are widely used and considered safe. However, in oncological neurosurgery, there is limited scientific evidence comparing their effects, and the choice of technique is often based on the surgeon's personal experience. In this study, investigators will compare skin closure using running absorbable sutures with interrupted non-absorbable sutures. Investigators will evaluate how well, depending on used suturing methods, the wound heals and how often wound-related complications occur, such as infection, separation of the wound edges, or leakage of cerebrospinal fluid. Investigators believe that the results of this study will help improve wound care in patients undergoing neurosurgical treatment for brain tumors and, as a result, may contribute to better recovery and overall quality of life.

Вмешательства

• Другое Absorbable running intradermal suture
  Absorbable sutures used to perform continuous/running intradermal skin closure.
• Другое Non-absorbable interrupted transdermal suture
  Non-absorbable sutures used to perform interrupted transdermal skin closure.

Первичные конечные точки

• Occurrence of surgical wound healing complication. [Срок оценки: From enrollment to the final wound assessment time point - 90 days postoperatively.]

Вторичные конечные точки (12)

• Aesthetic quality of wound healing - observer perspective. [Срок оценки: From enrollment to the final wound assessment time point - 90 days postoperatively.]
• Aesthetic quality of wound healing - patient perspective. [Срок оценки: From enrollment to the final wound assessment time point - 90 days postoperatively.]
• Aesthetic quality of wound healing - observer perspective. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Aesthetic quality of wound healing - patient perspective. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Pain or discomfort related to sutures removal [Срок оценки: At the time of non-absorbable sutures removal - typically 7-10 days postoperatively.]
• Incidence and nature of additional interventions - invasive interventions - sutures. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Incidence and nature of additional interventions - invasive interventions - lumbar drainage. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Incidence and nature of additional interventions - invasive interventions - secondary surgical intervention. [Срок оценки: From enrollment to the final woun assessment timepoint - 90 days postoperatively.]
• Incidence and nature of additional interventions - conservative management [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively]
• Incidence of external cerebrospinal fluid leak [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Surgical site infections - deep infections. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
• Surgical site infections - superficial infections requiring hospitalization. [Срок оценки: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]

Критерии участия

Критерии включения

• Male or female at least 18 years old
• Qualified for a craniotomy due to supratentorial intracranial tumor

Критерии исключения

• Revision surgery due to recurrent brain tumor
• Emergency neurosurgical procedure
• Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)

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

Польша · 1 центр

• Department of Neurosurgery of Medical University of Warsaw — Warsaw

Идентификаторы

NCT: NCT07413796 · KB/124/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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