Prospective Randomized Controlled Trial of Skin Closure Techniques in Oncological Cranial Neurosurgery: Interrupted Transdermal Sutures and Running Intradermal Suture.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Occurrence of surgical wound healing complication.
研究概览
简要总结
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.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years old
- •Qualified for a craniotomy due to supratentorial intracranial tumor
排除标准
- •Revision surgery due to recurrent brain tumor
- •Emergency neurosurgical procedure
- •Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)
研究组 & 干预措施
Subjects receiving non-absorbable interrupted transdermal sutures
干预措施: Non-absorbable interrupted transdermal suture (Other)
Subjects receiving absorbable running intradermal sutures
干预措施: Absorbable running intradermal suture (Other)
结局指标
主要结局
Occurrence of surgical wound healing complication.
时间窗: From enrollment to the final wound assessment time point - 90 days postoperatively.
The primary outcome of this trial is the occurrence of surgical wound healing complication including wound dehiscence (defined as separation of wound edges longer than 1 cm), surgical site infection or external cerebrospinal fluid leak.
次要结局
- Aesthetic quality of wound healing - observer perspective.(From enrollment to the final wound assessment time point - 90 days postoperatively.)
- Aesthetic quality of wound healing - patient perspective.(From enrollment to the final wound assessment time point - 90 days postoperatively.)
- Aesthetic quality of wound healing - observer perspective.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Aesthetic quality of wound healing - patient perspective.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Pain or discomfort related to sutures removal(At the time of non-absorbable sutures removal - typically 7-10 days postoperatively.)
- Incidence and nature of additional interventions - invasive interventions - sutures.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Incidence and nature of additional interventions - invasive interventions - lumbar drainage.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Incidence and nature of additional interventions - invasive interventions - secondary surgical intervention.(From enrollment to the final woun assessment timepoint - 90 days postoperatively.)
- Incidence and nature of additional interventions - conservative management(From enrollment to the final wound assessment timepoint - 90 days postoperatively)
- Incidence of external cerebrospinal fluid leak(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Surgical site infections - deep infections.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Surgical site infections - superficial infections requiring hospitalization.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Surgical site infections - superficial infections not requiring hospitalization.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Economic Evaluation - cost of materials used for interrupted skin closure.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)
- Economic Evaluation - cost of materials used for continuous skin closure.(From enrollment to the final wound assessment timepoint - 90 days postoperatively.)