Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Absorbable running intradermal suture, Non-absorbable interrupted transdermal suture.
- Who it may be relevant to
- Registry conditions: Brain Tumor Adult, Brain Tumor Benign, Meningioma, Glioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Randomized Controlled Trial of Skin Closure Techniques in Oncological Cranial Neurosurgery: Interrupted Transdermal Sutures and Running Intradermal Suture.
Overview
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.
Interventions
- Other Absorbable running intradermal suture
Absorbable sutures used to perform continuous/running intradermal skin closure. - Other Non-absorbable interrupted transdermal suture
Non-absorbable sutures used to perform interrupted transdermal skin closure.
Primary outcome measures
- Occurrence of surgical wound healing complication. [Time frame: From enrollment to the final wound assessment time point - 90 days postoperatively.]
Secondary outcome measures (12)
- Aesthetic quality of wound healing - observer perspective. [Time frame: From enrollment to the final wound assessment time point - 90 days postoperatively.]
- Aesthetic quality of wound healing - patient perspective. [Time frame: From enrollment to the final wound assessment time point - 90 days postoperatively.]
- Aesthetic quality of wound healing - observer perspective. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Aesthetic quality of wound healing - patient perspective. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Pain or discomfort related to sutures removal [Time frame: At the time of non-absorbable sutures removal - typically 7-10 days postoperatively.]
- Incidence and nature of additional interventions - invasive interventions - sutures. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Incidence and nature of additional interventions - invasive interventions - lumbar drainage. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Incidence and nature of additional interventions - invasive interventions - secondary surgical intervention. [Time frame: From enrollment to the final woun assessment timepoint - 90 days postoperatively.]
- Incidence and nature of additional interventions - conservative management [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively]
- Incidence of external cerebrospinal fluid leak [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Surgical site infections - deep infections. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
- Surgical site infections - superficial infections requiring hospitalization. [Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.]
Eligibility criteria
Inclusion criteria
- Male or female at least 18 years old
- Qualified for a craniotomy due to supratentorial intracranial tumor
Exclusion criteria
- Revision surgery due to recurrent brain tumor
- Emergency neurosurgical procedure
- Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Department of Neurosurgery of Medical University of Warsaw — Warsaw
Identifiers
NCT: NCT07413796 · KB/124/25