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

NCT07413796 | Recruiting

• 1 other identifier: KB/124/25
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor Adult; Brain Tumor Benign; Meningioma; Glioma; Glioblastoma

Keywords

skin closure; brain tumor; intracranial tumor; glioma; meningioma

Outcome Measures

Primary Outcomes (1)

• Occurrence of surgical wound healing complication.

  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.

  From enrollment to the final wound assessment time point - 90 days postoperatively.

Secondary Outcomes (15)

• 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.

Study Arms (2)

Subjects receiving absorbable running intradermal sutures

EXPERIMENTAL

Other: Absorbable running intradermal suture

Subjects receiving non-absorbable interrupted transdermal sutures

ACTIVE COMPARATOR

Other: Non-absorbable interrupted transdermal suture

Interventions

Absorbable running intradermal suture OTHER

Absorbable sutures used to perform continuous/running intradermal skin closure.

Subjects receiving absorbable running intradermal sutures

Non-absorbable interrupted transdermal suture OTHER

Non-absorbable sutures used to perform interrupted transdermal skin closure.

Subjects receiving non-absorbable interrupted transdermal sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Neurosurgery of Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Meningioma; Glioma; Glioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Astrocytoma

Study Officials

• Michał Senger, M.D.

  Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

• Tomasz A Dziedzic, M.D. Phd

  Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michał Senger, M.D.

CONTACT

+48 791 760 040; michal.senger@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective interventional trial with randomization.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-01

Locations

PL (1)