Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures (NEURO-SUTURE)

May 19, 2026 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-097
        • Recruiting
        • Department of Neurosurgery of Medical University of Warsaw
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects receiving absorbable running intradermal sutures
Other: Absorbable running intradermal suture
Absorbable sutures used to perform continuous/running intradermal skin closure.
Active Comparator: Subjects receiving non-absorbable interrupted transdermal sutures
Other: Non-absorbable interrupted transdermal suture
Non-absorbable sutures used to perform interrupted transdermal skin closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of surgical wound healing complication.
Time Frame: 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.
From enrollment to the final wound assessment time point - 90 days postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic quality of wound healing - observer perspective.
Time Frame: From enrollment to the final wound assessment time point - 90 days postoperatively.
Aesthetic quality of postoperative wound/scar, evaluated using the Patient and Observer Scar Assessment Scale (from 9 to 45 points for Observer score) where higher scores indicate worse healing outcomes.
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 postoperative wound/scar, evaluated using the Patient and Observer Scar Assessment Scale (from 17 to 85 points for Patient score) where higher scores indicate worse healing outcomes.
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 postoperative wound/scar using Visual Analogue Scale (from 1 to 10 pints) in observer's perspective where higher score indicates better wound healing outcomes.
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.
Aesthetic quality of postoperative wound/scar using Visual Analogue Scale (from 1 to 10 points) in patient's perspective where higher score indicates better wound healing outcomes.
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.
Pain/discomfort during sutures removal assessed using Visual Analogue Scale (from 1 to 10 points) among subjects receiving non-absorbable sutures where higher score stands for the worst pain ever felt.
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 invasive interventions due to suboptimal wound/scar formation:

- placement of additional sutures within the wound. Amount of sutures added and timing of sutures placement after primary surgical intervention.
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 invasive interventions due to suboptimal wound/scar formation:

- lumbar drainage placement Timing of lumbar drainage placement after primary surgical intervention and it's duration.
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 invasive interventions due to suboptimal wound/scar formation:

- secondary surgical intervention (re-operation). Timing of secondary surgical intervention after primary surgical intervention.
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 and nature of additional conservative management interventions due to suboptimal wound/scar formation, such as: antibiotic therapy and/or pharmacologic therapy - type of drugs used for management and it's duration.
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.
Incidence of cerebrospinal fluid leakage through the wound margins.
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.
Incidence of deep surgical site infections, based on clinical and/or radiologic evaluation, such as epidural/subdural empyema, intracranial abscess.
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.
Incidence of superficial surgical site infections, based on clinical and/or radiologic evaluation such as skin erythema, swelling, tenderness, purulent/serous discharge skin necrosis that require hospitalization. Evaluation of timing of infections diagnoses after primary surgical intervention.
From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Surgical site infections - superficial infections not requiring hospitalization.
Time Frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Incidence of superficial surgical site infections, based on clinical and/or radiologic evaluation such as skin erythema, swelling, tenderness, purulent/serous discharge skin necrosis that do not require hospitalization. Evaluation of timing of infections diagnoses after primary surgical intervention.
From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Economic Evaluation - cost of materials used for interrupted skin closure.
Time Frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Cost of materials used in patients whose skin was closed using interrupted non-absorbable sutures.
From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Economic Evaluation - cost of materials used for continuous skin closure.
Time Frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Costs of skin closure materials used in patients whose skin was closed using using the continuous absorbable suture.
From enrollment to the final wound assessment timepoint - 90 days postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/124/25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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