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NCT Number: NCT07413796

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

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.

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Key information

Conditions

Brain Tumor Adult Astrocytoma Brain Diseases Brain Neoplasms Brain Tumor Benign Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioma Meningeal Neoplasms Meningioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery of Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location status: Recruiting

Location contact

Michał Senger, M.D.

CONTACT

[email protected]

+48 791 760 040

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Absorbable running intradermal suture

Other

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

Non-absorbable interrupted transdermal suture

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michał Senger, M.D.

CONTACT

[email protected]

+48 791 760 040

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Acronym: NEURO-SUTURE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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