Brain Tumor AdultNEURO-SUTURENCT07413796
Comparison of Skin Closure Techniques in Oncological Neurosurgical Procedures: Intradermal Running Suture Versus Transdermal Interrupted Sutures
A study testing Absorbable running intradermal suture and Non-absorbable interrupted transdermal suture in people with Brain Tumor Adult and Brain Tumor Benign, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult, Brain Tumor Benign, Meningioma
- What is being tested?
- Absorbable running intradermal suture and Non-absorbable interrupted transdermal suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old
- Qualified for a craniotomy due to supratentorial intracranial tumor
Who cannot join
- Revision surgery due to recurrent brain tumor
- Emergency neurosurgical procedure
- Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Neurosurgery of Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-097
Michał Senger, M.D., +48 791 760 040, michal.senger@wum.edu.pl
About this study
Official title: 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.
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, Meningioma, Glioma, Glioblastoma
- Being tested
- Absorbable running intradermal suture, Non-absorbable interrupted transdermal suture
- Keywords
- skin closure, brain tumor, intracranial tumor, glioma, meningioma
- Medical subject headings
- Brain Neoplasms, Meningioma, Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable running intradermal sutureOther
Absorbable sutures used to perform continuous/running intradermal skin closure.
Non-absorbable interrupted transdermal sutureOther
Non-absorbable sutures used to perform interrupted transdermal skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving absorbable running intradermal sutures | Experimental | Not described Receives: Other: Absorbable running intradermal suture |
| Subjects receiving non-absorbable interrupted transdermal sutures | Active comparator | Not described Receives: Other: Non-absorbable interrupted transdermal suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the final wound assessment time point - 90 days postoperatively.
Secondary outcomes (15)
Aesthetic quality of wound healing - observer perspective.
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.
Measured: From enrollment to the final wound assessment time point - 90 days postoperatively.
Aesthetic quality of wound healing - patient perspective.
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.
Measured: From enrollment to the final wound assessment time point - 90 days postoperatively.
Aesthetic quality of wound healing - observer perspective.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Aesthetic quality of wound healing - patient perspective.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Pain or discomfort related to sutures removal
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.
Measured: At the time of non-absorbable sutures removal - typically 7-10 days postoperatively.
Incidence and nature of additional interventions - invasive interventions - sutures.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Incidence and nature of additional interventions - invasive interventions - lumbar drainage.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Incidence and nature of additional interventions - invasive interventions - secondary surgical intervention.
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.
Measured: From enrollment to the final woun assessment timepoint - 90 days postoperatively.
Incidence and nature of additional interventions - conservative management
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively
Incidence of external cerebrospinal fluid leak
Incidence of cerebrospinal fluid leakage through the wound margins.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Surgical site infections - deep infections.
Incidence of deep surgical site infections, based on clinical and/or radiologic evaluation, such as epidural/subdural empyema, intracranial abscess.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Surgical site infections - superficial infections requiring hospitalization.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Surgical site infections - superficial infections not requiring hospitalization.
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.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Economic Evaluation - cost of materials used for interrupted skin closure.
Cost of materials used in patients whose skin was closed using interrupted non-absorbable sutures.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Economic Evaluation - cost of materials used for continuous skin closure.
Costs of skin closure materials used in patients whose skin was closed using using the continuous absorbable suture.
Measured: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective interventional trial with randomization.
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michał Senger, M.D., Principal investigator, Department of Neurosurgery, Medical University of Warsaw, Warsaw, PolandTomasz A Dziedzic, M.D. Phd, Principal investigator, Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413796
- Sponsor's protocol ID
- KB/124/25
- Acronym
- NEURO-SUTURE
- Status last verified
- Jan 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Skin Closure Techniques in Oncological Cranial Neurosurgery: Interrupted Transdermal Sutures and Running Intradermal Suture.
- ClinicalTrials.gov ID
- NCT07413796
- Acronym / sponsor ID
- NEURO-SUTURE / KB/124/25
- Conditions
- Brain Tumor Adult, Brain Tumor Benign, Meningioma, Glioma, Glioblastoma
- Keywords
- skin closure, brain tumor, intracranial tumor, glioma, meningioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective interventional trial with randomization.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female at least 18 years old
- Qualified for a craniotomy due to supratentorial intracranial tumor
Key exclusion criteria (3 listed)
- Revision surgery due to recurrent brain tumor
- Emergency neurosurgical procedure
- Scalp incision involving glabrous skin (e.g. forehead) or facial regions (e.g. eyebrow)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable running intradermal sutureAbsorbable sutures used to perform continuous/running intradermal skin closure. | Other | Subjects receiving absorbable running intradermal sutures |
| Non-absorbable interrupted transdermal sutureNon-absorbable sutures used to perform interrupted transdermal skin closure. | Other | Subjects receiving non-absorbable interrupted transdermal sutures |
Primary outcome
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.
15 secondary outcomes
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.
Surgical site infections - superficial infections not requiring hospitalization.
Time frame: 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.
Economic Evaluation - cost of materials used for continuous skin closure.
Time frame: From enrollment to the final wound assessment timepoint - 90 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michał Senger, M.D. principal investigator
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
Tomasz A Dziedzic, M.D. Phd principal investigator
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable running intradermal suture and Non-absorbable interrupted transdermal suture in people with Brain Tumor Adult and Brain Tumor Benign, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michał Senger, M.D. (+48 791 760 040, michal.senger@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of surgical wound healing complication. (time frame: From enrollment to the final wound assessment time point - 90 days postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.