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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving absorbable running intradermal sutures | Experimental |
| |
| Subjects receiving non-absorbable interrupted transdermal sutures | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Absorbable running intradermal suture | Other | Absorbable sutures used to perform continuous/running intradermal skin closure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the final wound assessment time point - 90 days postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michał Senger, M.D. | Contact | +48 791 760 040 | michal.senger@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery of Medical University of Warsaw | Recruiting | Warsaw | Masovian Voivodeship | 02-097 | Poland |
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Prospective interventional trial with randomization.
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| Non-absorbable interrupted transdermal suture | Other | Non-absorbable sutures used to perform interrupted transdermal skin closure. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the final wound assessment timepoint - 90 days postoperatively. |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D008579 | Meningioma |
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D001254 | Astrocytoma |
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