Brain Tumor Adult, Brain Tumor Benign, Glioblastoma, Glioma, Meningioma
Conditions
Keywords
skin closure, brain tumor, intracranial tumor, glioma, meningioma
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.
Interventions
OTHERAbsorbable running intradermal suture
Absorbable sutures used to perform continuous/running intradermal skin closure.
OTHERNon-absorbable interrupted transdermal suture
Non-absorbable sutures used to perform interrupted transdermal skin closure.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective interventional trial with randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of surgical wound healing complication. | 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
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic quality of wound healing - observer perspective. | 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. |
| Aesthetic quality of wound healing - patient perspective. | 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. |
| Pain or discomfort related to sutures removal | 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. |
| Incidence and nature of additional interventions - invasive interventions - sutures. | 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. |
| Incidence and nature of additional interventions - invasive interventions - lumbar drainage. | 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. |
| Incidence and nature of additional interventions - invasive interventions - secondary surgical intervention. | 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. |
| Incidence and nature of additional interventions - conservative management | 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. |
| Incidence of external cerebrospinal fluid leak | From enrollment to the final wound assessment timepoint - 90 days postoperatively. | Incidence of cerebrospinal fluid leakage through the wound margins. |
| Surgical site infections - deep infections. | 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. |
| Surgical site infections - superficial infections requiring hospitalization. | 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. |
| Surgical site infections - superficial infections not requiring hospitalization. | 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. |
| Economic Evaluation - cost of materials used for interrupted skin closure. | 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. |
| Economic Evaluation - cost of materials used for continuous skin closure. | 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. |
Countries
Poland
Contacts
CONTACTMichał Senger, M.D.
PRINCIPAL_INVESTIGATORMichał Senger, M.D.
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
PRINCIPAL_INVESTIGATORTomasz A Dziedzic, M.D. Phd
Department of Neurosurgery, Medical University of Warsaw, Warsaw, Poland
Outcome results
None listed