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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female at least 18 years old

Qualified for a craniotomy due to supratentorial intracranial tumor

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Absorbable running intradermal suture

    Other intervention

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

  • Non-absorbable interrupted transdermal suture

    Other intervention

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

Treatment groups

382 Participants
are divided into 2 treatment groups
Group A: Subjects receiving absorbable running intradermal suturesExperimental treatment 1 intervention
Group B: Subjects receiving non-absorbable interrupted transdermal suturesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the final wound assessment time point - 90 days postoperatively.

Secondary outcomes

1

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.

Time frame
From enrollment to the final wound assessment time point - 90 days postoperatively.
2

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.

Time frame
From enrollment to the final wound assessment time point - 90 days postoperatively.
3

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.

Time frame
From enrollment to the final wound assessment timepoint - 90 days postoperatively.
4

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.

Time frame
From enrollment to the final wound assessment timepoint - 90 days postoperatively.

Other outcomes

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