Fixing the galea aponeurotica may be an advantageous strategy compared to conventional closure in Pterional Craniotomies in elective surgeries

Subgaleal anchorage versus conventional closure in patients undergoing pterional craniotomy in elective surgeries: a randomized controlled clinical trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-6kd4f39

Enrollment

Unknown

Registered

2025-10-02

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Interventions

This is a randomized controlled clinical study with two arms, double-blind. Experimental group with 20 patients undergoing Pterional Craniotomy with the thermal subgaleal anchoring technique of the su

E04.987

C23.550.767.887

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who will undergo Pterional Craniotomy, regardless of the etiology of the lesion to be operated on; both sexes; age over 18 years; level of consciousness adequate to assess postoperative pain

Exclusion criteria

Exclusion criteria: Patients who have already undergone a previous Craniotomy; patients who have infection or trauma at the same incision site prior to Surgery; patients who chronically suffer from Facial Pain

Design outcomes

Primary

Measure	Time frame
To assess whether there will be less postoperative pain in the intervention group, determined by applying the Visual Analogue Scale (VAS) serially, daily, in the first 72 hours and after 14 days postoperatively	—

Secondary

Measure	Time frame
To assess whether there will be a lower incidence of cerebrospinal fluid leaks in the intervention group, determined by the patient's clinical parameters and daily analysis of the surgical wound;To assess whether there will be less surgical wound infection in the intervention group, determined by physical examination and laboratory tests performed daily on patients;Assess whether there will be a shorter hospital stay in the intervention group, determined by analyzing the patients' medical records;To assess whether there will be a lower thickness of soft tissue edema in surgical wounds (subgaleal collection volume) in the intervention group, determined by means of a soft tissue tomographic study;To assess whether there was less use of opioids in the intervention group, determined by analyzing the patients' medical records	—

Measure

Time frame

To assess whether there will be a lower incidence of cerebrospinal fluid leaks in the intervention group, determined by the patient's clinical parameters and daily analysis of the surgical wound;To assess whether there will be less surgical wound infection in the intervention group, determined by physical examination and laboratory tests performed daily on patients;Assess whether there will be a shorter hospital stay in the intervention group, determined by analyzing the patients' medical records;To assess whether there will be a lower thickness of soft tissue edema in surgical wounds (subgaleal collection volume) in the intervention group, determined by means of a soft tissue tomographic study;To assess whether there was less use of opioids in the intervention group, determined by analyzing the patients' medical records

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Countries

Brazil

Contacts

Public ContactWesley da Silva

Hospital Universitário Getúlio Vargas da Universidade Federal do Amazonas

wesleylopeswls@gmail.com+55 (67) 981143889

Outcome results

None listed

Source: REBEC (via WHO ICTRP)