A STUDY TO COMPARE TWO SURGICAL TECHNIQUES OF DURAL CLOSURE AMONG PATIENTS UNDERGOING DECOMPRESSIVE CRANIECTOMY IN TRAUMATIC BRAIN INJURY

DURAPLASTY VERSUS SURGICELOPLASTY IN TRAUMATIC DECOMPRESSIVE CRANIECTOMY: A RANDOMIZED CONTROLLED TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066972

Enrollment

260

Registered

2024-05-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Health Condition 1: S06- Intracranial injury

Interventions

Intervention1: DURAPLASTY: Watertight lax duraplasty will be performed in the control group. A follow-up CT will be obtained between days 5-10th post-op day and the patient will be assessed for outcom

Eligibility

Inclusion criteria

Inclusion criteria: Patients of TBI undergoing DC with age Patients with complete clinical data and follow-up details.

Exclusion criteria

Exclusion criteria: Patient with intraaxial contusion or hematoma requiring surgical evacuation. Patients with incomplete clinical data or follow up details.

Design outcomes

Primary

Measure	Time frame
To study incidence of complications, namely 1. CSF leak (CSF drainage through surgical wound) 2. Subgaleal fluid collections (CSF drainage to the subcutaneous/epidural space, but not through surgical wound) 3. Surgical site infection (limited to the subcutaneous/ epidural space; not involving the brain parenchyma) 4. Meningitis, Ventriculitis, Brain abscess (infection involving the brain parenchyma). Timepoint: ZERO, 7TH AND 90TH POSTOPERATIVE DAY	—

Measure

Time frame

To study incidence of complications, namely 1. CSF leak (CSF drainage through surgical wound) 2. Subgaleal fluid collections (CSF drainage to the subcutaneous/epidural space, but not through surgical wound) 3. Surgical site infection (limited to the subcutaneous/ epidural space; not involving the brain parenchyma) 4. Meningitis, Ventriculitis, Brain abscess (infection involving the brain parenchyma). Timepoint: ZERO, 7TH AND 90TH POSTOPERATIVE DAY

—

Secondary

Measure	Time frame
1. To study the clinical outcomes using Glasgow Outcome scale (GOS) at 3 months. 2. Time taken to completion of surgery. 3. The amount of intra-operative blood loss. 4 The duration of hospital stay Timepoint: 3 MONTHS	—

Countries

India

Contacts

Public ContactRAMESH DODDAMANI

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

drsdramesh@gmail.com9599043707

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026