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A randomized controlled trial comparing methods of bone flap preservation for cranioplasty in cases of traumatic brain injury

A randomized controlled trial comparing the use of cryopreserved and subcutaneously preserved bone flaps for cranioplasty in cases of traumatic brain injury to assess the rates of postoperative surgical site infection and neurological outcomes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28031894
Enrollment
100
Registered
2025-01-24
Start date
2023-06-22
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Patients with traumatic brain injury who need to undergo decompressive craniectomy Injury, Occupational Diseases, Poisoning

Interventions

After written informed consent from the patient or guardian of the patient who is planned for decompressive craniectomy following traumatic brain injury, the patient is allocated into one of the two g

Sponsors

All India Institute of Medical Sciences, Patna
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients who undergo decompressive craniectomy following traumatic brain injury during the approved period in All India Institute of Medical Sciences, Patna 2. Patients who have provided written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: 1. Patients presenting with shock due to trauma on initial presentation 2. Patients with additional indication of exploratory laparotomy 3. Patients with loss of scalp skin and soft tissue on the side of decompressive craniectomy. 4. Patients who have loss of skin or soft tissue involving both anterior abdominal wall and lateral aspect of both thighs 5. Preexisting loco-regional infections involving both anterior abdominal wall and both thighs on the day of decompressive craniectomy 6. Patients with loco-regional infections at the flap site or osteomyelitis of cranium 7. Patients who have developed proven brain abscess or meningitis 8. Patients who underwent decompression due to causes other than trauma 9. Bilateral cranial defects 10. History of radiation therapy 11. Patients with general operative contraindications and bleed dyscrasias

Design outcomes

Primary

MeasureTime frame
1. Surgical site infection is assessed as "Yes" or "No" using clinical examination with the presence of surgical site infection defined by National Healthcare Safety Network Criteria on day 7 and day 30 2. Neurological outcome is measured using the Glasgow Outcome Score measured at baseline, day 7 and day 30

Secondary

MeasureTime frame
1. Drain output is measured in milliliters using a measuring cup on day 1 2. Seroma is assessed as "Yes" or "No" using the clinical presence of subgaleal fluctuation (physical examination) on day 7 and day 30 3. Re-operation is assessed as "Yes" or "No", defined by the presence of additional surgical interventions from the day of cranioplasty to day 30

Countries

India

Contacts

Public ContactRachith Sridhar
rachith10862@aiimspatna.org+91 (0)8147508584

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026