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To study use of N- Acetylcysteine (NAC) as an adjunct therapy in the management of lower extremity vascular injuries

To evaluate the impact of N-Acetylcysteine (NAC) use in the treatment of traumatic lower extremity vascular injury â?? A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052257
Enrollment
80
Registered
2023-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: S759- Injury of unspecified blood vesselat hip and thigh level Health Condition 2: S859- Injury of unspecified blood vesselat lower leg level

Interventions

Intervention1: N-Acetylcysteine (NAC) GROUP-A: 5 days N-acetylcysteine 20% 1200 mg in 100ml DNS iv bd over 30 â?? 60 mins Control Intervention1: Placebo: Dextrose Normal Saline 100ml iv twice daily o

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Traumatic lower extremity vascular injury in whom upfront amputation is not planned

Exclusion criteria

Exclusion criteria: •Paediatric patients of age •Pregnant or lactating women •Patients with known, pre-existent asthma or allergies, malignancy, diabetes or immunocompromised patients •Patients who have not consented for the study

Design outcomes

Primary

MeasureTime frame
1.To compare the limb salvageability rate at 30 days post injury between NAC treatment group and the placebo group. Timepoint: 30 DAYS LIMB SALVAGEABILITY

Secondary

MeasureTime frame
Wound healing Surgical site infection rate Wound closure rateTimepoint: 30 days

Countries

India

Contacts

Public ContactShankarnath S

JaiPrakash Narayan Apex Trauma Centre

dr_bagaria@yahoo.co.in9914201918

Outcome results

None listed

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