Investigation of the Effect of Systemic Steroids on Treatment and Prevention of Recurrent Tracheal Stenosis in Postoperative Patients

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

tracheal stenosis is the result of abnormal wound-healing processes leading to hypertrophic scar formation and obstruction of the airway lumen by excess granulation tissue. This process is progressive so treatment and prevention is essential. Resection-anastomosis of the trachea is becoming the standard of care in many centers and gives the most consistent results in both adult and pediatric patients. But recurrence stenosis, re-granulation and re-inflammation are probable. This study aimed to assess the efficacy of systemic prednisolone on prevention of recurrent tracheal stenosis after surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Research Institute of Tuberculosis and Lung Disease, Iran
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion criteria:

1. Post-operative resection anastomosis patients.

2. Age more than 10 years old.

3. no severe tension in surgery by the opinion of surgeon.

Exclusion Criteria:

1. Pregnancy

2. History of significant medical condition not controlled by medicines. Ex:

cardiovascular diseases, endocrine impairments and etc.

3. Weight is ≥200% ideal body weight

4. Severe chronic liver disease

5. immunosuppression including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia

6. Fungal systemic infection