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

NCT02855502 | Completed Phase 4 DMC

• 1 other identifier: F93162
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheal Stenosis

Outcome Measures

Primary Outcomes (1)

• Completely wound healing.

  achieved by fiber optic bronchoscopy (FOB) and a surgeon judged that the patients were with out any sign of clinical symptoms of upper respiratory tract stenosis postoperatively and anastomosis site was with out any presence of stenosis (fibrous tissue), granulation tissue formation and inflamed mucosa.

  30 days

Secondary Outcomes (1)

• Granulation tissue formation without visible dehiscence

  30 days

Other Outcomes (2)

• inflammation

  30 days

• Partial and complete dehiscence with or without infection

  30 days

Study Arms (2)

Prednisolone

ACTIVE COMPARATOR

dose: 15 mg per day(divided 5 mg TDS) dosage form: tablet duration administration: 30 days

Drug: Prednisolone

Placebo

PLACEBO COMPARATOR

placebo given to patient: 3 tablet (divided TDS) dosage form: tablet duration administration: 30 days

Drug: Placebo

Interventions

Prednisolone DRUG

Prednisolone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-operative resection anastomosis patients.
• Age more than 10 years old.
• no severe tension in surgery by the opinion of surgeon.

You may not qualify if:

• Pregnancy
• History of significant medical condition not controlled by medicines. Ex: cardiovascular diseases, endocrine impairments and etc.
• Weight is ≥200% ideal body weight
• Severe chronic liver disease
• immunosuppression including HIV+ status, history of bone marrow or solid organ transplantation, current malignancy, neutropenia
• Fungal systemic infection

Sponsors & Collaborators

• National Research Institute of Tuberculosis and Lung Disease, Iran: lead

Study Sites (1)

Unknown Facility

Tehran, Iran

Location

MeSH Terms

Conditions

Tracheal Stenosis

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Tracheal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: August 4, 2016
• Study Start: November 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)