A COMPARATIVE STUDY ON THE EFFECT OF TOPICAL MITOMYCIN C AND NORMAL SALINE ON GRANULATION TISSUE IN TRACHEOSTOMISED PATIENTS

Abstract

BACKGROUND Tracheostomy is a surgical procedure performed to secure airway which can be in emergency or in elective setting. Granulation tissue is a late complication of tracheostomy which may cause airway occlusion, haemorrhage, difficulty in changing the tracheostomy tube, delayed decannulation, obstruction of tracheostomy tube, and can induce tracheal stenosis. Stomal granulation tissue can form at various sites like peristomal area, within the trachea, in the trachea at the distal end of the tube. The incidence of stomal granulation in tracheostomised patients ranges from 10%-80%. Ideal treatment for granulation tissue is not yet known but, various treatment modalities have been used to control and treat granulation tissue which includes topical application of corticosteroid creams, antibiotic preparations, silver nitrate, polyurethane foam dressings. Surgical interventions may at time be needed when granulation tissue becomes obstructive which includes laser ablation, electro cautery, resection, which may not be available in all centres. Mitomycin C (MMC) has been used in other airway surgeries to reduce stenosis and to reduce formation of granulation tissues as it is known to reduce fibroblast proliferation which is a key component of granulation tissue. In this study we intend to find the efficacy of topical MMC in preventing or minimizing granulation tissues in tracheostomised patients. OBJECTIVES: 1. To study the effect of Mitomycin C on granulation tissue in tracheostomised patients 2. To study the effect of Normal saline on granulation in tracheostomised patients xvii 3. To compare the dimensions of granulation tissue formed in tracheostomised patients administered Mitomycin C with a placebo group. METHODS:  This comparative study was done on 68 patients satisfying the inclusion criteria who underwent tracheostomy in our institution during the study period July 2022 to May 2024. Patients were randomly allocated by block randomization into two groups, each with 34 patients. The study group was Group A- MMC and placebo group was Group B-NS.  The patients in Group A (MMC) and Group B(NS)were subjected to three topical applications of 1 ml of MMC (0.4mg/ml) and 1 ml of normal saline respectively for 2 minutes intra-operatively during tracheostomy and repeated again on post-operative day 5 and day7. The patients were followed up every week to see for the presence of granulation tissue in and around the tracheostoma.  Using vernier callipers the length and thickness of granulation tissue were measured 2nd week, 4th week, and 6th week post tracheostomy and was documented and outcomes compared. RESULTS: The mean age of patients in Group A was 54.5±13.3 years and in Group B was 57.26±12.4 years with majority of the patients were males (Group A-70.6%, Group B- 76.5%). The overall incidence of granulations in Group A(MMC) was 35.3% compared to 82.4% in Group B (NS) and was statistically significant (p value <0.001). Delayed xviii onset of granulation tissue was observed in our study in Group A (end of second week) compared to group B (end of first week). At six weeks follow up Group A exhibited higher number of Grade II (14.71%) stomal granulation compared to Grade IV (14.71%) in Group B. When compared to the normal saline-treated group, (Grade I -14.71% Grade III – 11.76% and Grade IV - 14.71%) the Mitomycin treated group had minimal peristomal granulation, (Grade II, 5.88%) with P value of 0.003. Also Group B (NS) exhibited a higher incidence of Grade IV granulation) compared to Group A. When compared to placebo group (19 patients,55.8%) there was less incidence of stomal stenosis in patients treated with mitomycin C (6 patients,17.64%) and was statistically significant (p value 0.001) CONCLUSION: MMC does not completely arrest the development of granulations but leads to delay in the onset and progression of granulation and thereby reduces the risk of stomal stenosis.