A comparative study of collagen based dressing versus normal saline dressing in chronic ulcers:A Randomized controlled trial.

This randomized controlled trial will be conducted in the Department of Surgery at the Regional Institute of Medical Sciences RIMS, Imphal, over a period of two years from August 2025 to August 2027. The study will focus on patients with chronic non-healing ulcers, recruiting a total of 72 participants 34 in each group who meet specific inclusion criteria such as having ulcers of size 1 to 25 cm2, being over 18 years of age, and willing to give informed consent. Ulcers of all etiologies except arterial will be included. Exclusion criteria comprise arterial ulcers, ulcers with exposed bone or tendons, malignancy, use of immunosuppressants or chemotherapy, and unwillingness to participate. Participants will be randomized into two groups using block randomization block size of 4, with sequence generation done by an external colleague via www.sealedenvelope.com. Allocation will be concealed using opaque sealed envelopes. Blinding will be maintained at both the patient and investigator levels. Group A will receive collagen granule dressings, while Group B will receive normal saline dressings. Both dressings will be administered by a surgeon not involved in the assessment to ensure blinding. Ulcers will be evaluated for key outcomes such as the appearance of healthy granulation tissue, time to 50% reduction in ulcer size, need for skin grafting, and total healing time. Measurements will be taken using sterile surgical tools including rulers and Vernier callipers on days 3, 5, 7, 10, 15, and 21. The data collected will be checked for accuracy and analysed using SPSS version 26.0. Categorical data will be assessed using the chi-square or Fisher’s exact test, while continuous data will be analysed with either the independent sample t-test or the Mann Whitney U test, with a significance level set at p less than 0.05. The study has sought ethical approval from the Research Ethics Board of RIMS, Imphal. Written informed consent will be obtained from all participants. Confidentiality will be maintained through coded data, which will be securely stored with access limited to the investigator and authorized personnel. This study aims to determine the comparative effectiveness of collagen granules versus normal saline in promoting healing in chronic ulcers.