Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial.

Abstract

Peri-trochanteric fractures, common among the elderly with osteoporosis, pose significant morbidity and mortality risks. These fractures are increasing due to the ageing population, with Nordic countries seeing a high incidence. They present challenges for orthopaedic surgeons and can lead to functional decline and high medical costs. Hip fractures have severe consequences, including pain, immobility and increased mortality. Managing wound care is complex, involving various healing phases. Trehalose, a disaccharide with antioxidant and anti-inflammatory properties, has shown promise in wound healing and other health conditions. Studies suggest its potential benefits in reducing inflammation and aiding wound healing in peri-trochanteric fracture patients, but more research is needed to confirm its clinical effectiveness in humans. The study is a double-blind, placebo-controlled randomised clinical trial aiming to evaluate the effect of trehalose consumption on patients with peri-trochanteric fractures. The study will include 64 patients meeting specific inclusion criteria and will assess inflammatory markers and wound healing at different time points. Patients will be divided into two groups, one receiving trehalose and the other receiving a placebo for 12 weeks. Various measurements and assessments will be conducted, including biochemical assays, wound assessments, anthropometric measurements and dietary intake evaluations. Data analysis will be performed using SPSS software, and statistical tests will be used to compare outcomes between the intervention and control groups. The Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.RETECH.REC.1403.191). Iranian Registry of Clinical Trials. IRCT20180404039188N5. URL of trial registry record: https://irct.behdasht.gov.ir/trial/77572. Registration date: 7 July 2024.