Clinical Research Directory

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation

This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.

Vacuum-assisted Closure Versus Conventional Dressings in Infected Lower-limb Wounds

Wound healing is a complex and dynamic process that includes an immediate sequence of cell migration leading to repair and closure. Delayed wound healing or non-healing of ulcers is a significant health problem, particularly in older adults. Vacuum assisted closure (VAC) is a relatively new technology with applications in a variety of difficult to manage acute and chronic wounds. Literature showed that the outcomes of VAC is a better than other method. Therefore, this study has been planned. This Randomized controlled trial will be done at Department of General Surgery, Dr Faisal Masood Teaching Hospital, Sargodha for 12 months.Sample size of 90 cases; 45 in each groups will be included through Non-probability consecutive sampling and will be randomly divided into 2 equal groups. In group A, VAC will be applied to wound. In group B, conventional dressing will be applied on wound. Wound size after one week will be assessed. If wound will heal completely, then duration for complete healing will be noted. Success will also be noted. All the data will be recorded in proforma.All the data will be analyzed with SPSS version 25. Both groups will be compared by using independent samples t-test for duration of healing, and wound size after a week and chi-square test for success. P-value ≤ 0.05 will be considered as significant. Conclusion and recommendations will be made to obtain better results with high success rate, which will lead to better quality of life and early discharge of patients.

Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures

This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization.

Compare Wound Sampling Methods Efficacy in Microbiology Culture

Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.