Clinical Research Directory

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2

The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers. The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol. Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible. In the definitive wound closure/coverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages

The study aimed to assess the efficacy of customized pressure-guided elastic bandages (CPG-EB) in preventing postoperative edema and complications in Coronary Artery Bypass Graft (CABG) patients. While compression therapy, like compressive stockings, has benefits in preventing edema, concerns about affordability persist. CPG-EB provides optimal sub-bandage pressure, proven effective in venous leg ulcers. Implementing CPG-EB post-CABG could enhance venous blood flow, reducing complications and improving outcomes. Patients were divided into two groups: one with CPG-EB and the other standard post-CABG care. Data collected at 1, 2, and 6 weeks post-surgery assessed swelling and wound complications. Comparative analysis used standardized criteria.