Treatment of Post-Op Wound Infection

Condition: Extremity Fractures / Postoperative Wound Infections

Eligibility

Key Inclusion Criteria

  • Any fractures of any bone at or proximal to and including the tarsal/metatarsal joint or proximal to the carpal joints, excluding the spine, treated with any type of internal fixation
  • Undergoing fusion of any bone at or proximal to and including the subtalar joint or radial carpal joint (excluding the spine), that develops a postoperative wound infection
  • Patients diagnosed with a wound infection of the study injury

Key Exclusion Criteria

  • High risk of amputation of the study limb
  • Undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation
  • History of chronic infection at the site of study injury

Full Study Name

A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-Op Wound Infection After Extremity Fractures (POvIV Study) (IRB no. 45858)

Summary

This study focuses on patients who have a long bone fracture and an infection in their wound. The purpose of the study is to determine the best treatment for such infections. Infections after surgery are usually treated with antibiotics. The standard treatment uses intravenous (liquid) antibiotic medicine, but in some places, oral antibiotics (pills) are used. The standard method of delivery (how the antibiotics are received) is determined by the individual physician. Researchers will compare the effectiveness of oral antibiotic pills to the standard treatment, antibiotic liquid given through an IV, to determine which is more effective. The study will also compare the costs of these two treatments.

Phase
Phase III


Principal Investigator

Charles Moon, MD

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