A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

Post Operative Wound Infection Clinical Trial

Official title: A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics

Status Terminated

Clinical Trial Summary

This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects undergoing abdominal surgery.

Clinical Trial Description

Post-surgical site infections account for approximately 20% of total healthcare-associated infections (HAI), making surgical site infections the most common HAI in US hospitals. Despite the routine use of prophylactic systemic antibiotics and improvements in surgical techniques, surgical site infections continue to be associated with significant morbidity, reduction in quality of life and overall cost following abdominal surgery.

Ruthigen is conducting this Phase I/II clinical study to evaluate the safety and potential efficacy of RUT058-60 in preventing surgical deep incisional and organ space infection in subjects undergoing abdominal surgery as an adjunctive therapy to prophylactic systemic antibiotics. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Post Operative Wound Infection
• Postoperative Wound Infection-deep
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

• NCT number: NCT02280395
• Study type: Interventional
• Source: Pulmatrix Inc.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 2014
• Completion date: June 2015