A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02280395|
Recruitment Status : Terminated (Company merger resulted in business decision to terminate the study.)
First Posted : October 31, 2014
Last Update Posted : August 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Wound Infection-deep Post Operative Wound Infection||Drug: RUT058-60 Drug: Sterile saline for irrigation||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.
|Placebo Comparator: Sterile Saline for Irrigation||
Drug: Sterile saline for irrigation
Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.
- Safety and tolerability will be determined by nature and incidence of adverse events and clinical laboratory values compared to saline control group. Wound site physical inspection tabulated result compared to saline control group. [ Time Frame: 28 Days ]
- Potential efficacy will be determined by the proportion of subjects who do not develop a surgical deep incisional or organ/space infection by Day 28 post-application compared to the saline control group. [ Time Frame: 28 Days ]In each of the two groups, the proportion of subjects who are deep incisional and organ/space infection-free will be estimated, along with a two-sided, 90% exact binomial confidence interval for the true rate in each group.
- Exploratory Analysis- Overall length of hospital stay [ Time Frame: 28 Days ]
- Exploratory Analysis- Readmission to the hospital within the first 28-days post-operative procedure [ Time Frame: 28 Days ]
- Exploratory Analysis- Incisional wound healing time frame [ Time Frame: 28 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280395
|United States, Alabama|
|University of South Alabama Medical Center|
|Mobile, Alabama, United States, 36695|
|United States, California|
|University of California, San Diego, Thornton Hospital|
|La Jolla, California, United States, 92037|
|United States, Texas|
|BJJS, Corp., Memorial Hermann Memorial Medical Center|
|Houston, Texas, United States, 77024|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22904|
|Principal Investigator:||Traci Hedrick, MD||University of Virginia|
|Principal Investigator:||Timothy I Melson, MD||Shoals Medical Trials, Helen Kellar Hospital|
|Principal Investigator:||Harold Minkowitz, MD||BJJS Corporation, Memorial Hermann Memorial Medical Center|
|Principal Investigator:||Paul Rider, MD||University of South Alabama Medical Center|
|Principal Investigator:||Sonia Ramamoorthy, MD||University of California, San Diego|
|Principal Investigator:||AnaMaria Garza, MD||PVMDI, Glendale Memorial (Dignity Health)|