Trial Outcomes & Findings for Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone (NCT NCT01044589)

NCT ID: NCT01044589

Last Updated: 2017-08-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2017-08-01

Participant Flow

Participant milestones

Measure	Overlapping Sphincter Repair Control Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone
Overall Study STARTED	6	7
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

Baseline characteristics by cohort

Measure	Overlapping Sphincter Repair n=6 Participants Control Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Biodesign Tissue Repair Graft n=7 Participants Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Overlapping Sphincter Repair n=3 Participants Control Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Biodesign Tissue Repair Graft n=3 Participants Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	Overlapping Sphincter Repair n=5 Participants Control Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Biodesign Tissue Repair Graft n=3 Participants Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone
Number of Participants Reporting a Decrease in Incontinence Episodes Per Week	1 Participants	1 Participants

Adverse Events

Overlapping Sphincter Repair

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biodesign Tissue Repair Graft

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Overlapping Sphincter Repair n=6 participants at risk Control Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone	Biodesign Tissue Repair Graft n=7 participants at risk Biodesign Tissue Repair Graft Biodesign Tissue Repair Graft: Biodesign Tissue Repair Graft reinforcement Overlapping Sphincter Repair: Overlapping Sphincter Repair Alone
Cardiac disorders Myocardial Infarction	0.00% 0/6 • 2 Years	14.3% 1/7 • Number of events 1 • 2 Years

Other adverse events

Adverse event data not reported

Additional Information

Dr. Massarat Zutshi

Cleveland Clinic

Phone: (216) 444-3540

Email: zutshim@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place