Trial Outcomes & Findings for Efficacy of Suction Enabled Retraction Device (NCT NCT03160170)

NCT ID: NCT03160170

Last Updated: 2019-05-15

Results Overview

Amount of blood loss from incision time to screw placement

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 1.5 hours
• Results posted on: 2019-05-15

Participant Flow

Participant milestones

Measure	Use of Cobb Device Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery	Control Standard exposure technique and instruments will be used during surgery
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Use of Cobb Device n=10 Participants Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery	Control n=10 Participants Standard exposure technique and instruments will be used during surgery	Total n=20 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 11.8 • n=10 Participants	71.1 years STANDARD_DEVIATION 7.4 • n=10 Participants	68.2 years STANDARD_DEVIATION 10.0 • n=20 Participants
Sex: Female, Male Female	2 Participants n=10 Participants	4 Participants n=10 Participants	6 Participants n=20 Participants
Sex: Female, Male Male	8 Participants n=10 Participants	6 Participants n=10 Participants	14 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1.5 hours

Amount of blood loss from incision time to screw placement

Outcome measures

Measure	Use of Cobb Device n=10 Participants Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery	Control n=10 Participants Standard exposure technique and instruments will be used during surgery
Estimated Blood Loss	364.0 ml Standard Deviation 363.1	356.0 ml Standard Deviation 256.5

SECONDARY outcome

Timeframe: 1.5 hours

Length of operation in minutes

Outcome measures

Measure	Use of Cobb Device n=10 Participants Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery	Control n=10 Participants Standard exposure technique and instruments will be used during surgery
Time of Exposure	38.2 minutes Standard Deviation 9.0	69.7 minutes Standard Deviation 56.1

SECONDARY outcome

Timeframe: 1.5 hours

Average number of times the suction tip of the device had to be unclogged

Outcome measures

Measure	Use of Cobb Device n=10 Participants Use of SISTER device during surgery SISTER device: Use of the Suction-Integrated Surgical Tissue Elevator \& Retractor (SISTER) device during surgery	Control n=10 Participants Standard exposure technique and instruments will be used during surgery
Rate of Clogging	10.1 tip clogs Standard Deviation 4.9	4.9 tip clogs Standard Deviation 6.0

Adverse Events

Use of Cobb Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ian Cote

University of Miami Miller School of Medicine

Phone: 305-256-4492

Email: Icote@med.miami.edu

Results disclosure agreements

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