Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
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|ClinicalTrials.gov Identifier: NCT03374189|
Recruitment Status : Completed
First Posted : December 15, 2017
Results First Posted : February 4, 2019
Last Update Posted : March 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Port Site Hernia||Device: EZ close Device: Carter Thomason||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device|
|Actual Study Start Date :||August 17, 2017|
|Actual Primary Completion Date :||May 9, 2018|
|Actual Study Completion Date :||May 24, 2018|
Experimental: EZ Close arm
EZ close used for port-site closure.
Device: EZ close
EZ close used.
Active Comparator: Carter Thomason arm
Carter Thomason used for port-site closure.
Device: Carter Thomason
Carter Thomason used.
- Time Taken to Complete Closure [ Time Frame: At the time of surgery ]The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.
- Number of Participants With Visceral Organ Injury [ Time Frame: At the time of surgery ]Any inadvertent injury to organs or bleeding during procedure.
- Number of Participants With Need for Additional Instrument [ Time Frame: At the time of surgery ]Need for additional instrument during procedure
- Number of Participants With Port-site Hernia [ Time Frame: 3 days post-op and within one months of surgery ]Herniation of bowel segments through port-site
- Number of Participants With Port-site Infection [ Time Frame: 3 days post-op and within one months of surgery ]Redness, purulent discharge, tenderness at port-site
- Number of Participants With Ascitic Fluid Leakage [ Time Frame: 3 days post-op and within one months of surgery ]Non-infective fluid leakage
- Number of Participants With Wound Dehiscence [ Time Frame: 3 days post-op and within one months of surgery ]Wound dehiscence that required further treatment
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): NCT03374189
|Korea, Republic of|
|St. Vincent's Hospital|
|Suwon, Korea, Republic of, 16247|
|Principal Investigator:||Hee Youn Kim||St. Vincent's Hospital-Manhattan|