Pilot Study Differential Dissector™ for Blunt Dissection

Not Applicable

Withdrawn

• Conditions: Blood Loss, Surgical; Surgical Adhesions
• Interventions: Other: Standard Dissection Method; Device: Differential Dissector

• Registration Number: NCT02382952
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The primary purpose of this study is to evaluate the quality of blunt dissection during abdominal and pelvic surgery involving dissection of adhesions, separation of blood vessels and neurovascular structures while preserving the integrity of these structures.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age greater than 18
• Patient will be undergoing open abdominal surgery
• Patient willing and able to provide his/her own consent

Exclusion Criteria

• Current alcohol or other substance abuse
• Current incarceration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dissection Method	Standard Dissection Method	For patients in the control group, blunt dissection will be performed by standard method.
Differential Dissector	Differential Dissector	For patients in the study device group, blunt dissection will be performed with the Differential Dissector whenever the surgeon believes its use is appropriate.

Primary Outcome Measures

Name	Time	Method
Post-operative Blood Loss	After surgical closure and drain insertion through drain removal
Operative Blood Loss	From start of surgery to wound closure