Pilot Study Differential Dissector™ for Blunt Dissection

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02382952

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Adhesions Blood Loss, Surgical	Device: Differential Dissector Other: Standard Dissection Method	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Pilot Study Differential Dissector™ for Blunt Dissection

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Differential Dissector
Active Comparator: Standard Dissection Method For patients in the control group, blunt dissection will be performed by standard method.	Other: Standard Dissection Method

Arm

Intervention/Treatment

Experimental: 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.

Device: Differential Dissector

Active Comparator: Standard Dissection Method

For patients in the control group, blunt dissection will be performed by standard method.

Other: Standard Dissection Method

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Investigators

Principal Investigator: Mark Koruda, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of North Carolina, Chapel Hill

ClinicalTrials.gov Identifier:

NCT02382952

Other Study ID Numbers:

14-2888

First Posted:

Mar 9, 2015

Last Update Posted:

Aug 5, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University of North Carolina, Chapel Hill

Lysis of abdominal adhesions

Additional relevant MeSH terms:

Tissue Adhesions

Blood Loss, Surgical

Study Results

No Results Posted as of Aug 5, 2016