Back to resultsAn Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Primary Purpose
Ulcerative Colitis, Familial Polyposis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SprayShield Adhesion Barrier System
Good Surgical Technique Alone
Sponsored by
About this trial
This is an interventional prevention trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
Sites / Locations
- Covidien
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
SprayShield Adhesion Barrier
Control
Arm Description
SprayShield Adhesion Barrier
Good Surgical Technique Alone
Outcomes
Primary Outcome Measures
The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
Secondary Outcome Measures
Severity of Adhesions
Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".
Adhesion Involvement Along the Midline Incision (Percentage)
The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.
Mobilization Time
The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
Full Information
NCT ID
NCT01002287
First Posted
October 26, 2009
Last Updated
November 7, 2014
Sponsor
Integra LifeSciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01002287
Brief Title
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
Official Title
An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated for business purposes, not for safety or efficacy reasons.
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a prospective, multi-center, randomized, single blind study to collect and evaluate post-market clinical data on the SprayShield Adhesion Barrier System as an adjuvant to good surgical technique for the reduction of postoperative adhesion formation following major open abdominal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Familial Polyposis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SprayShield Adhesion Barrier
Arm Type
Experimental
Arm Description
SprayShield Adhesion Barrier
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Good Surgical Technique Alone
Intervention Type
Device
Intervention Name(s)
SprayShield Adhesion Barrier System
Intervention Description
Adhesion Barrier Device
Intervention Type
Procedure
Intervention Name(s)
Good Surgical Technique Alone
Intervention Description
Good Surgical Technique Alone
Primary Outcome Measure Information:
Title
The Incidence of Adhesions, Defined as the Proportion of Subjects Presenting at the Follow-up Surgery (10-12 Weeks) With One or More Adhesions to the Midline Incision, Regardless of Extent and/or Severity.
Time Frame
10-12 Weeks post Initial Surgery for J-Pouch
Secondary Outcome Measure Information:
Title
Severity of Adhesions
Description
Worst midline adhesion severity score. The severity of adhesions was categorized as filmy thickness, avascular; moderate thickness, limited vascularity; and dense thickness, vascularised. The corresponding numeric severity ratings are "1", "2", and "3". Subjects without adhesions were assigned a severity rating of "0".
Time Frame
Average 10-12 weeks post surgery
Title
Adhesion Involvement Along the Midline Incision (Percentage)
Description
The proportion of the total length of the initial midline incision associated with any adhesion at the time of the follow-up surgery, as determined by dividing the length of the incision associated with adhesions (cm) by the overall initial midline incision length (cm). This calculates the extent of adhesion involvement as a percentage.
Time Frame
average 10-12 weeks post surgery
Title
Mobilization Time
Description
The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.
Time Frame
average 10-12 weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible
Facility Information:
Facility Name
Covidien
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery
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