An Evaluation of SprayShield in Reducing Post-Operative Adhesion Formation Following Major Open Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002287
Recruitment Status : Terminated (Study was terminated for business purposes, not for safety or efficacy reasons.)
First Posted : October 27, 2009
Results First Posted : January 29, 2014
Last Update Posted : November 20, 2014
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Familial Polyposis Device: SprayShield Adhesion Barrier System Procedure: Good Surgical Technique Alone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: An Evaluation of the SprayShield Adhesion Barrier System in Reducing Post-Operative Adhesion in Abdominal Surgery
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: SprayShield Adhesion Barrier
SprayShield Adhesion Barrier
Device: SprayShield Adhesion Barrier System
Adhesion Barrier Device

Sham Comparator: Control
Good Surgical Technique Alone
Procedure: Good Surgical Technique Alone
Good Surgical Technique Alone

Primary Outcome Measures :
  1. 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 Measures :
  1. Severity of Adhesions [ Time Frame: Average 10-12 weeks post surgery ]
    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".

  2. Adhesion Involvement Along the Midline Incision (Percentage) [ Time Frame: average 10-12 weeks post surgery ]
    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.

  3. Mobilization Time [ Time Frame: average 10-12 weeks post surgery ]
    The time (minute) required to incise and mobilize the ileal loop in preparation for reanastomosis for ileostomy closure.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligible

Information from the National Library of Medicine

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 identifier (NCT number): NCT01002287

United States, Massachusetts
Bedford, Massachusetts, United States, 01710
Sponsors and Collaborators
Integra LifeSciences Corporation

Responsible Party: Integra LifeSciences Corporation Identifier: NCT01002287     History of Changes
Other Study ID Numbers: ABD-08-001
First Posted: October 27, 2009    Key Record Dates
Results First Posted: January 29, 2014
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Colitis, Ulcerative
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn