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Adhesion Barrier

SprayShield Adhesion Barrier for Adenomatous Polyposis

N/A
Waitlist Available
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosis of ulcerative colitis or familial polyposis and require two-stage surgery for treatment of either of these disorders will be eligibl
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average 10-12 weeks post surgery

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.

Eligible Conditions
  • Colitis
  • Adenomatous Polyposis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average 10-12 weeks post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and average 10-12 weeks post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adhesion Involvement Along the Midline Incision (Percentage)
Mobilization Time
Severity of Adhesions

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SprayShield Adhesion BarrierExperimental Treatment1 Intervention
SprayShield Adhesion Barrier
Group II: ControlPlacebo Group1 Intervention
Good Surgical Technique Alone

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Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
108 Previous Clinical Trials
11,283 Total Patients Enrolled
~1 spots leftby Nov 2025
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