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A Trial to Assess the Effect and Safety of the C-Qur™ Film

NCT01872650 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-12-05

No results posted yet for this study

Summary

Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading to serious consequences and complications at reoperation.

The investigators initiate a prospective, randomized, controlled, multicenter trial to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.

Conditions

  • Postoperative Adhesions

Interventions

DEVICE

C-Qur

In subjects assigned to the treatment arm, the C-Qur™ Film must be applied beneath the incision. The C-Qur™ film can also be applied to other areas considered to be adhesiogenic (e.g. the dissection site and ostomy site but not around the anastomosis). The number of C-Qur™ Film sheets placed is limited to a maximum area of coverage of 774cm2.

Sponsors & Collaborators

  • University Medical Center Nijmegen

    lead OTHER

Principal Investigators

  • Harry van Goor, MD, PhD · Department of Surgery, Radboud University Nijmegen Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01872650 on ClinicalTrials.gov