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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by University Medical Center Nijmegen
Sponsor:
Information provided by (Responsible Party):
Drs. M.W.J. Stommel, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01872650
First received: June 4, 2013
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Postoperative Adhesions
Device: C-Qur

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Clinical Trial to Assess the Effect and Safety of the C-Qur™ fiLm, an antI-adhesive Barrier for the PrevEntion of sUrgical adhesionS

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • adhesions at the incision site [ Time Frame: 8-16 weeks after index surgery ] [ Designated as safety issue: No ]
    The incidence of adhesions at the incision site


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No placement of an adhesion barrier
Experimental: C-Qur
C-Qur film placement beneath the incision. Possibly placement of C-Qur film at other sites considered to be adhesiogenic (but not around the anastomosis)
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing either open or hand assisted laparoscopic colonic and/or rectal resection whereby an incision is made of 6 cm or longer
  • Patients willing and capable of providing written informed consent prior to study enrolment

Exclusion Criteria:

  • Pregnant women
  • Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure between 8 and 16 weeks is not feasible for any reason
  • Patients with known/active intra-abdominal infection such as peritonitis, abdominal abscess, anastomotic leakage or fistula (Interloop abscesses in the resection specimen is not an exclusion criterion)
  • Patients with endometriosis
  • Patients with known allergies to any component of the C-Qur Film device
  • Patients requiring an additional procedure at the time of loop ileostomy or colostomy takedown deemed interfering with adhesion assessment by the treating surgeon.
  • Patients in whom it is intended to use intraoperative lavage/irrigation with any anti-adhesion solutions other than lactated ringers and/or saline (e.g. dextran, heparin, corticosteroids, ADEPT, any other irrigant that is believed to have anti-adhesion properties ) or an adhesion barrier other than C-Qur Film™.
  • Patients who have received within the last 30 days or are planned to receive systemic agents prior to the index procedure with the intention to prevent adhesion formation
  • Planned chemotherapy and/or abdominal radiotherapy between index surgery and loop ileostomy or colostomy takedown
  • Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing (patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded). Patients requiring perioperative corticosteroid supplementation are not to be excluded.
  • Patients with impaired immune system function or coagulation disorders deemed by the surgeon to interfere with wound healing
  • Patients with a known history of severe multiple drug allergies
  • Patients who have a life expectancy of less than 6 months because of a medical condition or disease state
  • Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrolment
  • Patients participating in a study of another investigational device or drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872650

Contacts
Contact: Martijn Stommel, MD 0031-24-3617365 m.stommel@chir.umcn.nl
Contact: Chema Strik, MD 0031-24-3610905 c.strik@chir.ucmn.nl

Locations
Netherlands
Department of Surgery, Radboud University Nijmegen Medical Center
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
University Medical Center Nijmegen
Investigators
Study Chair: Harry van Goor, MD, PhD Department of Surgery, Radboud University Nijmegen Medical Center
  More Information

No publications provided by University Medical Center Nijmegen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drs. M.W.J. Stommel, MD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01872650     History of Changes
Other Study ID Numbers: CLIPEUS
Study First Received: June 4, 2013
Last Updated: June 6, 2013
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by University Medical Center Nijmegen:
postoperative adhesions
adhesion prevention
colorectal surgery
temporary ostomy

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014