A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas (Surgisis® AFP)

This study has been completed.
Sponsor:
Collaborators:
Cook Biotech Incorporated
Cook Ireland, Ltd.
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00545441
First received: October 16, 2007
Last updated: October 24, 2014
Last verified: June 2013
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anal Fistula
Interventions: Device: Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)
Device: Flap

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Surgisis® AFP Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
Flap Flap: Advancement flap surgery is performed; no anal fistula plug is placed

Participant Flow:   Overall Study
    Surgisis® AFP     Flap  
STARTED     43     39  
COMPLETED     26     26  
NOT COMPLETED     17     13  
Fistula draining at 6 months                 2                 4  
Lost to Follow-up                 9                 5  
Technical failure                 0                 1  
Withdrawal by Subject                 1                 1  
Persistence or recurrence of fistula                 5                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Surgisis® AFP Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
Flap Flap: Advancement flap surgery is performed; no anal fistula plug is placed
Total Total of all reporting groups

Baseline Measures
    Surgisis® AFP     Flap     Total  
Number of Participants  
[units: participants]
  43     39     82  
Age [1]
[units: years]
Mean ± Standard Deviation
  45.1  ± 13.2     49.4  ± 13.1     47.2  ± 13.3  
Gender  
[units: participants]
     
Female     10     16     26  
Male     33     23     56  
[1] One patient in the SurgiSIS AFP arm has age missing.



  Outcome Measures

1.  Primary:   Healing Success   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jason Hodde, Clinical Affairs Manager
Organization: Cook Biotech Incorporated
phone: 765-497-3355
e-mail: jhodde@cookbiotech.com


No publications provided


Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00545441     History of Changes
Other Study ID Numbers: 07-006
Study First Received: October 16, 2007
Results First Received: October 24, 2014
Last Updated: October 24, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices