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Botulinum Toxin Injection in the Treatment of Open Abdomen

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ClinicalTrials.gov Identifier: NCT04283916
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Elisa Makarainen-Uhlback, University of Oulu

Tracking Information
First Submitted Date February 21, 2020
First Posted Date February 25, 2020
Last Update Posted Date February 26, 2020
Actual Study Start Date February 21, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 24, 2020)
Abdominal wall closure [ Time Frame: 30 days ]
Duration of open abdomen treatment
Original Primary Outcome Measures
 (submitted: February 21, 2020)
Abdominal wall closure [ Time Frame: 30 days ]
Time from the start of open abdomen to abdominal wall closure
Change History
Current Secondary Outcome Measures
 (submitted: February 21, 2020)
  • Intensive care time [ Time Frame: 30 days ]
    Treatment time in the intensive care unit
  • Hospitalization [ Time Frame: 30 days ]
    Time spent in the hospital
  • Hernia [ Time Frame: 2 years ]
    Incisional hernia incidence
  • Re-laparotomies [ Time Frame: 30 days ]
    Number of abdominal explorations
  • Enterocutaneus fistula [ Time Frame: 30 days ]
    Enterocutaneus fistula incidence
  • Abdominal wall closure success rate [ Time Frame: 30 days ]
    the rate of complite abdominal wall closure
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Botulinum Toxin Injection in the Treatment of Open Abdomen
Official Title Botulinum Toxin Injection in the Treatment of Open Abdomen
Brief Summary Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.
Detailed Description 30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 30 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 30 consecutive open abdomen patients
Condition
  • Open Abdomen
  • Botulinum Toxin Injection
Intervention Drug: Botulinum Toxins
Botulinum toxin injection to abdominal wall
Study Groups/Cohorts Botox injection
30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation.
Intervention: Drug: Botulinum Toxins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 21, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Open abdomen

Exclusion Criteria:

  • Previous incisional hernia in midline
  • Patient is not in active treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Elisa Mäkäräinen-Uhlbäck, M.D. +358505794011 elisa.makarainen-uhlback@ppshp.fi
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04283916
Other Study ID Numbers 7/2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Elisa Makarainen-Uhlback, University of Oulu
Study Sponsor University of Oulu
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Oulu
Verification Date February 2020