NCT04283916

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.3 years

First QC Date

February 21, 2020

Last Update Submit

January 31, 2024

Conditions

Open AbdomenBotulinum Toxin Injection

Outcome Measures

Primary Outcomes (1)

  • Abdominal wall closure

    Duration of open abdomen treatment

    30 days

Secondary Outcomes (6)

  • Intensive care time

    30 days

  • Hospitalization

    30 days

  • Hernia

    2 years

  • Re-laparotomies

    30 days

  • Enterocutaneus fistula

    30 days

  • +1 more secondary outcomes

Study Arms (1)

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.

Drug: Botulinum Toxins

Interventions

Botulinum ToxinsDRUG

Botulinum toxin injection to abdominal wall

Botox injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 consecutive open abdomen patients

You may qualify if:

  • Open abdomen

You may not qualify if:

  • Previous incisional hernia in midline
  • Patient is not in active treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Central Study Contacts

Elisa Mäkäräinen-Uhlbäck, M.D.

CONTACT

+358505794011elisa.makarainen-uhlback@ppshp.fi

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 25, 2020

Study Start

February 21, 2020

Primary Completion

June 1, 2024

Study Completion

August 1, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FI(1)