Botulinum Toxin Injection in the Treatment of Open Abdomen

NCT ID: NCT04283916

Last Updated: 2024-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-21

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Open Abdomen Botulinum Toxin Injection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Botulinum Toxins

Intervention Type DRUG

Botulinum toxin injection to abdominal wall

Interventions

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Botulinum Toxins

Botulinum toxin injection to abdominal wall

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Open abdomen

Exclusion Criteria

* Previous incisional hernia in midline
* Patient is not in active treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Elisa Mäkäräinen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu University Hospital

Oulu, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Elisa Mäkäräinen-Uhlbäck, M.D.

Role: CONTACT

+358505794011

Facility Contacts

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Elisa Makarainen-Uhlback

Role: primary

+35883152282

Other Identifiers

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7/2020

Identifier Type: -

Identifier Source: org_study_id

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