Open AbdomenNCT04283916
Botulinum Toxin Injection in the Treatment of Open Abdomen
An observational study of Open Abdomen and Botulinum Toxin Injection, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Abdomen, Botulinum Toxin Injection
- What is being tested?
- Botulinum Toxins
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 21 Feb 2020to Aug 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 consecutive open abdomen patients
Who may be able to join
- Open abdomen
Who cannot join
- Previous incisional hernia in midline
- Patient is not in active treatment
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu
Elisa Makarainen-Uhlback, +35883152282
About this study
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.
Read the 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.
- Conditions
- Open Abdomen, Botulinum Toxin Injection
- Being tested
- Botulinum Toxins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum ToxinsDrug
Botulinum toxin injection to abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Botulinum Toxins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall closure
Duration of open abdomen treatment
Measured: 30 days
Secondary outcomes (6)
Intensive care time
Treatment time in the intensive care unit
Measured: 30 days
Hospitalization
Time spent in the hospital
Measured: 30 days
Hernia
Incisional hernia incidence
Measured: 2 years
Re-laparotomies
Number of abdominal explorations
Measured: 30 days
Enterocutaneus fistula
Enterocutaneus fistula incidence
Measured: 30 days
Abdominal wall closure success rate
the rate of complite abdominal wall closure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start21 Feb 2020
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Mäkäräinen, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283916
- Sponsor's protocol ID
- 7/2020
- Status last verified
- Jan 2024
- First submitted
- 21 Feb 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Injection in the Treatment of Open Abdomen
- ClinicalTrials.gov ID
- NCT04283916
- Acronym / sponsor ID
- 7/2020
- Conditions
- Open Abdomen, Botulinum Toxin Injection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botox injection | – | Drug: Botulinum Toxins30 consecutive patients will have 300 IU of botulinum toxin injected to six spots in abdominal wall to gain abdominal wall musculature relaxation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 consecutive open abdomen patients
Key inclusion criteria (1 listed)
- Open abdomen
Key exclusion criteria (2 listed)
- Previous incisional hernia in midline
- Patient is not in active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum ToxinsBotulinum toxin injection to abdominal wall | Drug | Botox injection |
Primary outcome
Abdominal wall closure
Time frame: 30 days
Duration of open abdomen treatment
6 secondary outcomes
Intensive care time
Time frame: 30 days
Hospitalization
Time frame: 30 days
Hernia
Time frame: 2 years
Re-laparotomies
Time frame: 30 days
Enterocutaneus fistula
Time frame: 30 days
Abdominal wall closure success rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Abdomen and Botulinum Toxin Injection, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Mäkäräinen-Uhlbäck, M.D. (+358505794011, elisa.makarainen-uhlback@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal wall closure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.