HealthyNCT00385892
Safety Study of Textile Binder for Abdominal Compression
A study testing Abdominal binder in people with Healthy, run by Coloplast A/S.
Trial summary
This safety study was carried out to investigate to what extent the use of an abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Abdominal binder
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Oct 2005
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 18 years old
- Healthy
- Negative test of blood, nitrate or leucocytes in urinre
- Waist line measurement 97-110 cm
Who cannot join
- Pregnant
- Known allergy
- Know bladder disease
- Tendency of/clinicla symptoms of urinay infection
- Abdominal or urinary surgery
- Medical treatment
About this study
Official title: Feasibility Study DK150OS. Testing of Compression Textile. A Safety Study Among Healthy Volonteers
This safety study was carried out to investigate to what extent the use of an abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure.
Read the detailed description
Study Description: Transabdominal surgery might be associated with incisional pain, fear of rupture, inhibited mobilisation and risk of incisional herniation. An abdominal binder was developed for postoperative support of abdominal incisions. The abdominal binder provides a pressure of 10-15 mmHg.
Worlds Society on Abdominal Compartment Syndrome (WSACS) defines that Normal Intra-Abdominal Pressure (IAP) is approximately 5-7 mmHg in critically ill adults, and that Intra-Abdominal Hypertension (IAH) is a sustained or repeated pathologic elevation of IAP >12 mmHg. This safety study was carried out to investigate to what extent the use of the abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure (Foley manometer, Holtec Medical, Copenhagen) in 11 healthy volunteers with and without wearing the abdominal binder.
Results IAP measurements without wearing the abdominal binder were found to be surprisingly high with a range between 8,0 and 16,7 mmHg. (mean 10,5 mmHg.). This finding is explained by the fact that the subjects were not under relaxation and the fact that half of the subjects according to their BMI were categorised as being overweight or fat. Other investigations have demonstrated that relaxation decreases IAP and that BMI is positively related to IAP.
We found that wearing the abdominal binder did increase IAP with a mean of 4,0 mmHg. (+/-1,4) or 39,3% (+/-14,61%).
In conclusion Relating our results to the WSACS guidelines regarding IAP and IAH it is not likely that the use of the abdominal binder will increase IAP to a clinically critical extent in patients with normal IAP. It must though be assessed from case to case, whether the use of the abdominal binder is appropriate.
- Conditions
- Healthy
- Being tested
- Abdominal binder
- Keywords
- Healthy volonteers, Abdominal binder, IAP, MAP, APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal binderDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Abdominal Pressure (IAP)
Mean Arterial Pressure (MAP)
Abdominal Perfussion Pressure (APP)
Secondary outcomes (2)
Comfort
Freedom of movement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startAug 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lone M Poulsen, Consultant, Principal investigator, ITA 303 KAS-Gentofte Niels Andersensvej 65 2900 Hellerup DENMARK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385892
- Sponsor's protocol ID
- DK150OS
- Status last verified
- Oct 2006
- First submitted
- 9 Oct 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study DK150OS. Testing of Compression Textile. A Safety Study Among Healthy Volonteers
- ClinicalTrials.gov ID
- NCT00385892
- Acronym / sponsor ID
- DK150OS
- Conditions
- Healthy
- Keywords
- Healthy volonteers, Abdominal binder, IAP, MAP, APP
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Oct 2005
- First posted
- 11 Oct 2006 (estimated)
- 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.
This safety study was carried out to investigate to what extent the use of an abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure.
Detailed description
Study Description: Transabdominal surgery might be associated with incisional pain, fear of rupture, inhibited mobilisation and risk of incisional herniation. An abdominal binder was developed for postoperative support of abdominal incisions. The abdominal binder provides a pressure of 10-15 mmHg.
Worlds Society on Abdominal Compartment Syndrome (WSACS) defines that Normal Intra-Abdominal Pressure (IAP) is approximately 5-7 mmHg in critically ill adults, and that Intra-Abdominal Hypertension (IAH) is a sustained or repeated pathologic elevation of IAP >12 mmHg. This safety study was carried out to investigate to what extent the use of the abdominal binder influences IAP. The study was designed as a comparative cross-over study measuring bladder pressure (Foley manometer, Holtec Medical, Copenhagen) in 11 healthy volunteers with and without wearing the abdominal binder.
Results IAP measurements without wearing the abdominal binder were found to be surprisingly high with a range between 8,0 and 16,7 mmHg. (mean 10,5 mmHg.). This finding is explained by the fact that the subjects were not under relaxation and the fact that half of the subjects according to their BMI were categorised as being overweight or fat. Other investigations have demonstrated that relaxation decreases IAP and that BMI is positively related to IAP.
We found that wearing the abdominal binder did increase IAP with a mean of 4,0 mmHg. (+/-1,4) or 39,3% (+/-14,61%).
In conclusion Relating our results to the WSACS guidelines regarding IAP and IAH it is not likely that the use of the abdominal binder will increase IAP to a clinically critical extent in patients with normal IAP. It must though be assessed from case to case, whether the use of the abdominal binder is appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum 18 years old
- Healthy
- Negative test of blood, nitrate or leucocytes in urinre
- Waist line measurement 97-110 cm
Key exclusion criteria (6 listed)
- Pregnant
- Known allergy
- Know bladder disease
- Tendency of/clinicla symptoms of urinay infection
- Abdominal or urinary surgery
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 |
|---|---|---|
| Abdominal binder | Device | – |
Primary outcome
Intra Abdominal Pressure (IAP)
Mean Arterial Pressure (MAP)
Abdominal Perfussion Pressure (APP)
2 secondary outcomes
Comfort
Freedom of movement
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
Lone M Poulsen, Consultant principal investigator
ITA 303 KAS-Gentofte Niels Andersensvej 65 2900 Hellerup DENMARK
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal binder in people with Healthy, run by Coloplast A/S.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra Abdominal Pressure (IAP). The study lists 3 primary outcomes in all. 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 11 Oct 2006.