Safety Study of Textile Binder for Abdominal Compression
NCT ID: NCT00385892
Last Updated: 2006-10-11
Study Results
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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TERMINATED
NA
11 participants
INTERVENTIONAL
2005-08-31
2005-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Abdominal binder
Eligibility Criteria
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Inclusion Criteria
* Healthy
* Negative test of blood, nitrate or leucocytes in urinre
* Waist line measurement 97-110 cm
Exclusion Criteria
* Known allergy
* Know bladder disease
* Tendency of/clinicla symptoms of urinay infection
* Abdominal or urinary surgery
* Medical treatment
18 Years
ALL
Yes
Sponsors
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Coloplast A/S
INDUSTRY
Principal Investigators
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Lone M Poulsen, Consultant
Role: PRINCIPAL_INVESTIGATOR
ITA 303 KAS-Gentofte Niels Andersensvej 65 2900 Hellerup DENMARK
Other Identifiers
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DK150OS
Identifier Type: -
Identifier Source: org_study_id