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Safety Study of Textile Binder for Abdominal Compression

Feasibility Study DK150OS. Testing of Compression Textile. A Safety Study Among Healthy Volonteers

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00385892
Enrollment
11
Registered
2006-10-11
Start date
2005-08-31
Completion date
2005-10-31
Last updated
2006-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volonteers, Abdominal binder, IAP, MAP, APP

Brief 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.

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.

Interventions

Sponsors

Coloplast A/S
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Minimum 18 years old * Healthy * Negative test of blood, nitrate or leucocytes in urinre * Waist line measurement 97-110 cm

Exclusion criteria

* Pregnant * Known allergy * Know bladder disease * Tendency of/clinicla symptoms of urinay infection * Abdominal or urinary surgery * Medical treatment

Design outcomes

Primary

MeasureTime frame
Intra Abdominal Pressure (IAP)
Mean Arterial Pressure (MAP)
Abdominal Perfussion Pressure (APP)

Secondary

MeasureTime frame
Comfort
Freedom of movement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026