Healthy Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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