Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385892
Status:
TERMINATED
Last Update Posted:
2006-10-11
First Post:
2006-10-09
Brief Title:
Safety Study of Textile Binder for Abdominal Compression
Sponsor:
Coloplast AS
Organization:
Coloplast AS
Study Overview
Official Title:
Feasibility Study DK150OS Testing of Compression Textile A Safety Study Among Healthy Volonteers
Status:
TERMINATED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 80 and 167 mmHg mean 105 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 40 mmHg -14 or 393 -1461
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
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 80 and 167 mmHg mean 105 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 40 mmHg -14 or 393 -1461
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None