Safety Study of Textile Binder for Abdominal Compression

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00385892
• Other study ID #: DK150OS
• Status: Terminated
• Phase: N/A
• First received: October 9, 2006
• Last updated: October 10, 2006
• Start date: August 2005
• Est. completion date: October 2005

Study information

• Verified date: October 2006
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Abdominal binder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Abdominal Pressure (IAP)
Primary	Mean Arterial Pressure (MAP)
Primary	Abdominal Perfussion Pressure (APP)
Secondary	Comfort
Secondary	Freedom of movement