Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Brief Title:
Effect of Negative Wound Pressure on PS
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Randomised Clinical Trial of the Negative Pressure Wound Therapy Versus Conventional Dressing for Pressure Ulcers Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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 study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating i reduction of wound surface area and depth ii removal of slough and formation of granulation tissue
Detailed Description:
Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group
its 3 groups
Group A conventional dressing
acting bypreventing pus the findings from the review indicate that decreasing frictional forces transmitted to the patients skin is achieved by use of a dressing with an outer surface made from a low friction material
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound Dressing changes will be performed once or twice daily depending on the soakage of the dressing
Group B negative pressure wound therapy using the electronic-vac
It is believed that the negative pressure assists in removal of interstitial fluid decreasing oedema increasing blood flow and reducing tissue bacterial levels in addition mechanical deformation of cells is thought to result in protein and matrix molecule synthesis which increases the rate of cell proliferation and granulation tissue formation this in turn may promote healing
We will place a nonadherent contact layer such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape The dressing will be connected to the machine through tubing that was connected to the canister Continuous pressure of 200 mm Hg will be applied The dressing will be changed three times a week Group C negative pressure wound therapy using the Romo-vac The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus We will Place nonadherent contact layer such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakageleakage
its 3 groups
Group A conventional dressing
acting bypreventing pus the findings from the review indicate that decreasing frictional forces transmitted to the patients skin is achieved by use of a dressing with an outer surface made from a low friction material
The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound Dressing changes will be performed once or twice daily depending on the soakage of the dressing
Group B negative pressure wound therapy using the electronic-vac
It is believed that the negative pressure assists in removal of interstitial fluid decreasing oedema increasing blood flow and reducing tissue bacterial levels in addition mechanical deformation of cells is thought to result in protein and matrix molecule synthesis which increases the rate of cell proliferation and granulation tissue formation this in turn may promote healing
We will place a nonadherent contact layer such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape The dressing will be connected to the machine through tubing that was connected to the canister Continuous pressure of 200 mm Hg will be applied The dressing will be changed three times a week Group C negative pressure wound therapy using the Romo-vac The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus We will Place nonadherent contact layer such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakageleakage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None