Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025253
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2023-08-29
Brief Title:
PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
Sponsor:
Royal College of Surgeons Ireland
Organization:
Royal College of Surgeons Ireland
Study Overview
Official Title:
Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
Status:
RECRUITING
Status Verified Date:
2024-03
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:
PINTA
Brief Summary:
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes This study is taking place to investigate if Negative Pressure Wound Therapy NPWT dressings reduces Surgical Site Infections post surgical complications and improves scar appearance compared to standard dressings
Detailed Description:
Many factors influence the risk of wound complications Notably the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing Patient factors such as smoking diabetes obesity malnutrition and chronic kidney disease are non-modifiable particularly in the short-term setting However surgical factors may be altered in an effort to reduce the risk of wound complications
One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion The type of dressing may influence factors such as bacterial access to the wound the development of collections of blood or fluid in the wound or fluid oozing from the wound Collectively these wound factors increase the risk of wound infection Therefore dressings which reduce these factors have the potential to reduce wound breakdown thereby reducing the burden for patients and healthcare systems
The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence wound healing complications and scar appearance patient quality of life and financial impact on the patient and healthcare system
One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion The type of dressing may influence factors such as bacterial access to the wound the development of collections of blood or fluid in the wound or fluid oozing from the wound Collectively these wound factors increase the risk of wound infection Therefore dressings which reduce these factors have the potential to reduce wound breakdown thereby reducing the burden for patients and healthcare systems
The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence wound healing complications and scar appearance patient quality of life and financial impact on the patient and healthcare system
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