NCT06025253

PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 728 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Surgical
• Wound Infection
• Cosmesis

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
DEVICE	Standard Wound Dressing	Application of standard wound dressing post major lower extremity amputation

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-12-20
• First posted: 2023-09-06
• Last updated: 2024-10-18

Locations

7 sites across 1 country: Ireland