PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Royal College of Surgeons, Ireland

Status: Enrolling

Conditions: Cosmesis; Wound Surgical; Wound Infection

Treatments: Device: Standard Wound Dressing; Device: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06025253

RCSI- PINTA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 728 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or older;
• Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
• Patients with primary closure of the surgical incision using either interrupted or continuous sutures

Exclusion criteria

• Patients <18 years;
• Women who are pregnant and/or breast-feeding;
• Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
• Patients with amputations where skin glue is the only means of skin closure
• Patients with a clinically absent femoral pulse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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728 participants in 2 patient groups

Negative Pressure Wound Therapy.

Experimental group

Description:

Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation

Treatment:

Device: Negative Pressure Wound Therapy

Standard Wound dressing

Active Comparator group

Description:

Application of sterile standard gauze dressing to the wound post major lower extremity amputation

Treatment:

Device: Standard Wound Dressing