# Prophylactic Incisional Negative Pressure wound therapy (NPWT) for major Amputations (PINTA): protocol for randomized controlled trial of single-use NPWT devices for closed-incision major lower extremity amputations

## TL;DR

This study tests if using a special wound therapy device after major leg amputations reduces complications compared to regular dressings.

## Contribution

The study introduces a protocol for a large-scale randomized trial evaluating prophylactic NPWT in major amputations, an area with limited evidence.

## Key findings

- The trial will assess wound complication rates in patients receiving NPWT versus standard dry dressings.
- Secondary outcomes include reoperation rates, hospital stay duration, cost-effectiveness, and quality of life.
- The study is powered to detect meaningful differences with a target of 728 patients.

## Abstract

Major lower extremity amputations are frequently performed for end-stage peripheral arterial disease and progressive diabetic foot complications. Wound complications after amputation affect up to one-third of limbs. The patient cohort undergoing amputation are typically high risk for poor wound healing, often with unmodifiable risk factors in an urgent clinical setting. Incisional negative pressure wound therapy (NPWT) has been shown to reduce wound complications in other high-risk populations. This randomized controlled trial investigates whether prophylactic NPWT reduces wound complications in patients after major amputation compared with standard dry dressings.

This protocol describes a prospective, multicentre, randomized controlled trial with an internal pilot recruiting patients undergoing major lower extremity amputation for any indication. Limbs will be randomized to receive either a single-use NPWT device on their closed surgical incision or a dry dressing. The primary clinical outcome is the rate of wound complications. Secondary outcomes include reoperation rates, length of hospital stay, cost-effectiveness of NPWT, and patient-reported quality of life. Follow-up will continue to 6 months after surgery. The initial pilot phase has a recruitment target of 96 limbs, whereas an estimated 728 patients will be required to power a definitive trial adequately.

This trial aims to supplement the existing poor-quality data on this important aspect of care and equip healthcare professionals to make cost-effective decisions regarding postoperative wound management.

Protocol for a pragmatic randomized controlled trial comparing prophylactic negative pressure wound therapy devices with standard care for closed-incision major lower extremity amputations. Outcomes include composite wound complications at 30 days, patient-reported outcomes on quality of life and wound-related quality of life, and cost-effectiveness. Adequately powered to 90% with a target sample size of 728 patients.