PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

728 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-20

Brief Summary

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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.

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Detailed Description

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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

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Wound Surgical Wound Infection Cosmesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Negative Pressure Wound Therapy.

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

Group Type EXPERIMENTAL

Negative Pressure Wound Therapy

Intervention Type DEVICE

Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation

Standard Wound dressing

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

Group Type ACTIVE_COMPARATOR

Standard Wound Dressing

Intervention Type DEVICE

Application of standard wound dressing post major lower extremity amputation

Interventions

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Negative Pressure Wound Therapy

Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation

Intervention Type DEVICE

Standard Wound Dressing

Application of standard wound dressing post major lower extremity amputation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stewart Walsh, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Galway (UHG)

Locations

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