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NCT Number: NCT06025253

PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

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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Key information

Conditions

Wound Surgical Cosmesis Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative pressure wound therapy

Device

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

Standard Wound Dressing

Device

Application of standard wound dressing post major lower extremity amputation

Primary outcomes

  1. Presence of wound complications following amputation between NPWT and standard dressings

    Time frame: 1 month following surgery

    Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.

Secondary outcomes

  1. Number of days to discharge

    Time frame: 6 months following surgery

    Length of time patient is in hospital from date of surgery to date of discharge

  2. Rate of re-admission

    Time frame: 1 Month following surgery

    Number of re-admissions to the hospital from date of surgery

  3. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: Baseline

    The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  4. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 1 month following surgery

    The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  5. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 3 months following surgery

    The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  6. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 6 months following surgery

    The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  7. Wound-QoL (Questionnaire on quality of life with chronic wounds)

    Time frame: 1 month following surgery

    Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.

  8. Wound-QoL (Questionnaire on quality of life with chronic wounds)

    Time frame: 3 months following surgery

    Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.

  9. Wound-QoL (Questionnaire on quality of life with chronic wounds)

    Time frame: 6 months following surgery

    Wound-QoL (Questionnaire on quality of life with chronic wounds) measures the disease-specific, health-related quality of life of patients with chronic wounds. It can be used in clinical and observational studies as well as in daily practice. The primary endpoint is the reduction of more than 0.4 points in the overall score of the Wound-Qol quality of life questionnaire between D0 and D14.

  10. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 1 Month following surgery

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  11. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 3 Months following surgery

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  12. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 6 Months following surgery

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  13. Rate of Re-operation

    Time frame: 1 Month following surgery

    Number of re-operations undertaken from date of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Foley

CONTACT

[email protected]

353 915 2422

Stewart Walsh

CONTACT

[email protected]

353 915 2422

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study title

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

Acronym: PINTA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 6, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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