PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations (PINTA)

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

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Cosmesis; Wound Surgical
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Device: Standard Wound Dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 728
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stewart Walsh; Phone Number: 353 915 2422; Email: stewartredmond.walsh@universityofgalway.ie
• Study Contact Backup: Name: Megan Foley; Phone Number: 353 915 2422; Email: meganpfoley@rcsi.com

Study Locations

• Ireland
  • Dublin, Ireland
    • Not yet recruiting
    • Tallaght University Hospital
    • Contact: Emily Boyle
  • Dublin, Ireland, H91 YR71
    • Not yet recruiting
    • Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0
    • Contact: Daragh Moneley; Phone Number: (01) 8093131
    • Principal Investigator: Daragh Moneley
  • Dublin, Ireland
    • Not yet recruiting
    • St Jamess Hospital
    • Contact: Zenia Martin
  • Dublin, Ireland
    • Not yet recruiting
    • St Vincents University Hospital
    • Contact: Hillary Hurley
  • Galway, Ireland
    • Recruiting
    • University Hospital Galway
    • Contact: Stewart Walsh
  • Limerick, Ireland
    • Not yet recruiting
    • University Hospital Limerick
    • Contact: Zeeshan Ahmed
  • Waterford, Ireland
    • Recruiting
    • University Hospital Waterford
    • Contact: Gergely Gosi; Phone Number: 051-848303

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy.; Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation	Device: Negative Pressure Wound Therapy; Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
Active Comparator: Standard Wound dressing; Application of sterile standard gauze dressing to the wound post major lower extremity amputation	Device: Standard Wound Dressing; Application of standard wound dressing post major lower extremity amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of wound complications following amputation between NPWT and standard dressings	Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.	1 month following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	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)	Baseline
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	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)	1 month following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	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)	3 months following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	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 months following surgery
Number of days to discharge	Length of time patient is in hospital from date of surgery to date of discharge	6 months following surgery
Rate of re-admission	Number of re-admissions to the hospital from date of surgery	1 Month following surgery
Wound-QoL (Questionnaire on quality of life with chronic wounds)	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.	1 month following surgery
Wound-QoL (Questionnaire on quality of life with chronic wounds)	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.	3 months following surgery
Wound-QoL (Questionnaire on quality of life with chronic wounds)	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.	6 months following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	1 Month following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	3 Months following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	6 Months following surgery
Rate of Re-operation	Number of re-operations undertaken from date of surgery	1 Month following surgery

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Stewart Walsh, Prof, University Hospital Galway (UHG)

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Negative Pressure Wound Therapy; Health Economics; Post-operative Complications; CoPaQ; WoundQol
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Surgical Wound; Wound Infection
• Other Study ID Numbers: RCSI- PINTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No