PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Not Applicable

Recruiting

• Conditions: Cosmesis; Wound Infection; Wound Surgical

• Registration Number: NCT06025253
• Lead Sponsor: Royal College of Surgeons, Ireland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Study First Posted: 2023-09-06
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-03-01
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 728

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0; 🇮🇪 Dublin, Ireland

St Jamess Hospital; 🇮🇪 Dublin, Ireland

St Vincents University Hospital; 🇮🇪 Dublin, Ireland

Tallaght University Hospital; 🇮🇪 Dublin, Ireland

University Hospital Galway; 🇮🇪 Galway, Ireland

University Hospital Limerick; 🇮🇪 Limerick, Ireland

University Hospital Waterford; 🇮🇪 Waterford, Ireland