PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Negative Pressure Wound Therapy, Standard Wound Dressing.
- Who it may be relevant to
- Registry conditions: Wound Surgical, Wound Infection, Cosmesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
Overview
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.
Interventions
- Device Negative Pressure Wound Therapy
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation - Device Standard Wound Dressing
Application of standard wound dressing post major lower extremity amputation
Primary outcome measures
- Presence of wound complications following amputation between NPWT and standard dressings [Time frame: 1 month following surgery]
Secondary outcome measures (12)
- Number of days to discharge [Time frame: 6 months following surgery]
- Rate of re-admission [Time frame: 1 Month following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: Baseline]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 1 month following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 3 months following surgery]
- Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L) [Time frame: 6 months following surgery]
- 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) [Time frame: 3 months following surgery]
- Wound-QoL (Questionnaire on quality of life with chronic wounds) [Time frame: 6 months following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Time frame: 1 Month following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Time frame: 3 Months following surgery]
- Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ) [Time frame: 6 Months following surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Ireland · 7 centers
- Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0 — Dublin
- St James's Hospital — Dublin
- St Vincents University Hospital — Dublin
- Tallaght University Hospital — Dublin
- University Hospital Galway — Galway
- University Hospital Limerick — Limerick
- University Hospital Waterford — Waterford
Identifiers
NCT: NCT06025253 · RCSI- PINTA