Clinical trial NCT06025253: PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
Official title: Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Surgical
Wound Infection
Cosmesis
Keywords: Negative Pressure Wound Therapy
Surgical Site Infection
Post-operative Complications
Health Economics
CoPaQ
WoundQol
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Presence of wound complications following amputation between NPWT and standard dressings
timeFrame: 1 month following surgery
Secondary outcomes:
measure: Number of days to discharge
timeFrame: 6 months following surgery
measure: Rate of re-admission
timeFrame: 1 Month following surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: Baseline
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 1 month following surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 3 months following surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 6 months following surgery
measure: Wound-QoL (Questionnaire on quality of life with chronic wounds)
timeFrame: 1 month following surgery
measure: Wound-QoL (Questionnaire on quality of life with chronic wounds)
timeFrame: 3 months following surgery
measure: Wound-QoL (Questionnaire on quality of life with chronic wounds)
timeFrame: 6 months following surgery
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 1 Month following surgery
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 3 Months following surgery
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 6 Months following surgery
measure: Rate of Re-operation
timeFrame: 1 Month following surgery
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital, Beaumont rd,Dublin 9, D09V2N0
city: Dublin
country: Ireland
facility: St Jamess Hospital
city: Dublin
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
affiliation: University Hospital Galway (UHG)
name: Stewart Walsh, Prof
role: PRINCIPAL_INVESTIGATOR
References: