PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Negative Pressure Wound Therapy
DeviceApplication of negative-pressure wound therapy (NPWT) post major lower extremity amputation
Standard Wound Dressing
DeviceApplication of standard wound dressing post major lower extremity amputation
Treatment groups
728 Participants
are divided into 2 treatment groupsGroup A: Negative Pressure Wound Therapy.Experimental treatment 1 intervention
Group B: Standard Wound dressingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 month following surgerySecondary outcomes
1
Number of days to discharge
Length of time patient is in hospital from date of surgery to date of discharge
Time frame
6 months following surgery2
Rate of re-admission
Number of re-admissions to the hospital from date of surgery
Time frame
1 Month following surgery3
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)
Time frame
Baseline4
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)
Time frame
1 month following surgerySponsors and contacts
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Source ClinicalTrials.gov