Wound SurgicalPINTANCT06025253
PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
A study testing Negative Pressure Wound Therapy and Standard Wound Dressing in people with Wound Surgical and Wound Infection, run by Royal College of Surgeons, Ireland at 7 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Surgical, Wound Infection, Cosmesis
- What is being tested?
- Negative Pressure Wound Therapy and Standard Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 7 sitesIreland
- Study dates
- 1 Mar 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Ireland7 sites, 7 recruiting
- Recruiting
Beaumont Hospital, Beaumont Rd,Dublin 9, D09V2N0
Dublin, Dublin, H91 YR71
Daragh Moneley, (01) 8093131
Daragh Moneley
- Recruiting
St James's Hospital
Dublin
Zenia Martin
- Recruiting
St Vincents University Hospital
Dublin
Hillary Hurley
- Recruiting
Tallaght University Hospital
Dublin
Emily Boyle
- Recruiting
University Hospital Galway
Galway
Stewart Walsh
- Recruiting
University Hospital Limerick
Limerick
Zeeshan Ahmed
- Recruiting
University Hospital Waterford
Waterford
Gergely Gosi, 051-848303
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Surgical, Wound Infection, Cosmesis
- Being tested
- Negative Pressure Wound Therapy, Standard Wound Dressing
- Keywords
- Negative Pressure Wound Therapy, Surgical Site Infection, Post-operative Complications, Health Economics, CoPaQ, WoundQol
- Medical subject headings
- Surgical Wound, Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
Standard Wound DressingDevice
Application of standard wound dressing post major lower extremity amputation
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy. | Experimental | Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation Receives: Device: Negative Pressure Wound Therapy |
| Standard Wound dressing | Active comparator | Application of sterile standard gauze dressing to the wound post major lower extremity amputation Receives: Device: Standard Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month following surgery
Secondary outcomes (13)
Number of days to discharge
Length of time patient is in hospital from date of surgery to date of discharge
Measured: 6 months following surgery
Rate of re-admission
Number of re-admissions to the hospital from date of surgery
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 6 Months following surgery
Rate of Re-operation
Number of re-operations undertaken from date of surgery
Measured: 1 Month following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Mar 2024
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stewart Walsh, Prof, Principal investigator, University Hospital Galway (UHG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025253
- Sponsor's protocol ID
- RCSI- PINTA
- Acronym
- PINTA
- Status last verified
- Jul 2026
- First submitted
- 29 Aug 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
- ClinicalTrials.gov ID
- NCT06025253
- Acronym / sponsor ID
- PINTA / RCSI- PINTA
- Conditions
- Wound Surgical, Wound Infection, Cosmesis
- Keywords
- Negative Pressure Wound Therapy, Surgical Site Infection, Post-operative Complications, Health Economics, CoPaQ, WoundQol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy. | Experimental | Device: Negative Pressure Wound TherapyApplication of a negative wound pressure therapy dressing to the wound post major lower extremity amputation |
| Standard Wound dressing | Active comparator | Device: Standard Wound DressingApplication of sterile standard gauze dressing to the wound post major lower extremity amputation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyApplication of negative-pressure wound therapy (NPWT) post major lower extremity amputation | Device | Negative Pressure Wound Therapy. |
| Standard Wound DressingApplication of standard wound dressing post major lower extremity amputation | Device | Standard Wound dressing |
Primary outcome
Presence of wound complications following amputation between NPWT and standard dressings
Time frame: 1 month following surgery
Infection(deep or superficial), wound dehiscence, partial (fascia intact), complete (fascia breached), seroma, haematoma or stump necrosis.
13 secondary outcomes
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
Rate of Re-operation
Time frame: 1 Month following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stewart Walsh, Prof principal investigator
University Hospital Galway (UHG)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Standard Wound Dressing in people with Wound Surgical and Wound Infection, run by Royal College of Surgeons, Ireland at 7 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stewart Walsh (353 915 2422, stewartredmond.walsh@universityofgalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of wound complications following amputation between NPWT and standard dressings (time frame: 1 month following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.