PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations (PINTA)

• ClinicalTrials.gov Identifier: NCT06025253
• Recruitment Status: Not yet recruiting
• First Posted: September 6, 2023
• Last Update Posted: December 4, 2023
• Sponsor: Royal College of Surgeons, Ireland
• Information provided by (Responsible Party): Royal College of Surgeons, Ireland

Tracking Information

• First Submitted Date: August 29, 2023
• First Posted Date: September 6, 2023
• Last Update Posted Date: December 4, 2023
• Estimated Study Start Date: December 1, 2023
• Estimated Primary Completion Date: December 1, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 28, 2023)

Number of patients with a wound complication of the amputation stump, including wound infection, dehiscence, seroma, haematoma and stump necrosis. [ Time Frame: 1 month post surgery ]

The Centre for Disease Control and Prevention definitions of surgical site infection will be used.

Original Primary Outcome Measures (submitted: August 29, 2023)

Any wound complication of the amputation stump, including wound infection, dehiscence, seroma, haematoma and stump necrosis. [ Time Frame: 1 month post surgery ]

The Centre for Disease Control and Prevention definitions of surgical site infection will be used.

Current Secondary Outcome Measures (submitted: November 28, 2023)

• Number of days to discharge [ Time Frame: 6 months ]
  The length of time the patient is in hospital from date of surgery to date of discharge
• Number of patients who require Re-operations within 1 month of surgery [ Time Frame: 1 Month ]
  Any re-operations undertaken

Original Secondary Outcome Measures (submitted: August 29, 2023)

• Number of days to discharge [ Time Frame: 6 months ]
  The length of time the patient is in hospital from date of surgery to date of discharge
• Re-operations [ Time Frame: 1 Month ]
  Any re-operations undertaken

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
• Official Title: Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations
• 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 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. Negative pressure wound therapy (NPWT) removes excess fluid from wounds as well as limiting bacterial access.

Negative pressure dressings consistent of an open cell solid foam, placed on top of the incision and then covered with a semipermeable membrane. A sealed tube connects the foam to a pump to create a partial vacuum over the wound. This negative pressure leads to a sealed environment which prevents bacterial migration into the wound while removing blood and serous exudate. Single-use NPWT systems (such as Smith & Nephew's PICOTM and Acelity's PrevenaTM) are now widely available. The systems can be applied and left in place for up to seven days.

Prophylactic NPWT in the setting of closed surgical incisions has been widely evaluated. The most recent Cochrane review analysed data from 62 randomised controlled trials (RCTs) and 6 economic studies. Data were reported from 13,340 participants, undergoing a wide range of procedures (gastrointestinal, gynaecological, vascular, orthopaedic and cardiothoracic). The review was concluded with moderate certainty that prophylactic NPWT reduces SSI but not wound dehiscence. There was a possibility that prophylactic NPWT reduces mortality although the confidence intervals include the possibility of harm. Cost effectiveness studies produced differing results in differing settings with no high-grade evidence of cost efficacy. However, studies specifically investigating the impact of NPWT on closed incision major LEAs are scarce.

Early results from a pilot study of prospective, multi-centre, two-arm, randomized controlled trial comparing NPWT to standard dressings after above knee amputations (AKA) and below-knee amputations (BKA) reported promising results. In this initial review of 43 patients, NPWT reduced the wound complication rates at 30 days, with complications noted in 5 of 21 controls (23.8%) and 1 of 22 (4.5%) in the treatment group (p=0.068). Despite this, the absence of robust cost effectiveness data to support the routine use of NPWT is of concern. NPWT is considerably more expensive than traditional dressings (approximately £120-145 versus £4 for a standard dressing). In addition, the Cochrane reviewers noted that pain and health-related quality of life were not reported by most of their included RCTs.

Most studies randomised patients at high-risk for wound complications but did not always define high-risk clearly. Finally, the definition of surgical site infection varied amongst included studies. In particular, it remains unclear whether NPWT reduces all wound infections, superficial infections alone or deep infections.

Negative-pressure wound dressings rely on a robust seal around the wound to function. This can be difficult to achieve on the relatively irregular shape of a major limb amputation wound. Seal failures often result in dressings changes, substantially increasing associated costs. Prospective evaluation of wound complications in a trial setting utilising standardised criteria will generate a robust baseline rate upon which to generate a sample size calculation for a full trial.

We propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Wound Surgical
• Wound Infection
• Cosmesis

Intervention

• 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

Study Arms

• Experimental: Negative Pressure Wound Therapy.
  Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation
  Intervention: Device: Negative Pressure Wound Therapy
• Active Comparator: Standard Wound dressing
  Application of sterile standard gauze dressing to the wound post major lower extremity amputation
  Intervention: Device: Standard Wound Dressing

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 29, 2023): 728
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2026
• Estimated Primary Completion Date: December 1, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06025253
• Other Study ID Numbers: RCSI-PINTA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Royal College of Surgeons, Ireland
• Original Responsible Party: Same as current
• Current Study Sponsor: Royal College of Surgeons, Ireland
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Royal College of Surgeons, Ireland
• Verification Date: August 2023