PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations (PINTA)
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ClinicalTrials.gov Identifier: NCT06025253 |
Recruitment Status :
Not yet recruiting
First Posted : September 6, 2023
Last Update Posted : December 4, 2023
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Sponsor:
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Wound Surgical Wound Infection Cosmesis | Device: Negative Pressure Wound Therapy Device: Standard Wound Dressing | Not Applicable |
Show detailed description
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 728 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations |
Estimated Study Start Date : | December 1, 2023 |
Estimated Primary Completion Date : | December 1, 2026 |
Estimated Study Completion Date : | December 1, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Wounds and Injuries
Arm | Intervention/treatment |
---|---|
Experimental: Negative Pressure Wound Therapy.
Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation
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Device: Negative Pressure Wound Therapy
Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation |
Active Comparator: Standard Wound dressing
Application of sterile standard gauze dressing to the wound post major lower extremity amputation
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Device: Standard Wound Dressing
Application of standard wound dressing post major lower extremity amputation |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
No Contacts or Locations Provided
Responsible Party: | Royal College of Surgeons, Ireland |
ClinicalTrials.gov Identifier: | NCT06025253 |
Other Study ID Numbers: |
RCSI-PINTA |
First Posted: | September 6, 2023 Key Record Dates |
Last Update Posted: | December 4, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Royal College of Surgeons, Ireland:
Negative Pressure Wound Therapy Surgical Site Infection Post-operative Complications Abdominal Incision Health Economics |
Additional relevant MeSH terms:
Wound Infection Wounds and Injuries Surgical Wound Infections |