PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
NCT ID: NCT05977816
Last Updated: 2024-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2023-07-14
2026-07-31
Brief Summary
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Detailed Description
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Data is limited in the application of NPWT dressings to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.
In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc., surgical site complications continue to represent a huge healthcare burden.
The Investigators are conducting this study to determine whether NPWT dressings reduce surgical site infections, improve wound healing and scar appearance. This study will also involve a cost-based analysis and seek information from patients on their quality of life. Results from this study will provide evidence on whether these dressings should be used as standard of care for management of surgical laparotomy wounds.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Negative Pressure Wound Therapy
The wound is dressed using negative pressure wound therapy.
Negative Pressure Wound Therapy
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Standard Wound dressing
After the skin is closed, the wound is covered using sterile standard gauze dressing.
Standard wound dressing
Application of a standard wound dressing to the wound post laparotomy
Interventions
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Negative Pressure Wound Therapy
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Standard wound dressing
Application of a standard wound dressing to the wound post laparotomy
Eligibility Criteria
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Inclusion Criteria
* Patient requires visceral abdominal surgery via a midline laparotomy
* Patients who can complete questionnaires
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Royal College of Surgeons, Ireland
OTHER
Responsible Party
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Principal Investigators
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Claire Donohoe, PhD, FRCSI
Role: PRINCIPAL_INVESTIGATOR
Trinity College Dublin /Royal College of Surgeons
Locations
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Mayo University Hospital
Castlebar, , Ireland
Beaumont Hospital
Dublin, , Ireland
Mater Misericordiae University Hospital
Dublin, , Ireland
St James's Hospital
Dublin, , Ireland
Tallaght University Hospital
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
Letterkenny University Hospital
Letterkenny, , Ireland
University Hospital Limerick
Limerick, , Ireland
Sligo University Hospital
Sligo, , Ireland
University hospital Kerry
Tralee, , Ireland
University Hospital Waterford
Waterford, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Kevin Barry, MD FRCSI
Role: primary
Arnold Hill, MCh MD FRCSI
Role: primary
Ronan Cahill, MD FRCSI
Role: primary
Claire Donohoe
Role: primary
Dara Kavanagh
Role: primary
Stewart Walsh
Role: primary
Manvydas Varzgalis, MCh MD
Role: primary
Colin Peirce
Role: primary
Martin Caldwell, MD FRCSI
Role: primary
Pat Owens, MCh, MD
Role: primary
Peter Neary, BAO FRCSI
Role: primary
References
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Davey MG, Donlon NE, Walsh SR, Donohoe CL; PROPEL-2 Trial Collaborators. Prophylactic negative pressure wound therapy (NPWT) in laparotomy wounds (PROPEL-2): protocol for a randomized clinical trial. BJS Open. 2024 Jul 2;8(4):zrae081. doi: 10.1093/bjsopen/zrae081.
Other Identifiers
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RCSI 22-092
Identifier Type: -
Identifier Source: org_study_id
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