PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
PROPEL-2
PROPEL-2 Prophylactic Negative Pressure Wound Therapy (NPWT) in Laparotomy Wounds: a Randomised Controlled Trial Comparing Negative Pressure Wound Therapy to Standard Wound Management in Patients Following Midline Laparotomy
1 other identifier
interventional
2,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2023
CompletedStudy Start
First participant enrolled
July 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedOctober 26, 2024
October 1, 2024
2.5 years
February 13, 2023
October 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
1 month following surgery
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
3 months following surgery
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
6 months following surgery
Secondary Outcomes (13)
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Baseline
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
1 month following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
3 months following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
6 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
1 month following surgery
- +8 more secondary outcomes
Study Arms (2)
Negative Pressure Wound Therapy
EXPERIMENTALThe wound is dressed using negative pressure wound therapy.
Standard Wound dressing
ACTIVE COMPARATORAfter the skin is closed, the wound is covered using sterile standard gauze dressing.
Interventions
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Application of a standard wound dressing to the wound post laparotomy
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Patient requires visceral abdominal surgery via a midline laparotomy
- Patients who can complete questionnaires
You may not qualify if:
- Patients who are unable to adhere to protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
Related Publications (1)
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.
PMID: 39178168DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claire Donohoe, PhD, FRCSI
Trinity College Dublin /Royal College of Surgeons
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2023
First Posted
August 4, 2023
Study Start
July 14, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
October 26, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share