Using Negative Pressure Wound Therapy for Laparotomy Wounds
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
This study is testing if a special type of dressing that uses negative pressure can help people heal better and have fewer infections after surgery on their abdomen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 11 sites (Castlebar and 10 other locations) |
| Trial ID | NCT05977816 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Negative Pressure Wound Therapy (NPWT) dressings in reducing surgical site infections and improving wound healing and scar appearance in patients undergoing laparotomy. The NPWT dressings work by removing and absorbing fluid from the wound, which may lead to better outcomes compared to standard dressings. The study will also analyze the cost implications and gather patient-reported quality of life data. By addressing post-operative complications, the research aims to enhance recovery and reduce healthcare costs associated with laparotomy wounds.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require visceral abdominal surgery via a midline laparotomy and can complete questionnaires.
Not a fit: Patients unable to adhere to protocol requirements or those with contraindications for NPWT may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical site infections and improve recovery outcomes for patients undergoing abdominal surgery.
How similar studies have performed: Previous studies have shown promise with NPWT in various surgical settings, suggesting potential for success in this application as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years or older * Patient requires visceral abdominal surgery via a midline laparotomy * Patients who can complete questionnaires Exclusion Criteria: • Patients who are unable to adhere to protocol requirements
Where this trial is running
Castlebar and 10 other locations
- Mayo University Hospital — Castlebar, Ireland (Recruiting)
- Beaumont Hospital — Dublin, Ireland (Recruiting)
- Mater Misericordiae University Hospital — Dublin, Ireland (Recruiting)
- St James's Hospital — Dublin, Ireland (Recruiting)
- Tallaght University Hospital — Dublin, Ireland (Recruiting)
- University Hospital Galway — Galway, Ireland (Recruiting)
- Letterkenny University Hospital — Letterkenny, Ireland (Recruiting)
- University Hospital Limerick — Limerick, Ireland (Recruiting)
- Sligo University Hospital — Sligo, Ireland (Recruiting)
- University hospital Kerry — Tralee, Ireland (Not_yet_recruiting)
- University Hospital Waterford — Waterford, Ireland (Recruiting)
Study contacts
- Principal investigator: Claire Donohoe, PhD, FRCSI — Trinity College Dublin /Royal College of Surgeons
- Study coordinator: Claire Donohoe, PhD, FRCSI
- Email: Cldonohoe@stjames.ie
- Phone: 35314103000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.