NCT05977816

PROPEL-2: Prophylactic Negative Pressure Wound Therapy in 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might reduce surgical site infections, improve wound healing and improve scar appearance compared to using standard dressings. 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

• Wound Surgical
• Wound Infection
• Cosmesis

Interventions

Type	Name	Description
DEVICE	Negative Pressure Wound Therapy	Application of a negative wound pressure therapy dressing to the wound post laparotomy
OTHER	Standard wound dressing	Application of a standard wound dressing to the wound post laparotomy

Timeline

• Start date: 2023-07-14
• Primary completion: 2026-01-01
• Completion: 2026-07-01
• First posted: 2023-08-04
• Last updated: 2024-10-26

Locations

11 sites across 1 country: Ireland