PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds

Last updated: October 24, 2024
Sponsor: Royal College of Surgeons, Ireland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Standard wound dressing

Negative Pressure Wound Therapy

Clinical Study ID

NCT05977816
RCSI 22-092
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18 years or older

  • Patient requires visceral abdominal surgery via a midline laparotomy

  • Patients who can complete questionnaires

Exclusion

Exclusion Criteria:

• Patients who are unable to adhere to protocol requirements

Study Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: Standard wound dressing
Phase:
Study Start date:
July 14, 2023
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Portiuncula University Hospital

    Ballinasloe,
    Ireland

    Site Not Available

  • Mayo University Hospital

    Castlebar,
    Ireland

    Active - Recruiting

  • Our Lady of Lourdes Hospital Drogheda

    Drogheda,
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • Mater Misericordiae University Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • St James's Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • Tallaght University Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • University Hospital Galway

    Galway,
    Ireland

    Active - Recruiting

  • Letterkenny University Hospital

    Letterkenny,
    Ireland

    Active - Recruiting

  • University Hospital Limerick

    Limerick,
    Ireland

    Active - Recruiting

  • Sligo University Hospital

    Sligo,
    Ireland

    Active - Recruiting

  • University hospital Kerry

    Tralee,
    Ireland

    Site Not Available

  • University Hospital Waterford

    Waterford,
    Ireland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.