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

Royal College of Surgeons, Ireland

Status: Enrolling

Conditions: Cosmesis; Wound Surgical; Wound Infection

Treatments: Device: Negative Pressure Wound Therapy; Other: Standard wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05977816

RCSI 22-092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Negative Pressure Wound Therapy

Experimental group

Description:

The wound is dressed using negative pressure wound therapy.

Treatment:

Device: Negative Pressure Wound Therapy

Standard Wound dressing

Active Comparator group

Description:

After the skin is closed, the wound is covered using sterile standard gauze dressing.

Treatment:

Other: Standard wound dressing