Clinical trial NCT05977816: PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Surgical
Wound Infection
Cosmesis
Keywords: Negative Pressure Wound Therapy
Surgical site Infection
Laparotomy
Post-operative Complications
Abdominal Incision
health economics
POSAS
CoPaQ
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Rate of Surgical Site Infection (SSI)
timeFrame: 1 month following surgery
measure: Rate of Surgical Site Infection (SSI)
timeFrame: 3 months following surgery
measure: Rate of Surgical Site Infection (SSI)
timeFrame: 6 months following surgery
Secondary outcomes:
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: Baseline
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 1 month following surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 3 months following surgery
measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
timeFrame: 6 months following surgery
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 1 month following surgery
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 3 months following surgery
measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 6 months following surgery
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 1 month
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 3 months
measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
timeFrame: 6 months
measure: Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
timeFrame: 6 months
measure: Healthcare incremental cost- utility ratio
timeFrame: 6 months
measure: Healthcare cost-effectiveness ratio at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Castlebar
country: Ireland
facility: Mayo University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: Tallaght University Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Letterkenny
country: Ireland
facility: Letterkenny University Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Sligo
country: Ireland
facility: Sligo University Hospital
city: Tralee
country: Ireland
facility: University hospital Kerry
city: Waterford
country: Ireland
facility: University Hospital Waterford
Study officials:
affiliation: Trinity College Dublin /Royal College of Surgeons
name: Claire Donohoe, PhD, FRCSI
role: PRINCIPAL_INVESTIGATOR
References: