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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Infection; Cosmesis; Wound Surgical
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Other: Standard wound dressing

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Donohoe, PhD, FRCSI; Phone Number: 35314103000; Email: Cldonohoe@stjames.ie
• Study Contact Backup: Name: Noel Donlon, PhD; Phone Number: 35314103000; Email: donlonn@tcd.ie

Study Locations

• Ireland
  • Castlebar, Ireland
    • Recruiting
    • Mayo University Hospital
    • Contact: Kevin Barry, MD FRCSI
  • Dublin, Ireland
    • Recruiting
    • Beaumont Hospital
    • Contact: Arnold Hill, MCh MD FRCSI
  • Dublin, Ireland
    • Recruiting
    • Mater Misericordiae University Hospital
    • Contact: Ronan Cahill, MD FRCSI
  • Dublin, Ireland
    • Recruiting
    • Tallaght University Hospital
    • Contact: Dara Kavanagh
  • Dublin, Ireland
    • Recruiting
    • St James's Hospital
    • Contact: Claire Donohoe
  • Galway, Ireland
    • Recruiting
    • University Hospital Galway
    • Contact: Stewart Walsh
  • Letterkenny, Ireland
    • Recruiting
    • Letterkenny University Hospital
    • Contact: Manvydas Varzgalis, MCh MD
  • Limerick, Ireland
    • Recruiting
    • University Hospital Limerick
    • Contact: Colin Peirce
  • Sligo, Ireland
    • Recruiting
    • Sligo University Hospital
    • Contact: Martin Caldwell, MD FRCSI
  • Tralee, Ireland
    • Not yet recruiting
    • University hospital Kerry
    • Contact: Pat Owens, MCh, MD
  • Waterford, Ireland
    • Recruiting
    • University Hospital Waterford
    • Contact: Peter Neary, BAO FRCSI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy; The wound is dressed using negative pressure wound therapy.	Device: Negative Pressure Wound Therapy; Application of a negative wound pressure therapy dressing to the wound post laparotomy
Active Comparator: Standard Wound dressing; After the skin is closed, the wound is covered using sterile standard gauze dressing.	Other: Standard wound dressing; Application of a standard wound dressing to the wound post laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Surgical Site Infection (SSI)	To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.	1 month following surgery
Rate of Surgical Site Infection (SSI)	To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.	3 months following surgery
Rate of Surgical Site Infection (SSI)	To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.	6 months following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	Baseline
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	1 month following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	3 months following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)	The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)	6 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	1 month following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	3 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)	The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6	6 months following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	1 month
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	3 months
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)	The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition	6 months
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings	Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings	6 months
Healthcare incremental cost- utility ratio	The incremental cost-effectiveness ratio at 6 months for NPWT vesus standard dressings for patients undergoing laparotomy.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression	6 months
Healthcare cost-effectiveness ratio at 6 months	Assessment of the cost-effectiveness ratio at 6 months between NPWT dressings compared to standard dressings. The criteria of effectiveness used will be; Length of hospital stay, requirement for return to theatre, requirement for critical care and number of dressings used	6 months

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Claire Donohoe, PhD, FRCSI, Trinity College Dublin /Royal College of Surgeons

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Laparotomy; Negative Pressure Wound Therapy; health economics; POSAS; Surgical site Infection; Post-operative Complications; Abdominal Incision; CoPaQ
• Additional Relevant MeSH Terms: Infections; Surgical Wound; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: RCSI 22-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No