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

Primary Purpose

Wound Surgical, Wound Infection, Cosmesis

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Standard wound dressing
Sponsored by
Royal College of Surgeons, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Surgical focused on measuring Negative Pressure Wound Therapy, Surgical site Infection, Laparotomy, Post-operative Complications, Abdominal Incision, health economics, POSAS, CoPaQ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Portiuncula University Hospital
  • Mayo University Hospital
  • Our Lady of Lourdes Hospital Drogheda
  • Beaumont Hospital
  • Mater Misericordiae University Hospital
  • St James's HospitalRecruiting
  • University Hospital Galway
  • Letterkenny University Hospital
  • University Hospital Limerick
  • Sligo University Hospital
  • University hospital Kerry
  • University Hospital Waterford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Standard Wound dressing

Arm Description

The wound is dressed using negative pressure wound therapy.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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)
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)
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)
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)
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
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
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
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
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
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
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
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
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

Full Information

First Posted
February 13, 2023
Last Updated
August 3, 2023
Sponsor
Royal College of Surgeons, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT05977816
Brief Title
PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
Acronym
PROPEL-2
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal College of Surgeons, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Surgical, Wound Infection, Cosmesis
Keywords
Negative Pressure Wound Therapy, Surgical site Infection, Laparotomy, Post-operative Complications, Abdominal Incision, health economics, POSAS, CoPaQ

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
The wound is dressed using negative pressure wound therapy.
Arm Title
Standard Wound dressing
Arm Type
Active Comparator
Arm Description
After the skin is closed, the wound is covered using sterile standard gauze dressing.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Intervention Description
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Intervention Type
Other
Intervention Name(s)
Standard wound dressing
Intervention Description
Application of a standard wound dressing to the wound post laparotomy
Primary Outcome Measure Information:
Title
Rate of Surgical Site Infection (SSI)
Description
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.
Time Frame
1 month following surgery
Title
Rate of Surgical Site Infection (SSI)
Description
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.
Time Frame
3 months following surgery
Title
Rate of Surgical Site Infection (SSI)
Description
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.
Time Frame
6 months following surgery
Secondary Outcome Measure Information:
Title
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Description
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)
Time Frame
Baseline
Title
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Description
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)
Time Frame
1 month following surgery
Title
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Description
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)
Time Frame
3 months following surgery
Title
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Description
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)
Time Frame
6 months following surgery
Title
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Time Frame
1 month following surgery
Title
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Time Frame
3 months following surgery
Title
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Description
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
Time Frame
6 months following surgery
Title
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Description
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Time Frame
1 month
Title
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Description
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Time Frame
3 months
Title
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Description
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Time Frame
6 months
Title
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
Description
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
Time Frame
6 months
Title
Healthcare incremental cost- utility ratio
Description
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
Time Frame
6 months
Title
Healthcare cost-effectiveness ratio at 6 months
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Donohoe, PhD, FRCSI
Phone
35314103000
Email
Cldonohoe@stjames.ie
First Name & Middle Initial & Last Name or Official Title & Degree
Noel Donlon, PhD
Phone
35314103000
Email
donlonn@tcd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Donohoe, PhD, FRCSI
Organizational Affiliation
Trinity College Dublin /Royal College of Surgeons
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portiuncula University Hospital
City
Ballinasloe
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddie Myers, MD AFRCSI
Facility Name
Mayo University Hospital
City
Castlebar
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Barry, MD FRCSI
Facility Name
Our Lady of Lourdes Hospital Drogheda
City
Drogheda
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elanor Faul, BCh FRCSI
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnold Hill, MCh MD FRCSI
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronan Cahill, MD FRCSI
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Donohoe, PhD FRCSI
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sami Medani Abd ElWaheb, MBBS FRSCI
Facility Name
Letterkenny University Hospital
City
Letterkenny
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manvydas Varzgalis, MCh MD
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Fleming, MCh PhD
Facility Name
Sligo University Hospital
City
Sligo
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Caldwell, MD FRCSI
Facility Name
University hospital Kerry
City
Tralee
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pat Owens, MCh, MD
Facility Name
University Hospital Waterford
City
Waterford
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Neary, BAO FRCSI

12. IPD Sharing Statement

Plan to Share IPD
No

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

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