Prophylactic Negative Wound Therapy in Laparotomy Wounds. (PROPEL)
Primary Purpose
Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
Status
Unknown status
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Smith & Nephew PICO Negative wound pressure versus standard dresing
PREVENA Negative pressure wound versus standard dressing
Sponsored by
About this trial
This is an interventional prevention trial for Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
Eligibility Criteria
Inclusion Criteria:
- All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.
Exclusion Criteria:
- Pregnant patients and those undergoing re-look laparotomies are to be excluded.
Sites / Locations
- St. James' Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Simple dressing
PICO Dressing
PREVENA Dressing
Arm Description
Standard, waterproof dressing applied to wound
Negative Wound pressure applied second cohort
Negative wound presure applied to third cohort
Outcomes
Primary Outcome Measures
superficial site infection via southampton scoring system (higher score - worse outcome)
seroma/haematoma/abscess formation
Wound Dehisence
disruption of wound continuity
Secondary Outcome Measures
Wound healing/Cosmesis
scar healing (via observer scar assesment scale - higher score wore outcome)
Length of hospital stay
wound complications causing prolonged hospital stay
home care therapy
lenth of home care dressings
Full Information
NCT ID
NCT03871023
First Posted
March 7, 2019
Last Updated
September 17, 2019
Sponsor
St. James's Hospital, Ireland
1. Study Identification
Unique Protocol Identification Number
NCT03871023
Brief Title
Prophylactic Negative Wound Therapy in Laparotomy Wounds.
Acronym
PROPEL
Official Title
The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. James's Hospital, Ireland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.
The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.
Detailed Description
In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.
However, data is limited in its application 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.
Aim;
1. To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 separate treatment arms
Masking
Investigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Simple dressing
Arm Type
Active Comparator
Arm Description
Standard, waterproof dressing applied to wound
Arm Title
PICO Dressing
Arm Type
Active Comparator
Arm Description
Negative Wound pressure applied second cohort
Arm Title
PREVENA Dressing
Arm Type
Active Comparator
Arm Description
Negative wound presure applied to third cohort
Intervention Type
Device
Intervention Name(s)
Smith & Nephew PICO Negative wound pressure versus standard dresing
Intervention Description
To investigate if negative wound pressure improves wound outcome
Intervention Type
Device
Intervention Name(s)
PREVENA Negative pressure wound versus standard dressing
Intervention Description
To investigate if negative wound pressure improves wound outcome
Primary Outcome Measure Information:
Title
superficial site infection via southampton scoring system (higher score - worse outcome)
Description
seroma/haematoma/abscess formation
Time Frame
5 days
Title
Wound Dehisence
Description
disruption of wound continuity
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Wound healing/Cosmesis
Description
scar healing (via observer scar assesment scale - higher score wore outcome)
Time Frame
week 6 post op
Title
Length of hospital stay
Description
wound complications causing prolonged hospital stay
Time Frame
30 days
Title
home care therapy
Description
lenth of home care dressings
Time Frame
30days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.
Exclusion Criteria:
Pregnant patients and those undergoing re-look laparotomies are to be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noel E Donlon
Phone
00353863557726
Ext
00353863557726
Email
donlonn@tcd.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel E Donlon
Organizational Affiliation
St. James's Hospital, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. James' Hospital
City
Dublin
ZIP/Postal Code
D8
Country
Ireland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Deleted post analysis
Citations:
PubMed Identifier
31529194
Citation
Donlon NE, Boland PA, Kelly ME, Schmidt K, Cooke F, Neary PM, Barry KM, Reynolds JV. Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial. Int J Colorectal Dis. 2019 Nov;34(11):2003-2010. doi: 10.1007/s00384-019-03398-9. Epub 2019 Sep 16.
Results Reference
derived
Learn more about this trial
Prophylactic Negative Wound Therapy in Laparotomy Wounds.
We'll reach out to this number within 24 hrs