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Prophylactic Negative Wound Therapy in Laparotomy Wounds. (PROPEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03871023
Recruitment Status : Unknown
Verified September 2019 by Noel Edward Donlon, St. James's Hospital, Ireland.
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Noel Edward Donlon, St. James's Hospital, Ireland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay Device: Smith & Nephew PICO Negative wound pressure versus standard dresing Device: PREVENA Negative pressure wound versus standard dressing Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 separate treatment arms
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Estimated Study Start Date : November 6, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Simple dressing
Standard, waterproof dressing applied to wound
 Device: Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome

Device: PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome
Active Comparator: PICO Dressing
Negative Wound pressure applied second cohort
 Device: PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome
Active Comparator: PREVENA Dressing
Negative wound presure applied to third cohort
 Device: Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome


Outcome Measures
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Primary Outcome Measures :
  1. superficial site infection via southampton scoring system (higher score - worse outcome) [ Time Frame: 5 days ]
    seroma/haematoma/abscess formation

  2. Wound Dehisence [ Time Frame: 5 days ]
    disruption of wound continuity


Secondary Outcome Measures :
  1. Wound healing/Cosmesis [ Time Frame: week 6 post op ]
    scar healing (via observer scar assesment scale - higher score wore outcome)

  2. Length of hospital stay [ Time Frame: 30 days ]
    wound complications causing prolonged hospital stay

  3. home care therapy [ Time Frame: 30days ]
    lenth of home care dressings


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871023


Contacts
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Contact: Noel E Donlon 00353863557726 ext 00353863557726 donlonn@tcd.ie

Locations
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Ireland
St. James' Hospital
Dublin, Ireland, D8
Sponsors and Collaborators
St. James's Hospital, Ireland
Investigators
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Principal Investigator: Noel E Donlon St. James's Hospital, Ireland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Noel Edward Donlon, Specialist Registrar General Surgery, St. James's Hospital, Ireland
ClinicalTrials.gov Identifier: NCT03871023    
Other Study ID Numbers: SJH0519
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Deleted post analysis

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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
Additional relevant MeSH terms:
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Wound Infection
Wounds and Injuries
Infections