Prophylactic Negative Wound Therapy in Laparotomy Wounds.
NCT ID: NCT03871023
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2019-11-06
2020-12-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Simple dressing
Standard, waterproof dressing applied to wound
Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome
PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome
PICO Dressing
Negative Wound pressure applied second cohort
PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome
PREVENA Dressing
Negative wound presure applied to third cohort
Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome
Interventions
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Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome
PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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St. James's Hospital, Ireland
OTHER
Responsible Party
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Noel Edward Donlon
Specialist Registrar General Surgery
Principal Investigators
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Noel E Donlon
Role: PRINCIPAL_INVESTIGATOR
St. James's Hospital, Ireland
Locations
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St. James' Hospital
Dublin, , Ireland
Countries
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Central Contacts
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References
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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.
Other Identifiers
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SJH0519
Identifier Type: -
Identifier Source: org_study_id
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