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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simple dressing | Active Comparator | Standard, waterproof dressing applied to wound |
|
| PICO Dressing | Active Comparator | Negative Wound pressure applied second cohort |
|
| PREVENA Dressing | Active Comparator | Negative wound presure applied to third cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smith & Nephew PICO Negative wound pressure versus standard dresing | Device | To investigate if negative wound pressure improves wound outcome |
|
| Measure | Description | Time Frame |
|---|---|---|
| superficial site infection via southampton scoring system (higher score - worse outcome) | seroma/haematoma/abscess formation | 5 days |
| Wound Dehisence | disruption of wound continuity | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing/Cosmesis | scar healing (via observer scar assesment scale - higher score wore outcome) | week 6 post op |
| Length of hospital stay | wound complications causing prolonged hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noel E Donlon | Contact | 00353863557726 | 00353863557726 | donlonn@tcd.ie |
| Name | Affiliation | Role |
|---|---|---|
| Noel E Donlon | St. James's Hospital, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. James' Hospital | Dublin | D8 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31529194 | Derived | 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. |
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Deleted post analysis
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D007239 | Infections |
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3 separate treatment arms
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| PREVENA Negative pressure wound versus standard dressing | Device | To investigate if negative wound pressure improves wound outcome |
|
| 30 days |
| home care therapy | lenth of home care dressings | 30days |