Prophylactic Negative Wound Therapy in Laparotomy Wounds.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds

Conditions
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Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay

Intervention / Treatment
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* Device: Smith & Nephew PICO Negative wound pressure versus standard dresing
* Device: PREVENA Negative pressure wound versus standard dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 separate treatment arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simple dressing<br>Standard, waterproof dressing applied to wound | Device: Smith & Nephew PICO Negative wound pressure versus standard dresing<br>* To investigate if negative wound pressure improves wound outcome<br>Device: PREVENA Negative pressure wound versus standard dressing<br>* To investigate if negative wound pressure improves wound outcome<br>|
| Active Comparator: PICO Dressing<br>Negative Wound pressure applied second cohort | Device: PREVENA Negative pressure wound versus standard dressing<br>* To investigate if negative wound pressure improves wound outcome<br>|
| Active Comparator: PREVENA Dressing<br>Negative wound presure applied to third cohort | Device: Smith & Nephew PICO Negative wound pressure versus standard dresing<br>* To investigate if negative wound pressure improves wound outcome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30 days | 
| home care therapy | lenth of home care dressings | 30days |