Prophylactic Negative Wound Therapy in Laparotomy Wounds.
- Conditions
- Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
- Interventions
- Device: Smith & Nephew PICO Negative wound pressure versus standard dresingDevice: PREVENA Negative pressure wound versus standard dressing
- Registration Number
- NCT03871023
- Lead Sponsor
- St. James's Hospital, Ireland
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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.
- Pregnant patients and those undergoing re-look laparotomies are to be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simple dressing Smith & Nephew PICO Negative wound pressure versus standard dresing Standard, waterproof dressing applied to wound PICO Dressing PREVENA Negative pressure wound versus standard dressing Negative Wound pressure applied second cohort PREVENA Dressing Smith & Nephew PICO Negative wound pressure versus standard dresing Negative wound presure applied to third cohort Simple dressing PREVENA Negative pressure wound versus standard dressing Standard, waterproof dressing applied to wound
- Primary Outcome Measures
Name Time Method superficial site infection via southampton scoring system (higher score - worse outcome) 5 days seroma/haematoma/abscess formation
Wound Dehisence 5 days disruption of wound continuity
- Secondary Outcome Measures
Name Time Method Wound healing/Cosmesis week 6 post op scar healing (via observer scar assesment scale - higher score wore outcome)
home care therapy 30days lenth of home care dressings
Length of hospital stay 30 days wound complications causing prolonged hospital stay
Trial Locations
- Locations (1)
St. James' Hospital
🇮🇪Dublin, Ireland