NCT03871023

Prophylactic Negative Wound Therapy in Laparotomy Wounds.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: St. James's Hospital, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-06
• Primary completion: 2020-05-01
• Completion: 2020-12-01
• First posted: 2019-03-12
• Last updated: 2019-09-18

Locations

1 site across 1 country: Ireland