Clinical trial NCT03871023: Prophylactic Negative Wound Therapy in Laparotomy Wounds.
Official title: The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 separate treatment arms
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: superficial site infection via southampton scoring system (higher score - worse outcome)
timeFrame: 5 days
measure: Wound Dehisence
timeFrame: 5 days
Secondary outcomes:
measure: Wound healing/Cosmesis
timeFrame: week 6 post op
measure: Length of hospital stay
timeFrame: 30 days
measure: home care therapy
timeFrame: 30days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James' Hospital
Study officials:
affiliation: St. James's Hospital, Ireland
name: Noel E Donlon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.