Prophylactic Negative Wound Therapy in Laparotomy Wounds.

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

— PROPEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03871023
• Other study ID #: SJH0519
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: St. James's Hospital, Ireland
• Contact: Noel E Donlon
• Phone: 00353863557726
• Email: donlonn[@]tcd.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Smith & Nephew PICO Negative wound pressure versus standard dresing
To investigate if negative wound pressure improves wound outcome
• PREVENA Negative pressure wound versus standard dressing
To investigate if negative wound pressure improves wound outcome

Locations

Country	Name	City	State
Ireland	St. James' Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	superficial site infection via southampton scoring system (higher score - worse outcome)	seroma/haematoma/abscess formation	5 days
Primary	Wound Dehisence	disruption of wound continuity	5 days
Secondary	Wound healing/Cosmesis	scar healing (via observer scar assesment scale - higher score wore outcome)	week 6 post op
Secondary	Length of hospital stay	wound complications causing prolonged hospital stay	30 days
Secondary	home care therapy	lenth of home care dressings	30days