Prophylactic Negative Wound Therapy in Laparotomy Wounds. (PROPEL)

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

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.

Study Overview

• Status: Unknown
• Conditions: Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
• Intervention / Treatment: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing; Device: PREVENA Negative pressure wound versus standard dressing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D8
    • St. James' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. James's Hospital, Ireland
• Investigators: Principal Investigator: Noel E Donlon, St. James's Hospital, Ireland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 6, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: SJH0519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deleted post analysis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes