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Prophylactic Negative Wound Therapy in Laparotomy Wounds.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03871023
Acronym
PROPEL
Enrollment
240
Registered
2019-03-12
Start date
2019-11-06
Completion date
2020-12-01
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICESmith & Nephew PICO Negative wound pressure versus standard dresing

To investigate if negative wound pressure improves wound outcome

DEVICEPREVENA Negative pressure wound versus standard dressing

To investigate if negative wound pressure improves wound outcome

Sponsors

St. James's Hospital, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

3 separate treatment arms

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
superficial site infection via southampton scoring system (higher score - worse outcome)5 daysseroma/haematoma/abscess formation
Wound Dehisence5 daysdisruption of wound continuity

Secondary

MeasureTime frameDescription
Wound healing/Cosmesisweek 6 post opscar healing (via observer scar assesment scale - higher score wore outcome)
Length of hospital stay30 dayswound complications causing prolonged hospital stay
home care therapy30dayslenth of home care dressings

Countries

Ireland

Contacts

Primary ContactNoel E Donlon
donlonn@tcd.ie00353863557726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026