NCT05716490

Brief Summary

The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

January 28, 2023

Last Update Submit

November 9, 2023

Conditions

Surgical Site InfectionSurgical WoundSurgical Wound InfectionSurgical ComplicationSurgical Wound DehiscenceSurgical Wound HaemorrhageSurgical Wound, Healed

Keywords

iNPWTIncision negative pressure wound therapyemergency laparotomygeneral surgerysurgical site infection

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    Surgical site infection following emergency laparotomy

    30 days

Secondary Outcomes (1)

  • Surgical site occurrences

    30 days

Other Outcomes (4)

  • Length of stay

    30 days

  • Reinterventions

    30 days

  • Adverse events related to devices

    30 days

  • +1 more other outcomes

Study Arms (3)

Standard

ACTIVE COMPARATOR

Control group which will cover surgical wound with conventional wound dressing

Other: Control group - standard wound dressing

PICO

EXPERIMENTAL

Group that will use Pico® device for wound dressing

Device: Incisional negative pressure wound therapy

PREVENA

EXPERIMENTAL

Group that will use Prevena® device for wound dressing

Device: Incisional negative pressure wound therapy

Interventions

Incisional negative pressure wound therapyDEVICE

Application of negative pressure wound therapy for prophylaxis of surgical site occurrences

PICOPREVENA
Control group - standard wound dressingOTHER

Covering of surgical wound with standard wound dressing

Standard

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients proposed for emergency laparotomy

You may not qualify if:

  • Contra-indication for iNPWT
  • Irreversible disease diagnosis with expected short term mortality
  • Need for a staged procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar do Tâmega e Sousa

Penafiel, Porto District, Portugal

Location

MeSH Terms

Conditions

Surgical Wound InfectionSurgical WoundSurgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Marcelo J Costa, MD

    Centro Hospitalar do Tâmega e Sousa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, general surgery resident

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

July 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)