Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy (OPTIWOUND)

Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Wound; Surgical Wound Infection; Surgical Site Infection; Surgical Wound, Healed; Surgical Complication; Surgical Wound Dehiscence; Surgical Wound Haemorrhage
• Intervention / Treatment: Other: Control group - standard wound dressing; Device: Incisional negative pressure wound therapy

Detailed Description

A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.

Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.

Later where excluded from the study patients with class IV Center for disease control wound type, patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).

Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith & Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.

Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.

A final consultation was made 30 days postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcelo J Costa, MD; Phone Number: +351 919083598; Email: marcelojcosta02@gmail.com
• Study Contact Backup: Name: Marta MM Martins, MD; Email: martamartins017@gmail.com

Study Locations

• Portugal
  • Porto
    • Penafiel, Porto, Portugal
      • Centro Hospitalar do Tâmega e Sousa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All patients proposed for emergency laparotomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard; Control group which will cover surgical wound with conventional wound dressing	Other: Control group - standard wound dressing; Covering of surgical wound with standard wound dressing
Experimental: PICO; Group that will use Pico® device for wound dressing	Device: Incisional negative pressure wound therapy; Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Experimental: PREVENA; Group that will use Prevena® device for wound dressing	Device: Incisional negative pressure wound therapy; Application of negative pressure wound therapy for prophylaxis of surgical site occurrences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Surgical site infection following emergency laparotomy	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site occurrences	Seroma, hematoma, wound dehiscence	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications		30 days
Length of stay	post-operative length of stay	30 days
Reinterventions		30 days
Adverse events related to devices		30 days

Collaborators and Investigators

• Sponsor: Centro Hospitalar do Tâmega e Sousa
• Investigators: Principal Investigator: Marcelo J Costa, MD, Centro Hospitalar do Tâmega e Sousa

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: surgical site infection; general surgery; emergency laparotomy; iNPWT; Incision negative pressure wound therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Emergencies; Infections; Communicable Diseases; Wounds and Injuries; Hemorrhage; Surgical Wound; Surgical Wound Infection; Wound Infection; Surgical Wound Dehiscence
• Other Study ID Numbers: 29/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No