Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

Surgical Site Infection Clinical Trial

— OPTIWOUND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716490
• Other study ID #: 29/2022
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2023
• Source: Centro Hospitalar do Tâmega e Sousa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Hemorrhage
• Infections
• Surgical Complication
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Dehiscence
• Surgical Wound Infection
• Surgical Wound, Healed
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Incisional negative pressure wound therapy
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences

Other:
• Control group - standard wound dressing
Covering of surgical wound with standard wound dressing

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Tâmega e Sousa	Penafiel	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Tâmega e Sousa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	post-operative length of stay	30 days
Other	Reinterventions		30 days
Other	Adverse events related to devices		30 days
Other	Surgical complications		30 days
Primary	Surgical site infection	Surgical site infection following emergency laparotomy	30 days
Secondary	Surgical site occurrences	Seroma, hematoma, wound dehiscence	30 days