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OpenTrials
Completed

NCT Number: NCT05716490

Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar do Tâmega e Sousa

Penafiel, Porto District, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incisional negative pressure wound therapy

Device

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

Control group - standard wound dressing

Other

Covering of surgical wound with standard wound dressing

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days

    Surgical site infection following emergency laparotomy

Secondary outcomes

  1. Surgical site occurrences

    Time frame: 30 days

    Seroma, hematoma, wound dehiscence

Other outcomes

  1. Length of stay

    Time frame: 30 days

    post-operative length of stay

  2. Reinterventions

    Time frame: 30 days

  3. Adverse events related to devices

    Time frame: 30 days

  4. Surgical complications

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Tâmega e Sousa

Other

Registry information

Official study title

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

Acronym: OPTIWOUND

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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