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Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05716490
Acronym
OPTIWOUND
Enrollment
114
Registered
2023-02-08
Start date
2022-07-01
Completion date
2023-09-01
Last updated
2023-11-13

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

Conditions

Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication, Surgical Wound Dehiscence, Surgical Wound Haemorrhage, Surgical Wound, Healed

Keywords

iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection

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.

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 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.

Interventions

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

OTHERControl group - standard wound dressing

Covering of surgical wound with standard wound dressing

Sponsors

Centro Hospitalar do Tâmega e Sousa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection30 daysSurgical site infection following emergency laparotomy

Secondary

MeasureTime frameDescription
Surgical site occurrences30 daysSeroma, hematoma, wound dehiscence

Other

MeasureTime frameDescription
Length of stay30 dayspost-operative length of stay
Reinterventions30 days
Adverse events related to devices30 days
Surgical complications30 days

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026