Centro Hospitalar do Tâmega e Sousa
Penafiel, Porto District, Portugal
NCT Number: NCT05716490
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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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Penafiel, Porto District, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Covering of surgical wound with standard wound dressing
Time frame: 30 days
Surgical site infection following emergency laparotomy
Time frame: 30 days
Seroma, hematoma, wound dehiscence
Time frame: 30 days
post-operative length of stay
Time frame: 30 days
Time frame: 30 days
Time frame: 30 days
Centro Hospitalar do Tâmega e Sousa
Other
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
Acronym: OPTIWOUND
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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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