Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hematoma
- Length of Stay
- Seroma
- Surgical Site Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Study Type: Interventional (Clinical Trial) Estimated Enrollment: 334 Allocation: Randomized control trial Intervention Model: Parallel Assignment Intervention Model Description: 2 separate treatment arms Primary Purpose: Prevention Official Title: Standard wound dressing versus prophylactic negative-pressure wound therapy after emergency laparotomy Estimated Study Start Date: 09.2020 Estimated Primary Completion Date:09.2021 Estimated Study Completion Date: 09.2025 Masking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias. Despite standard surgical aseptically technique and perioperative prevention management of infections...
Emergency laparotomies lead to increased morbidity and mortality rates. In this scenario the most frequent wound occurrences are represented by wound infections, skin dehiscence or parietal hernias. Despite standard surgical aseptically technique and perioperative prevention management of infections (e.g. antibiotics), wound complications after emergency laparotomies are still an important unmet challenge. Moreover, all these complications increase the cost of care requiring new managements. CINPt has been longly used to favour the successful healing of a plethora of open wounds. In particular CINPt is based on the application of local negative pressure to the wound surface. In case of open abdomens, the procedure is performed by applying a sterile abdominal dressing, which consists of a fenestrated soft plastic non-adherent layer with enclosed central foam, which is placed on the surface of the viscera. Then, two layers of porous sponge dressings are applied over the plastic layer. Finally, a transparent adhesive is placed over the foam and the wound to seal the abdominal cavity. The entire system is then connected, by suction tubes, to a device which ubiquitously applies negative pressure (cyclically or continuously) on the surface. The fluid from the wound is collected into a container. The benefits of negative pressure wound therapy have been reported to include removal of infectious material, reduction in oedema and improved perfusion to tissue. Since few years, a new negative pressure wound therapy has been created for closed wounds to reduce time of healing and avoid wound complications.
Tracking Information
- NCT #
- NCT04496180
- Collaborators
- Meyer Jeremy. PhD. Co-investigator. University Hospital, Geneva.
- Peloso Andrea. PhD. Co-investigator. University Hospital, Geneva.
- Ris Frederic. P.D. Clinical Professor. University Hospital, Geneva.
- Toso Christian. PhD. Head of visceral surgery. University Hospital, Geneva.
- Buchs C. Nicolas. P.D. Director of the project. University Hospital, Geneva.
- Investigators
- Not Provided
Get Well Soon