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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Control group which will cover surgical wound with conventional wound dressing |
|
| PICO | Experimental | Group that will use Pico® device for wound dressing |
|
| PREVENA | Experimental | Group that will use Prevena® device for wound dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incisional negative pressure wound therapy | Device | Application of negative pressure wound therapy for prophylaxis of surgical site occurrences |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site infection | Surgical site infection following emergency laparotomy | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical site occurrences | Seroma, hematoma, wound dehiscence | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | post-operative length of stay | 30 days |
| Reinterventions | 30 days | |
| Adverse events related to devices |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo J Costa, MD | Centro Hospitalar do Tâmega e Sousa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar do Tâmega e Sousa | Penafiel | Porto District | Portugal |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 2, 2024 | |
| Reset | Jun 14, 2024 |
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Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
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| Control group - standard wound dressing | Other | Covering of surgical wound with standard wound dressing |
|
| 30 days |
| Surgical complications | 30 days |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 2, 2024 | Jun 14, 2024 |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D000072836 | Surgical Wound |
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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