---
title: Prevena™ Incision Management System vs Conventional Management for Wound Healing
nct_id: NCT02892435
overall_status: UNKNOWN
phase: PHASE2
sponsor: Ospedale Misericordia e Dolce
study_type: INTERVENTIONAL
primary_condition: Wound Healing
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02892435.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02892435"
ct_last_update_post_date: 2016-09-08
last_seen_at: "2026-05-12T06:00:21.180Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Prevena™ Incision Management System vs Conventional Management for Wound Healing

**Official Title:** Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management

**NCT ID:** [NCT02892435](https://clinicaltrials.gov/study/NCT02892435)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Ospedale Misericordia e Dolce
- **Conditions:** Wound Healing, Prevena, Dirty Abdominal Surgery, Contaminated Abdominal Surgery, Emergency Abdominal Surgery, Negative-Pressure Wound Therapy
- **Start Date:** 2014-11
- **Completion Date:** 2017-12
- **CT.gov Last Update:** 2016-09-08

## Brief Summary

Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

## Detailed Description

All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing.

In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score.

Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 90 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* abdominal surgery
* open surgery
* contaminated or dirty surgery

Exclusion Criteria:

* not abdominal surgery
* mininvasive surgery
* clean surgery
```

## Arms

- **Prevena arm** (EXPERIMENTAL) — patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days
- **Control arm** (ACTIVE_COMPARATOR) — patients underwent to contaminated/dirty surgery who positioned conventional dressing

## Interventions

- **incisional negative pressure wound therapy** (DEVICE) — positioning incisional negative pressure therapy over closed wound.
- **conventional dressing** (DEVICE) — positioning conventional dressing

## Primary Outcomes

- **Surgical Site Infection (SSI) reduction** _(time frame: 7 months)_ — quantify SSI decrease after incisional negative pressure wound therapy

## Secondary Outcomes

- **Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer** _(time frame: 2 years)_

## Locations (1)

- Misericordia e Dolce Hospital, Prato, Po, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.misericordia e dolce hospital|prato|po|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02892435.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02892435*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*