Wound HealingPhase 2NCT02892435
Prevena™ Incision Management System vs Conventional Management for Wound Healing
A Phase 2 study testing incisional negative pressure wound therapy and conventional dressing in people with Wound Healing and Prevena, run by Ospedale Misericordia e Dolce at 1 site in Italy.
Trial summary
Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Healing, Prevena, Dirty Abdominal Surgery
- What is being tested?
- incisional negative pressure wound therapy and conventional dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abdominal surgery
- open surgery
- contaminated or dirty surgery
Who cannot join
- not abdominal surgery
- mininvasive surgery
- clean surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Misericordia e Dolce Hospital
Prato, Po, 59100
Francesco Feroci, MD, +393398382381, fferoci@yahoo.it
Luca Romoli, MD
About this study
Official title: Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management
Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.
Read the 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.
- Conditions
- Wound Healing, Prevena, Dirty Abdominal Surgery, Contaminated Abdominal Surgery, Emergency Abdominal Surgery, Negative-Pressure Wound Therapy
- Being tested
- incisional negative pressure wound therapy, conventional dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incisional negative pressure wound therapyDevice
Also called Prevena - KCI
positioning incisional negative pressure therapy over closed wound.
conventional dressingDevice
positioning conventional dressing
| Study group | Role | What they receive |
|---|---|---|
| Prevena arm | Experimental | patients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days Receives: Device: incisional negative pressure wound therapy |
| Control arm | Active comparator | patients underwent to contaminated/dirty surgery who positioned conventional dressing Receives: Device: conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection (SSI) reduction
quantify SSI decrease after incisional negative pressure wound therapy
Measured: 7 months
Secondary outcomes (1)
Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer
check connection between wound complications and risk factors and showing if Incisional Negative Pressure Wound Therapy (INPWT) could reduce effects of these risk factors
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Misericordia e Dolce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Scatizzi, Ospedale Misericordia e Dolce
- Investigators
- Francesco Feroci, MD, Principal investigator, Ospedale Santo Stefano Prato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892435
- Sponsor's protocol ID
- 012/2015
- Status last verified
- Sep 2016
- First submitted
- 19 May 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing After Dirty/Contaminated Emergency Abdominal Surgery: Prevena™ Incision Management System vs Conventional Management
- ClinicalTrials.gov ID
- NCT02892435
- Acronym / sponsor ID
- 012/2015
- Conditions
- Wound Healing, Prevena, Dirty Abdominal Surgery, Contaminated Abdominal Surgery, Emergency Abdominal Surgery, Negative-Pressure Wound Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ospedale Misericordia e DolceUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevena arm | Experimental | Device: incisional negative pressure wound therapypatients underwent to contaminated/dirty surgery who positioned incisional negative pressure wound therapy and kept for six days |
| Control arm | Active comparator | Device: conventional dressingpatients underwent to contaminated/dirty surgery who positioned conventional dressing |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- abdominal surgery
- open surgery
- contaminated or dirty surgery
Key exclusion criteria (3 listed)
- not abdominal surgery
- mininvasive surgery
- clean surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incisional negative pressure wound therapyAlso: Prevena - KCIpositioning incisional negative pressure therapy over closed wound. | Device | Prevena arm |
| conventional dressingpositioning conventional dressing | Device | Control arm |
Primary outcome
Surgical Site Infection (SSI) reduction
Time frame: 7 months
quantify SSI decrease after incisional negative pressure wound therapy
1 secondary outcome
Surgical Site Infection (SSI) and risk factors as diabetis, obesity and cancer
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Feroci, MD principal investigator
Ospedale Santo Stefano Prato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing incisional negative pressure wound therapy and conventional dressing in people with Wound Healing and Prevena, run by Ospedale Misericordia e Dolce at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessia Garzi, MD (0574804612 ext. +39, alessia.garzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (SSI) reduction (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.