Infected Surgical WoundPhase 3PTN-INSTILLNCT02500875
Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
A Phase 3 study testing PTNiA, PTNiB and PTN in people with Infected Surgical Wound, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 1 site in Italy.
Trial summary
The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infected Surgical Wound
- What is being tested?
- PTNiA, PTNiB and PTN
- 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
- Jan 2015to Jan 2016
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with infected surgical wounds.
- Patient age greater than or equal to 18 years.
- Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.
Who cannot join
- Patients unable of consent.
- Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.
- Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.
- Patients with malignancy at the wound.
- Patients with untreated osteomyelitis.
- Patients with enteric and unexplored fistulas.
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- Patients with necrotic tissue and eschar.
- Immunocompromised patients or in treatment with corticosteroids.
- Suspected or known allergic diathesis to the product of medication.
- Patients with coagulation disease.
Trial locations and contacts
1 site in 1 country.
Paolo Chiari contact
Angela Peghetti contact
Italy1 site, 1 recruiting
- Recruiting
Policlinico Sant'Orsola Malpighi
Bologna, Bologna, 40138
Paolo Chiari, paolo.chiari@aosp.bo.it
Angela Peghetti, angela.peghetti@aosp.bo.it
About this study
The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.
- Conditions
- Infected Surgical Wound
- Being tested
- PTNiA, PTNiB, PTN
- Keywords
- Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNiADevice
PTNiBDevice
PTNDevice
| Study group | Role | What they receive |
|---|---|---|
| PTNiA | Experimental | Topical negative pressure therapy with instillation of saline solution (6 times daily).
During the instillation of saline solution, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). Receives: Device: PTNiA |
| PTNiB | Experimental | Topical negative pressure therapy with instillation of Amukine Med 0,05% (6 times daily).
During the instillation of Amukine Med 0,05%, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). Receives: Device: PTNiB |
| PTN | Active comparator | Topical negative pressure therapy (without instillation). The device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg.
The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). Receives: Device: PTN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of clinical infection (according NHSN 2014)
frequency of wound without clinical infection
Measured: 1 month
Absence of clinical infection
number of days to absence clinical infection
Measured: 1 month
Secondary outcomes (4)
Treatment days
number of days to wounds treatment
Measured: 1 month
Wound closure
number of days to wounds closure
Measured: 1 month
Patient's discharge
number of days to patient's discharge
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Patient's pain (Numeric Rating Scale (NRS)
assessment with Numeric Rating Scale (NRS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infected Surgical WoundStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni Cutanee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabrielli Barbara, Associazione Infermieristica per lo studio delle Lesioni Cutanee
- Investigators
- Paolo Chiari, Principal investigator, Policlinico Sant'Orsola Malpighi Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500875
- Sponsor's protocol ID
- AISLeC-004
- Acronym
- PTN-INSTILL
- Status last verified
- May 2015
- First submitted
- 24 May 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
- ClinicalTrials.gov ID
- NCT02500875
- Acronym / sponsor ID
- PTN-INSTILL / AISLeC-004
- Conditions
- Infected Surgical Wound
- Keywords
- Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni CutaneeUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 17 Jul 2015 (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.
The objective of this study is to evaluate the effectiveness of PTNi therapy versus PTN therapy without instillation in the treatment of infected surgical wounds. Investigators mean to verify differences of effectiveness between the different types of instilled substances, normal saline versus Amukine Med 0.5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PTNiA | Experimental | Device: PTNiATopical negative pressure therapy with instillation of saline solution (6 times daily). During the instillation of saline solution, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
| PTNiB | Experimental | Device: PTNiBTopical negative pressure therapy with instillation of Amukine Med 0,05% (6 times daily). During the instillation of Amukine Med 0,05%, aspiration is stopped for 10-15 minutes and subsequently the device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
| PTN | Active comparator | Device: PTNTopical negative pressure therapy (without instillation). The device is programmed to exert a sub atmospheric pressure in aspiration of at least 50 mmHg up to a maximum of 200 mmHg. The change of dressing is carried out on the first day after the application of the device, and thereafter, as needed (approximately every 3 or 4 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with infected surgical wounds.
- Patient age greater than or equal to 18 years.
- Patients who have given informed consent to the enrollment in the trial and to the processing of personal data.
Key exclusion criteria (10 listed)
- Patients unable of consent.
- Patients affected by serious medical conditions that, according to the investigator's opinion, represent a contraindication to the study participation.
- Patients affected by wounds with exposition of blood vessels, sutures, organs or nerves and open wounds in mediastinum or abdomen.
- Patients with malignancy at the wound.
- Patients with untreated osteomyelitis.
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 |
|---|---|---|
| PTNiA | Device | PTNiA |
| PTNiB | Device | PTNiB |
| PTN | Device | PTN |
Primary outcome
Absence of clinical infection (according NHSN 2014)
Time frame: 1 month
frequency of wound without clinical infection
Absence of clinical infection
Time frame: 1 month
number of days to absence clinical infection
4 secondary outcomes
Treatment days
Time frame: 1 month
Wound closure
Time frame: 1 month
Patient's discharge
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Patient's pain (Numeric Rating Scale (NRS)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Paolo Chiari contact
Angela Peghetti contact
Paolo Chiari principal investigator
Policlinico Sant'Orsola Malpighi Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PTNiA, PTNiB and PTN in people with Infected Surgical Wound, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee 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 10 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 17 Jul 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Paolo Chiari (paolo.chiari@aosp.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of clinical infection (according NHSN 2014) (time frame: 1 month). The study lists 2 primary outcomes in all. 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 17 Jul 2015.