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Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation (PTN-INSTILL)

Primary Purpose

Infected Surgical Wound

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
PTNiA
PTNiB
PTN
Sponsored by
Associazione Infermieristica per lo studio delle Lesioni Cutanee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infected Surgical Wound focused on measuring Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Policlinico Sant'Orsola MalpighiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

PTNiA

PTNiB

PTN

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Absence of clinical infection (according NHSN 2014)
frequency of wound without clinical infection
Absence of clinical infection
number of days to absence clinical infection

Secondary Outcome Measures

Treatment days
number of days to wounds treatment
Wound closure
number of days to wounds closure
Patient's discharge
number of days to patient's discharge
Patient's pain (Numeric Rating Scale (NRS)
assessment with Numeric Rating Scale (NRS)

Full Information

First Posted
May 24, 2015
Last Updated
July 15, 2015
Sponsor
Associazione Infermieristica per lo studio delle Lesioni Cutanee
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1. Study Identification

Unique Protocol Identification Number
NCT02500875
Brief Title
Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
Acronym
PTN-INSTILL
Official Title
Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associazione Infermieristica per lo studio delle Lesioni Cutanee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infected Surgical Wound
Keywords
Negative-Pressure Wound Therapy, Topical Negative Pressure Therapy, Sodium Hypochlorite

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTNiA
Arm Type
Experimental
Arm Description
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).
Arm Title
PTNiB
Arm Type
Experimental
Arm Description
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).
Arm Title
PTN
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
PTNiA
Intervention Type
Device
Intervention Name(s)
PTNiB
Intervention Type
Device
Intervention Name(s)
PTN
Primary Outcome Measure Information:
Title
Absence of clinical infection (according NHSN 2014)
Description
frequency of wound without clinical infection
Time Frame
1 month
Title
Absence of clinical infection
Description
number of days to absence clinical infection
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Treatment days
Description
number of days to wounds treatment
Time Frame
1 month
Title
Wound closure
Description
number of days to wounds closure
Time Frame
1 month
Title
Patient's discharge
Description
number of days to patient's discharge
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Title
Patient's pain (Numeric Rating Scale (NRS)
Description
assessment with Numeric Rating Scale (NRS)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Chiari
Email
paolo.chiari@aosp.it
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Peghetti
Email
angela.peghetti@aosp.bo.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Chiari
Organizational Affiliation
Policlinico Sant'Orsola Malpighi Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Chiari
Email
paolo.chiari@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Angela Peghetti
Email
angela.peghetti@aosp.bo.it

12. IPD Sharing Statement

Learn more about this trial

Treatment of Infected Surgical Wounds With Negative Pressure Topical Therapy and Instillation (With or Without Antiseptic) Versus no Instillation

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