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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-01-31

Brief Summary

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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%.

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Detailed Description

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Conditions

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Infected Surgical Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PTNiA

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).

Group Type EXPERIMENTAL

PTNiA

Intervention Type DEVICE

PTNiB

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).

Group Type EXPERIMENTAL

PTNiB

Intervention Type DEVICE

PTN

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).

Group Type ACTIVE_COMPARATOR

PTN

Intervention Type DEVICE

Interventions

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PTNiA

Intervention Type DEVICE

PTNiB

Intervention Type DEVICE

PTN

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No