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

Phase 3

• Conditions: Infected Surgical Wound

• Registration Number: NCT02500875
• Lead Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-05
• Study First Submitted: 2015-05-24
• Study First Submitted QC: 2015-07-15
• Last Update Submitted: 2015-07-15
• Study First Posted: 2015-07-17
• Last Update Posted: 2015-07-17
• Primary Completion: 2015-11
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Absence of clinical infection (according NHSN 2014)	1 month	frequency of wound without clinical infection
Absence of clinical infection	1 month	number of days to absence clinical infection

Secondary Outcome Measures

Name	Time	Method
Patient's pain (Numeric Rating Scale (NRS)	1 month	assessment with Numeric Rating Scale (NRS)
Treatment days	1 month	number of days to wounds treatment
Wound closure	1 month	number of days to wounds closure
Patient's discharge	participants will be followed for the duration of hospital stay, an expected average of 5 weeks	number of days to patient's discharge

Trial Locations

Locations (1)

Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy