Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone (WASH)

Universidad Tecnológica de Pereira

Status and phase: Unknown; Phase 2

Conditions: Surgical Site Infection

Treatments: Drug: Hypochlorous acid; Drug: Iodopovidone

Study type: Interventional

Funder types: Other

Identifiers

NCT00692757

5-07-9

Details and patient eligibility

About

The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

Full description

A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans.

To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.

Enrollment: 432 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients over 18 years old, who are going to be operated
• Classification of surgical wounds according to the National Research Council as class I or II
• Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2

Exclusion criteria

• Patients requiring mesh or prosthesis or orthesis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

432 participants in 2 patient groups

A

Experimental group

Description:

Hypochlorous acid

Treatment:

Drug: Hypochlorous acid

B

Active Comparator group

Description:

Iodopovidone

Treatment:

Drug: Iodopovidone