Efficacy of Prontosan Solution on Chronic Ulcers

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

NCT01048307

Wound Care Venous Ulcer Care Wound Cleansing +1 more

COMPLETED NA

Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)

NCT03369756

Wound of Lower Leg (Physical Finding)

TERMINATED NA

Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel

NCT01153633

Venous Leg Ulcer

COMPLETED PHASE4

Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

NCT01554644

Diabetic Complications

WITHDRAWN NA

Effectiveness and Safety of Using Prontosan to Treat Bacterial Biofilm

NCT06185465

Irrigation Solution Chronic Wound Pressure Injury +2 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcer Chronic Wound Care Wound Cleansing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prontosan wound irrigation solution

Group Type EXPERIMENTAL

Prontosan wound irrigation solution

Intervention Type DEVICE

* cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G)
* positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes
* dressing with Prontosan Wound Irrigation solution

Standard care

Group Type ACTIVE_COMPARATOR

Isotonic solution (saline or lactated ringer)

Intervention Type DRUG

* cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G)
* positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes
* dressing with isotonic solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prontosan wound irrigation solution

* cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G)
* positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes
* dressing with Prontosan Wound Irrigation solution

Intervention Type DEVICE

Isotonic solution (saline or lactated ringer)

* cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G)
* positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes
* dressing with isotonic solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
* Braden index at baseline\>=10
* Ulcer area\<80 cm2
* Ability to give an informed consent

Exclusion Criteria

* Braden index at baseline\<10
* Current therapy with corticosteroids or immunosuppressor or radiotherapy
* Sensitivity to any of the components of Prontosan® Solution
* Diabetic foot ulcer
* Current use of local antiseptics on the wound bed
* Previous recruitment of another ulcer in the trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No