Comparing a Synergistic Antimicrobial Cleanser & Gel to Normal Saline & an

Status Active, not recruiting

Clinical Trial Summary

The study is a randomized double-blind controlled clinical trial designed to compare healing rates between normal saline wash in combination with an amorphous gel (NSS-HG) versus the grouping of a synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG) in chronic lower extremity ulcers. After consenting, the ulcers of eligible subjects are measured, photographed and undergo the MolecuLight imaging procedure (MiX). The subject is then randomized to one of two arms: target ulcer cleansed saline wash and an amorphous gel (NSS-HG) or synergistic antimicrobial cleanser (AMC) and antimicrobial gel (AMG). After cleansing the wound a second MiX is performed. The subject is given a four-week supply.

Clinical Trial Description

BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound, or application site. BIAKOS™ Antimicrobial Skin and Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus [MRSA). and fungus Candida albicans within the product. BIAKŌS Antimicrobial Wound Gel provides a moist environment to wound surfaces. BIAKŌS Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. BIAKŌS Antimicrobial Wound Gel: • Resists microbial colonization within the gel during shelf storage. • Provides an amorphous gel covering. • Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement in which the body's own enzymes breakdown necrotic tissue. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05107050
Study type	Interventional
Source	SerenaGroup, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 1, 2021
Completion date	May 25, 2023

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT03872544` - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Active, not recruiting	`NCT03649308` - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting	N/A
Active, not recruiting	`NCT03796988` - Autologous Regeneration of Tissue (ART) for Wound Healing	N/A
Enrolling by invitation	`NCT03880188` - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting	`NCT05588583` - A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.	N/A
Suspended	`NCT01301118` - Graft Take and Microbiology in Burns	N/A
Completed	`NCT05618912` - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment	N/A
Completed	`NCT03938584` - The Effect of Vitamin C on Wound Healing In Mandibular Fracture Patients	N/A
Not yet recruiting	`NCT05324514` - Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System	N/A
Recruiting	`NCT05608317` - A Clinical Investigation to Follow the Progress of Exuding Chronic Venous Leg Ulcers Using a Non-Bordered Foam Dressing	N/A
Recruiting	`NCT05844527` - Safety and Efficacy of MRG-001 in Wound Healing in Abdominoplasty Patients	Phase 2
Completed	`NCT04771819` - Safety and Performance of SWIS in Superficial Wounds	N/A
Active, not recruiting	`NCT05263713` - Aesthetic Outcome of Running Subcuticular Suture Versus Running Horizontal Mattress Suture Closure of Linear Wounds on the Trunk and Extremities	N/A
Recruiting	`NCT05741866` - Novel Antimicrobial Dressing in Peripheral Intravenous Catheters (PIVCs)	N/A
Completed	`NCT01348841` - Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial	N/A
Recruiting	`NCT05217160` - Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers	Phase 4
Recruiting	`NCT03346694` - Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing	N/A
Completed	`NCT03481907` - Topical Collagen Powder for Healing of Acute Full-thickness Wounds	N/A
Completed	`NCT01658163` - Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh	N/A
Recruiting	`NCT06178289` - Effectiveness of 3M Cavilon Advanced Skin Protectant in the Treatment of Moisture-associated Skindamage in Nursinghomes	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparing a Synergistic Antimicrobial Cleanser and Gel to Normal Saline and an Amorphous Gel in Reducing Bioburden and Promoting Healing in Chronic Lower Extremity Ulcers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms