Comparison of Chitosan and Carboxymethylcellulose Silver Dressings on Burn Wounds in Pediatric and Adult Subjects

Bandages Clinical Trial

Official title:

A Multi-Center, Randomized, Comparison Study of a Chitosan (Opticell Ag+) Silver Dressing and a Sodium Carboxymethylcellulose (Aquacel® Ag+) Silver Dressing on Burn Wounds in Pediatrics and Adults Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02353507
• Other study ID #: R14-054
• Status: Withdrawn
• Phase: Phase 4
• First received: January 28, 2015
• Last updated: April 25, 2016
• Start date: February 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2015
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective, randomized, comparative multi-center study is to compare the effective management of two silver-based dressings in managing exudative wounds in first and second degree burns.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Inpatient status at the site

• Written consent obtained from the subject

• Burn injury must have been incurred within 36 hours prior to enrollment.

• Burn injury must be of superficial partial thickness, mid-dermal partial thickness, or a combination of the two depths

• Burn injury must exceed 3% total body surface area.

Exclusion Criteria:

• Subject is pregnant.

• Bone fractures.

• Inhalation-related trauma.

• Sensitive and/or allergic to materials containing silver.

• Burn injury exceeds 40% total body surface area.

• Burn injury diagnosis indicates deep partial or full thickness wounds.

• Burn a result of electrical/chemical injury or frostbite.

• An active agent, such as a topical antimicrobial or an enzymatic debriding agent was previously used to treat the burn injury in question.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bandages

Intervention

Device:
• Opticell Ag+

• Aquacel Ag+

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Infection Rates		Up to 21 days of use	Yes
Primary	Days required for wound healing		Up to 21 days of use	No
Secondary	Pain Levels during Dressing Removal	Categorical scale of pain reported by Subject	Up to 21 days	No