Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

NCT01418482 | Completed Results

• 1 other identifier: MxB Ag 02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice

  burns healed

  3 weeks

Secondary Outcomes (2)

• Evaluate the Comfort

  3 weeks

• Pain

  3 weeks

Study Arms (1)

Mepilex Border Ag

EXPERIMENTAL

Mepilex Border Ag, a silver dressing will be used

Device: Mepilex Border Ag

Interventions

Mepilex Border Ag DEVICE

a silver dressing

Mepilex Border Ag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with a small partial thickness burn (\< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator\*
• Male or female, 18 years and above, both in- and out-patient subjects
• Signed Informed Consent Form

You may not qualify if:

• Wound size equal to or above 9.5x15cm for the selected burn for the investigation
• Pregnant and/or breastfeeding women
• Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
• Subjects with known sensitivity to silver or any other contents of the dressing
• Subjects previously included in this investigation
• Subjects included in other ongoing clinical investigation at present or during the past 30 days

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Briva/Hpk

Linköping, Sweden

Location

Plastikkirurgiska kliniken, UAS BRIVA

Uppsala, Sweden

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Fredrik Huss
• Organization: Uppsala Akademiska Hospital, Dept. of Plastic Surgery

Fredrik.Huss@surgsci.uu.se

+46 771 405 405

Study Officials

• Fredrik Huss, MD

  Akademiska Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: August 17, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 5, 2017
• Results First Posted: May 3, 2017

Record last verified: 2011-08

Locations

SE (2)