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

Burns Clinical Trial

Official title:

An Open Non-controlled Post-marketing Investigation Evaluating the Experience of Using a Self- Adherent Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418482
• Other study ID #: MxB Ag 02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 27, 2011
• Last updated: August 16, 2011
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

Description:

At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn.

At each visit the following variables will be collected where applicable:

• Investigator's/Nurse evaluation of

• Overall experience of the dressing

• Ability of dressing to stay in place (not at baseline)

• Conformability of the dressing

• Handling at application

• Ease of removal of the dressing (not at baseline)

• Subject evaluation of

• Overall experience of the dressing

• Comfort of the dressing

• Conformability of the dressing

• Pain before, during and after removal of dressing according to VAS

• Status of skin

• Burn status: width x length, exudate details and signs of inflammation/infection

In addition the following variables should be evaluated at each visit:

• Concomitant medication/treatment

• Adverse Event/Adverse Device Effect (AE/ADE)

• Serious Adverse Event/Serious Adverse Device Effect (sAE/sADE)

Photos will be taken before Mepilex Border Ag is removed, after removal, before cleansing, and after cleansing. All photos must include a sticker marker with subject code, visit number and date, and an indication of whether pre-/post removal, pre-/post cleansing. The stick marker also contains a ruler. Detailed instructions on how to take the photos is given in Appendix 14.2

At each visit the subject will give the assessment concerning the comfort and stay-on-ability of the dressing. The investigator will also give an assessment at each visit concerning handling, conformability and ability of dressing to stay in place.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject with a small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*

2. Male or female, 18 years and above, both in- and out-patient subjects

3. Signed Informed Consent Form

Exclusion Criteria:

1. Wound size equal to or above 9.5x15cm for the selected burn for the investigation

2. Pregnant and/or breastfeeding women

3. Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator

4. Subjects with known sensitivity to silver or any other contents of the dressing

5. Subjects previously included in this investigation

6. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Mepilex Border Ag
Dressing

Locations

Country	Name	City	State
Sweden	Briva/Hpk	Linköping
Sweden	Plastikkirurgiska kliniken, UAS BRIVA	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the experience of using Mepilex Border Ag in normal clinical practice	The primary objective is to evaluate the experience of using Mepilex Border Ag in normal clinical practice when used on small second degree burns (< 9.5x15 cm) in need of topical antimicrobial treatment according to the treating physician, i.e. increasing signs of infection, odour, pain and exudate (none, mild, moderate and severe).	3 weeks	No
Secondary	Evaluate the comfort	Secondary objectives are to evaluate the comfort, conformability, handling at application, ability to stay in place, pain during wear (in-between dressing changes) and at removal of dressing and adverse events according to the subject and treating hospital staff. Scale used is from very poor - very good.	3 weeks	No
Secondary	Pain	To evaluate pain before dressing removal,during dressing removal and after dressing removal measured with John Hopkins pain scale.	3 weeks	No