Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.

Burn Injuries Clinical Trial

Official title:

An Open, Randomized, Comparative, Multi-centre Investigation Evaluating the Efficacy and Tolerance of Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439074
• Other study ID #: PUMA 418
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: November 10, 2017
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.

Description:

Subjects enrolled in this investigation were in-patients at eleven centers in China. To be included, subjects had to have deep partial-thickness burn injuries. The subjects were consecutively allocated to a subject code providing they fulfilled all inclusion criteria and none of the exclusion criteria and had signed a written informed consent form. Two evaluators independent of each other made the judgment regarding depth of the burn before enrolling a subject. The subjects were randomized to either receive Mepilex Ag or SSD.

Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the investigation products were performed according to a standardized schedule, unless the wound healed before.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects with a deep partial-thickness burn injury covering 2.5%-25% TBSA (3rd degree areas not to exceed 10% TBSA)

• Burn of thermal origin

• Both gender with an age =5 years and =65 years at ICF

• Understood and signed informed consent

• Subjects who are younger than the legal consenting age must have a legally authorized representative

One study burn should be chosen which fulfil the following criteria;

1. isolated burn area (not head and/or face)

2. 2nd degree deep partial

3. area is from 1 to 10% BSA

All deep 2nd degree burn should be treated with the investigation product, Mepilex Ag/SSD (according to the randomization).

Exclusion Criteria:

• Burns "occurred" equal to or older than 36 hours

• Burns of chemical and electrical origin

• Clinically infected burn (as judged by the investigator)

• Subjects with lung injury or subjects being on a ventilator

• Treatment of the burn with an active agent before study entry. SSD is allowed up to 24 hours prior to randomization

• Subjects with dermatologic skin disorders or necrotizing processes

• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment

• Subjects with insulin dependent diabetes mellitus

• Subjects treated with systemic glucocorticosteroids, except Subjects taking occasional doses or doses less than 10mg prednisolon (day or equivalent

• Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days

• Known allergy/hypersensitivity to any of the components (SSD , Ag glycerin, monostearate, glycerol, cetearyl alcohol, leveling agent O, albolene, light liquid paraffin, ethylparaben/ silicone, polyurethane foam pad containing a silver compound, activated carbon)of the investigation products

• Subjects with physical and/or mental conditions that are not expected to comply with the investigation

• Participation in other clinical investigation(s) within 1 month prior to start of the investigation

• Pregnancy (pregnancy test needed if they do not use contraceptive)

• Previously randomized to this investigation (PUMA 418

Related Conditions & MeSH terms

• Burn Injuries
• Burns
• Wounds and Injuries

Intervention

Device:
• Mepilex Ag
Dressing

Drug:
• Silver Sulphadiazine Ag cream
A cream used on burnt areas.

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing
China	The 1st People's Hospital of Foshan	Guangdong	Guangdong
China	Guangzhou red Cross Hospital	Guangzhou	Guangdong
China	The 2nd affiliated Hospital of KunMing Medical college	Kunming	Yunnan
China	Changhai Hoospital of Shanghai	Shanghai
China	Beijing Jishuitan Hospital	Taiyuan	Shanxi
China	The 3rd People's Hospital of Wuxi	Wuxi	Jiangsu
China	Xijing Hospital	XiAn	Shanxi
China	The First People's Hospital of ZhengZhou	Zhenzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Healing	Healing will be defined as number of days	4 weeks
Secondary	Percent of Burn Epithelised/Healed	Healing will be defined as 95% or more epithelialisation	4 weeks
Secondary	Number of Dressing Changes	Number of dressing changes including first assembly	4 weeks
Secondary	% of Study Burn Healed After One Week		1 week