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

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.

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.

Study Overview

• Status: Completed
• Conditions: Burn Injuries
• Intervention / Treatment: Device: Mepilex Ag; Drug: Silver Sulphadiazine Ag cream

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital
  • Shanghai, China
    • Changhai Hoospital of Shanghai
  • Guangdong
    • Guangdong, Guangdong, China
      • The 1st People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510220
      • Guangzhou red cross hospital
  • Henan
    • Zhenzhou, Henan, China
      • The first People's Hospital of Zhengzhou
  • Jiangsu
    • Wuxi, Jiangsu, China
      • The 3rd People's Hospital of Wuxi
  • Shanxi
    • Taiyuan, Shanxi, China, 30009
      • BeiJing JiShuiTan Hospital
    • XiAn, Shanxi, China
      • Xijing Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The 2nd affiliated Hospital of KunMing Medical college

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mepilex Ag; Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.	Device: Mepilex Ag; Dressing; Other Names: Absorbent foam silver dressing
Active Comparator: Silver Sulphadiazine Ag cream; SSD Ag cream is white cream, 1% SSD Ag, 40g/tube This cream is indicated for prevent and treat secondary wound infection of small area, mild burn/scald.	Drug: Silver Sulphadiazine Ag cream; A cream used on burnt areas.; Other Names: SSD Ag cream, 1% SSD Ag, 40g/tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Healing	Healing will be defined as number of days	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Burn Epithelised/Healed	Healing will be defined as 95% or more epithelialisation	4 weeks
Number of Dressing Changes	Number of dressing changes including first assembly	4 weeks
% of Study Burn Healed After One Week		1 week

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Zia Zhaofan, Changahai Hospital of Shanghai

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (Estimate): September 22, 2011

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: November 10, 2017
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Burn injuries; Mepilex Ag; SSD Ag; Partial thickness
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: PUMA 418