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

Primary Purpose

Burn Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mepilex Ag
Silver Sulphadiazine Ag cream
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injuries focused on measuring Burn injuries, Mepilex Ag, SSD Ag, Partial thickness

Eligibility Criteria

5 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The 1st People's Hospital of Foshan
  • Guangzhou red Cross Hospital
  • The First People's Hospital of ZhengZhou
  • The 3rd People's Hospital of Wuxi
  • Beijing Jishuitan Hospital
  • Xijing Hospital
  • The 2nd affiliated Hospital of KunMing Medical college
  • Beijing Children's Hospital
  • Changhai Hoospital of Shanghai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mepilex Ag

Silver Sulphadiazine Ag cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to Healing
Healing will be defined as number of days

Secondary Outcome Measures

Percent of Burn Epithelised/Healed
Healing will be defined as 95% or more epithelialisation
Number of Dressing Changes
Number of dressing changes including first assembly
% of Study Burn Healed After One Week

Full Information

First Posted
September 21, 2011
Last Updated
November 10, 2017
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01439074
Brief Title
Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injuries
Keywords
Burn injuries, Mepilex Ag, SSD Ag, Partial thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepilex Ag
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Silver Sulphadiazine Ag cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mepilex Ag
Other Intervention Name(s)
Absorbent foam silver dressing
Intervention Description
Dressing
Intervention Type
Drug
Intervention Name(s)
Silver Sulphadiazine Ag cream
Other Intervention Name(s)
SSD Ag cream, 1% SSD Ag, 40g/tube
Intervention Description
A cream used on burnt areas.
Primary Outcome Measure Information:
Title
Time to Healing
Description
Healing will be defined as number of days
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent of Burn Epithelised/Healed
Description
Healing will be defined as 95% or more epithelialisation
Time Frame
4 weeks
Title
Number of Dressing Changes
Description
Number of dressing changes including first assembly
Time Frame
4 weeks
Title
% of Study Burn Healed After One Week
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; isolated burn area (not head and/or face) 2nd degree deep partial 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zia Zhaofan
Organizational Affiliation
Changahai Hospital of Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st People's Hospital of Foshan
City
Guangdong
State/Province
Guangdong
Country
China
Facility Name
Guangzhou red Cross Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Facility Name
The First People's Hospital of ZhengZhou
City
Zhenzhou
State/Province
Henan
Country
China
Facility Name
The 3rd People's Hospital of Wuxi
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
Beijing Jishuitan Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
30009
Country
China
Facility Name
Xijing Hospital
City
XiAn
State/Province
Shanxi
Country
China
Facility Name
The 2nd affiliated Hospital of KunMing Medical college
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Beijing Children's Hospital
City
Beijing
Country
China
Facility Name
Changhai Hoospital of Shanghai
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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