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

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ClinicalTrials.gov Identifier: NCT01439074
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : October 1, 2014
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB

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.

Condition or disease Intervention/treatment Phase
Burn Injuries Device: Mepilex Ag Drug: Silver Sulphadiazine Ag cream Not Applicable

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  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

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 Name: 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 Name: SSD Ag cream, 1% SSD Ag, 40g/tube



Primary Outcome Measures :
  1. Time to Healing [ Time Frame: 4 weeks ]
    Healing will be defined as number of days


Secondary Outcome Measures :
  1. Percent of Burn Epithelised/Healed [ Time Frame: 4 weeks ]
    Healing will be defined as 95% or more epithelialisation

  2. Number of Dressing Changes [ Time Frame: 4 weeks ]
    Number of dressing changes including first assembly

  3. % of Study Burn Healed After One Week [ Time Frame: 1 week ]


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Ages Eligible for Study:   5 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439074


Locations
China, Guangdong
The 1st People's Hospital of Foshan
Guangdong, Guangdong, China
Guangzhou red Cross Hospital
Guangzhou, Guangdong, China, 510220
China, Henan
The First People's Hospital of ZhengZhou
Zhenzhou, Henan, China
China, Jiangsu
The 3rd People's Hospital of Wuxi
Wuxi, Jiangsu, China
China, Shanxi
Beijing Jishuitan Hospital
Taiyuan, Shanxi, China, 30009
Xijing Hospital
XiAn, Shanxi, China
China, Yunnan
The 2nd affiliated Hospital of KunMing Medical college
Kunming, Yunnan, China
China
Beijing Children's Hospital
Beijing, China
Changhai Hoospital of Shanghai
Shanghai, China
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Zia Zhaofan Changahai Hospital of Shanghai

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01439074     History of Changes
Other Study ID Numbers: PUMA 418
First Posted: September 22, 2011    Key Record Dates
Results First Posted: October 1, 2014
Last Update Posted: December 18, 2017
Last Verified: December 2013

Keywords provided by Molnlycke Health Care AB:
Burn injuries
Mepilex Ag
SSD Ag
Partial thickness

Additional relevant MeSH terms:
Wounds and Injuries
Burns
Sulfadiazine
Silver Sulfadiazine
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local