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An Open, Randomized, Multi-centre Investigation With Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01439074
First received: September 21, 2011
Last updated: September 26, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Burn Injuries
Device: Mepilex Ag
Drug: Silver sulphadiazine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Time to Healing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of days


Secondary Outcome Measures:
  • Percent of Burn Epithelised/Healed [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Healing will be defined as 95% or more epithelialisation

  • Number of Dressing Changes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Including first assembly

  • % of Study Burn Healed After One Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: SSD Ag cream
Silver Sulphadiazine Ag cream
Drug: Silver sulphadiazine
Cream

  Eligibility

Ages Eligible for Study:   5 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439074

Locations
China, Guangdong
Guangzhou red Cross Hospital
Gang Zhou, Guangdong, China, 510220
China, Henan
The First People's Hospital of ZhengZhou
Zhenzhou, Henan, China
China, Jiangsu
Jiangsu Jiangyin Peopl's Hospital, affiliated hospital of Medical College of Southeast University
Jiangyin, Jiangsu, China
The 3rd People's Hospital of Wuxi
Wuxi, Jiangsu, China
China, Shanxi
Beijing Jishuitan Hospital
Taiyuan, Shanxi, China, 30009
Xijing Hospital
XiAn, Shanxi, China
Taiyuan Steel burn centre
XingHuaLing District, Taiyuan, Shanxi, China
China, Yunnan
The 2nd affiliated Hospital of KunMing Medical college
XiShan District, Kunming, Yunnan, China
China
Changhai Hoospital of Shanghai
Shanghai, China
Sponsors and Collaborators
Molnlycke Health Care AB
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01439074     History of Changes
Other Study ID Numbers: PUMA 418
Study First Received: September 21, 2011
Results First Received: September 26, 2014
Last Updated: September 26, 2014
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014