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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.

Information source: Molnlycke Health Care AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burn Injuries

Intervention: Mepilex Ag (Device); Silver sulphadiazine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Molnlycke Health Care AB

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to Healing

Secondary outcome:

Percent of Burn Epithelised/Healed

Number of Dressing Changes

% of Study Burn Healed After One Week

Eligibility

Minimum age: 5 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Changhai Hoospital of Shanghai, Shanghai, China

Guangzhou red Cross Hospital, Gang Zhou, Guangdong 510220, China

The First People's Hospital of ZhengZhou, Zhenzhou, Henan, China

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

Beijing Jishuitan Hospital, Taiyuan, Shanxi 30009, China

Xijing Hospital, XiAn, Shanxi, China

Taiyuan Steel burn centre, XingHuaLing District, Taiyuan, Shanxi, China

The 2nd affiliated Hospital of KunMing Medical college, XiShan District, Kunming, Yunnan, China

Additional Information

Starting date: September 2011
Last updated: September 26, 2014

Page last updated: August 23, 2015

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