Clinical trial NCT01439074: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burn Injuries
Keywords: Burn injuries
Mepilex Ag
SSD Ag
Partial thickness
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2011-09-22
Enrollment: 162
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

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

Primary outcomes:
measure: Time to Healing
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent of Burn Epithelised/Healed
timeFrame: 4 weeks
measure: Number of Dressing Changes
timeFrame: 4 weeks
measure: % of Study Burn Healed After One Week
timeFrame: 1 week
Other outcomes:
Locations:
city: Guangdong
country: China
facility: The 1st People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou red Cross Hospital
state: Guangdong
city: Zhenzhou
country: China
facility: The First People's Hospital of ZhengZhou
state: Henan
city: Wuxi
country: China
facility: The 3rd People's Hospital of Wuxi
state: Jiangsu
city: Taiyuan
country: China
facility: Beijing Jishuitan Hospital
state: Shanxi
city: XiAn
country: China
facility: Xijing Hospital
state: Shanxi
city: Kunming
country: China
facility: The 2nd affiliated Hospital of KunMing Medical college
state: Yunnan
city: Beijing
country: China
facility: Beijing Children's Hospital
city: Shanghai
country: China
facility: Changhai Hoospital of Shanghai
Study officials:
affiliation: Changahai Hospital of Shanghai
name: Zia Zhaofan
role: PRINCIPAL_INVESTIGATOR
References: