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

NCT ID: NCT01439074

Last Updated: 2017-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Burn Injuries

Keywords

Burn injuries; Mepilex Ag; SSD Ag; Partial thickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Mepilex Ag

Intervention Type: DEVICE

Dressing

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.

Group Type: ACTIVE_COMPARATOR

Silver Sulphadiazine Ag cream

Intervention Type: DRUG

A cream used on burnt areas.

Interventions

Mepilex Ag

Dressing

Intervention Type: DEVICE

Silver Sulphadiazine Ag cream

A cream used on burnt areas.

Intervention Type: DRUG

Other Intervention Names

Absorbent foam silver dressing; SSD Ag cream, 1% SSD Ag, 40g/tube

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zia Zhaofan

Role: PRINCIPAL_INVESTIGATOR

Changahai Hospital of Shanghai

Locations

The 1st People's Hospital of Foshan

Guangdong, Guangdong, China

Guangzhou red Cross Hospital

Guangzhou, Guangdong, China

The First People's Hospital of ZhengZhou

Zhenzhou, Henan, China

The 3rd People's Hospital of Wuxi

Wuxi, Jiangsu, China

Beijing Jishuitan Hospital

Taiyuan, Shanxi, China

Xijing Hospital

XiAn, Shanxi, China

The 2nd affiliated Hospital of KunMing Medical college

Kunming, Yunnan, China

Beijing Children's Hospital

Beijing, , China

Changhai Hoospital of Shanghai

Shanghai, , China

Countries

China

Other Identifiers

PUMA 418

Identifier Type: -

Identifier Source: org_study_id