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

NCT01439074 | Completed Results

• 1 other identifier: PUMA 418
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 9

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.

Conditions

Burn Injuries

Keywords

Burn injuries; Mepilex Ag; SSD Ag; Partial thickness

Outcome Measures

Primary Outcomes (1)

• Time to Healing

  Healing will be defined as number of days

  4 weeks

Secondary Outcomes (3)

• Percent of Burn Epithelised/Healed

  4 weeks

• Number of Dressing Changes

  4 weeks

• % of Study Burn Healed After One Week

  1 week

Study Arms (2)

Mepilex Ag

ACTIVE COMPARATOR

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

Silver Sulphadiazine Ag cream

ACTIVE COMPARATOR

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

Interventions

Mepilex Ag DEVICE

Dressing

Also known as: Absorbent foam silver dressing

Mepilex Ag

Silver Sulphadiazine Ag cream DRUG

A cream used on burnt areas.

Also known as: SSD Ag cream, 1% SSD Ag, 40g/tube

Silver Sulphadiazine Ag cream

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• isolated burn area (not head and/or face)
• nd degree deep partial
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (9)

The 1st People's Hospital of Foshan

Guangdong, Guangdong, China

Location

Guangzhou red Cross Hospital

Guangzhou, Guangdong, 510220, China

Location

The First People's Hospital of ZhengZhou

Zhenzhou, Henan, China

Location

The 3rd People's Hospital of Wuxi

Wuxi, Jiangsu, China

Location

Beijing Jishuitan Hospital

Taiyuan, Shanxi, 30009, China

Location

Xijing Hospital

XiAn, Shanxi, China

Location

The 2nd affiliated Hospital of KunMing Medical college

Kunming, Yunnan, China

Location

Beijing Children's Hospital

Beijing, China

Location

Changhai Hoospital of Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Prof Xia, Zhaofan
• Organization: Changhai Hospital of Shanghai

+86 2181873471

Study Officials

• Zia Zhaofan

  Changahai Hospital of Shanghai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 18, 2017
• Results First Posted: October 1, 2014

Record last verified: 2013-12

Locations

CN (9)