An Open, Randomized, Multi-centre Investigation With Mepilex Ag Versus Silver Sulfadiazine in the Treatment of Deep Partial Thickness Burn Injuries.
This study is currently recruiting participants.
Verified July 2012 by Molnlycke Health Care AB
Sponsor:
Molnlycke Health Care AB
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01439074
First received: September 21, 2011
Last updated: May 17, 2013
Last verified: July 2012
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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: Yes ]
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 epithalisation
- Number of dressing changes [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 284 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 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;
- isolated burn area (not head and/or face)
- 2nd 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).
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439074
Contacts
| Contact: Lina Chang, MD | +8610 51288571 ext 820 | lina.chang@molnlycke.se |
Locations
| China, Guangdong | |
| Guangzhou red Cross Hospital | Recruiting |
| Gang Zhou, Guangdong, China, 510220 | |
| Contact: Yeyang Li, MD +8613503076154 yeyangli@126.com | |
| Principal Investigator: Yeyang Li, MD | |
| China, Henan | |
| The First People's Hospital of ZhengZhou | Recruiting |
| Zhenzhou, Henan, China | |
| Contact: Xihua Niu, MD +8613837171667 13837171667@163.com | |
| Principal Investigator: Xihua Niu, MD | |
| The first People's hospital of ZhengZhou | Recruiting |
| Zhenzhou, Henan, China | |
| Contact: Niu Xihua, Principal Investigator 13837171667@163.com | |
| Principal Investigator: Niu Xihua, MD | |
| China, Hunan | |
| Xiangya Hospital Central-South University | Withdrawn |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| Jiangsu Jiangyin Peopl's Hospital, affiliated hospital of Medical College of Southeast University | Active, not recruiting |
| Jiangyin, Jiangsu, China | |
| The 3rd People's Hospital of Wuxi | Recruiting |
| Wuxi, Jiangsu, China | |
| Contact: Guozhong Lv, MD +8613806183990 luguozhong@hotmail.com | |
| Principal Investigator: Guozhong Lv, MD | |
| China, Shanxi | |
| Beijing Jishuitan Hospital | Not yet recruiting |
| Taiyuan, Shanxi, China, 30009 | |
| Contact: Zhang Guo'an, MD | |
| Principal Investigator: Zhang Guo'an, MD | |
| Xijing Hospital | Recruiting |
| XiAn, Shanxi, China | |
| Contact: Dahai Hu, MD +8613992863526 hudhai@fmmu.edu.cn | |
| Principal Investigator: Dahai Hu, MD | |
| Taiyuan Steel burn centre | Recruiting |
| XingHuaLing District, Taiyuan, Shanxi, China | |
| Contact: Lei Jin, MD leijinld@163.com | |
| Principal Investigator: Lei Jin, MD | |
| China, Yunnan | |
| The 2nd affiliated Hospital of KunMing Medical college | Recruiting |
| XiShan District, Kunming, Yunnan, China | |
| Contact: Fu Jinfeng, MD | |
| Principal Investigator: Fu Jinfeng, MD | |
| China | |
| Changhai Hoospital of Shanghai | Recruiting |
| Shanghai, China | |
| Contact: Hongtai Tang, MD +8613 386272196 drhttang@yahoo.com.cn | |
| Principal Investigator: Zhaofan Xia, MD | |
| Shanxi Province Burn Care Centre | Withdrawn |
| Shanxi Province, China, 30003 | |
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 |
| Last Updated: | May 17, 2013 |
| 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, Local Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Coccidiostats |
ClinicalTrials.gov processed this record on May 23, 2013