A Prospective, Randomized, Parallel Study to Evaluate the Effectiveness of PermeaDerm® and Mepilex-Ag® in Promoting Healing of Partial-thickness Burn Wounds
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Time to heal
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds: PermeaDerm® (PermeaDerm, Inc., Carlsbad, California, USA) and silver impregnated foam dressing (Mepilex Ag®, Health Care, Göteborg, Sweden)
详细描述
In this prospective, randomized parallel study, the effectiveness of the wound dressings currently used at our institution for partial-thickness burn wounds will be compared: PermeaDerm®, and silver coated foam dressing Mepilex Ag®.This study is therefore considered a minimal risk study. Procedures related to research apart from randomization to one of the dressings, will include review of medical records, non-invasive wound and scar assessments and additional photographs.
60 patients with partial thickness burns meeting the inclusion criteria of the study will be enrolled to receive either PermeaDerm® (n=30) or silver coated foam dressing (Mepilex Ag®; n=30) in an outpatient or observational setting.
Prior to placement of wound dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Time to heal will be defined as the time after which complete re-epithelialization is reached and PermeaDerm® detaches or there are no more changes of Mepilex Ag® needed. Secondary goals of the study are to assess pain, and scarring associated with the use of the different dressings in our burn patients, as well as to assess cost-effectiveness of the therapy.
Pain will be assessed at every patient visit using visual analog scale (VAS) or Wong-Baker FACES respectively; mid and long-term scar development is assessed at approximately 1 and 6 months after enrollment in the study using Patient and Observer Scar Assessment Scale (POSAS) and DermaLab Combo® (Cortex Technology, Denmark).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Superficial partial thickness burn injury due to flame burn, scald injury or contact burn that does not require excision and grafting
- •Total Body Surface Area burned (TBSA) total ≤30 %
- •Admission within 72 hours of burn injury
- •Non-infected wound as diagnosed by the attending physician upon admission
- •Treated as an outpatient or in an observational setting
排除标准
- •Patient younger than 6 months
- •Causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite)
- •Admission time greater than 72 hours after the injury
- •Wounds noted to be infected at admission
- •Previous treatment efforts such as previous debridement, silver sulfadiazine ointment or other pseudo eschar-forming topical agents
- •Pregnancy/lactation
结局指标
主要结局
Time to heal
时间窗: up to 3 weeks after injury
Time until wound is complete healed in days. A wound is considered as completely healed, when either PermeaDerm detaches on its own or no more dressings need to be applied in the Mepilex group. This time point is defined when approximately 95% of the wound shows epithelialization as determined by an experienced burn surgeon.
次要结局
- Scar assessment with Patient and Observer Assessment Scale (POSAS)(at 6 months post injury)
- Scarring with DermaLab Combo device: Hydration(at 6 months post injury)
- Scarring with DermaLab Combo device: Trans epithermal water loss(at 6 months post injury)
- Scarring with DermaLab Combo device: Pigmentation(at 6 months post injury)
- Scarring with DermaLab Combo device: Viscoelasticity(at 6 months post injury)
- Rate of Infection(at 1 month post burn)
- Pain assessment using Visual Analog Pain Scale (VAS) or Wong-Baker FACES pain rating scales (age dependent)(Changes over first 30 days post injury, using regression modeling for analysis.)
- Cost-effectiveness(at 1 month post burn)