NCT06143683尚未招募不适用
The Impact of Early Versus Late Upper Extremity Mobilization After Meshed / Sheet Split Thickness Skin Autograft on Wound Healing in Adult Burn Patients - A Single Center Non-Inferiority Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Wound healing measured as percent graft take on POD5 (± 2 days)
研究概览
简要总结
STSGs are used to close wounds and minimize infections. After receiving a meshed or sheet split-thickness skin graft (STSG) to the upper extremity or hand for a thermal burn injury, burn surgeons use different methods to improve graft take and reduce complications. This includes different start dates and times for activity.
The goal of this clinical trial is to provide more evidence to improve rehabilitation procedures after STSG operations for patients with burn injuries. The main question[s] it aims to answer are:
- To determine if early mobilization is non-inferior to late mobilization of the upper extremity after meshed STSG with regards to wound healing in adult burn patients.
- To determine if early mobilization is non-inferior to late mobilization of the upper extremity after sheet STSG with regards to wound healing in adult burn patients
Participants will be assigned randomly (like flipping a coin) to one of two groups: early mobilization and late mobilization. Mobilization is the range of motion exercises performed under the supervision of the physical therapy team. Researchers will compare early and late mobilization to see if there are differences in wound healing, range of motion, local and systemic complications, and discharge outcomes.
Participants will be asked to:
- Early mobilization group: begin mobilization of their upper extremity one day after their STSG operation. If their burn includes a graft to your hand, early mobilization of this area will begin three days after their STSG operation.
- Late mobilization group: elevate their elbow in a splint to limit movement until five days after their operation and begin mobilization five days after their STSG operation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years and older at the time of surgery.
- •Injury: Acute (within 72h of injury) thermal flame or scald burn.
- •Surgery: Skin split-thickness meshed autograft (STSG) and/or sheet split thickness autograft (STSG) applied directly on the wound bed.
- •Location:
- •Upper extremity burn - distal to the axilla and proximal to the wrist. The axilla is a difficult area to graft due to its three-dimensional configuration, hence the healing of this area is not comparable to others.
- •The hand that will undergo sheet STSG
排除标准
- •Injury: Electrical and chemical burn. The pathophysiology of electrical or chemical burns is not comparable to flame or scald burns, hence their exclusion.
- •Location: Autograft exclusively to the wrist, axilla, or non-upper extremity. The wrist is a sensitive areas with many joints in close proximity. The loss of graft in this area can be devastating to the patient and will therefore be evaluated only once we have evidence to support the safety of mobilization in upper extremity grafts.
- •Patients on vasopressors the day of the operation. Vasopressors cause peripheral vasoconstriction, leading to decreased wound healing capacity. Patients on vasopressors are also usually systemically unwell and should therefore not be included in an elective clinical trial on extremity mobilization.
- •Pre-existing comorbidities causing upper extremity mobility restrictions.
- •Patient unable to comply with mobilization protocol.
结局指标
主要结局
Wound healing measured as percent graft take on POD5 (± 2 days)
时间窗: From autografting until five days afterwards
次要结局
- Range of motion of the hand(From autografting until 14 days afterwards)
- Days to discharge from the Burn Unit(From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).)
- Incidence of post-operative local complications (seroma, hematoma, infection, graft loss) or systemic complications (infection, deep vein thrombosis, pulmonary embolism, mortality)(From autografting until 14 days afterwards)
- Severity of graft site pain(From autografting until five days afterwards)
- Range of motion of the elbow joint(From autografting until 14 days afterwards)
- Days between admission to the burn unit and the date of discharge.(From admission to the burn unit until discharge (approximately 2 days for every 1% total body surface area burn).)
- Percent graft healed at POD 14 (± 2 days)(From autografting until 14 days afterwards)
研究者
相似试验
已完成
1 期
Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer DressingLate Complication From Skin GraftInfection of Skin Donor SiteImpaired Wound HealingPain, IntractableNCT02091076Chulalongkorn University29
已完成
不适用
Evaluation of Wound Infection Rates and Cosmetic Results of Different Suture Materials in Cesarean Skin IncisionCesarean Section InfectionScarNCT06119113Ayşenur Çalış Özbayram300
Unknown
不适用
Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue GraftThe Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the HealingNCT04780360Cairo University20
Unknown
2 期
Role of Mesh Stoma Reinforcement Technique (MSRT) in Prevention of Parastomal Hernia After Ileal Conduit Urinary DiversionIleal ConduitParastomal HerniaNCT02387333Mansoura University40
已完成
1 期
Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites TreatmentLate Complication From Skin GraftInfection of Skin Donor SiteImpaired Wound HealingPain, IntractableNCT01539980Chulalongkorn University30