Nanofat on Wound Healing and Scar Formation: a Randomized, Split-scar, Double Blind Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
研究概览
简要总结
This study will evaluate the effectiveness and safety of intradermal injection of Nanofat on wound healing and scar formation.
详细描述
In this monocentric, randomized, controlled, double-blinded prospective interventional study, twenty patients will be included. Each patient will be his/her own control.
Patients undergoing DIEPflap breast reconstruction will be included in this study. During the surgery, the abdominal incision will be divided in two equal sides with the umbilicus as midline reference. The sides will be randomized in a treatment side and control side. The treatment side will receive intradermal nanofat injections after the subcutaneous and right before the intradermal sutures.
The patient and investigators will be blinded for the treatment protocol. The effects on wound healing, adverse events, scar formation and pigmentation will be evaluated up to one year after the surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patient, investigator, outcome assessor will be blinded for which side of the scar was treated and which was a control. Only the surgeon, who will not be involved in the assessment, will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •scheduled for DIEP-flap breast reconstruction surgery at our department
排除标准
- •use of cortisone or other immunsuppressants
- •diabetes mellitus type 1 or 2
- •connective tissue disease
研究组 & 干预措施
Intradermal Nanofat
This side of the scar received intradermal injection of nanofat during the closure of the donor site.
干预措施: Nanofat injection (Procedure)
Control
This side of the scar received no injection.
结局指标
主要结局
Clinical outcome of the abdominal scar by the use of Patient and Observer Scar Assessment Scale
时间窗: one year
The abdominal scar will be evaluated clinically by the patient and observer scar assessment scale, starting from one month after the surgery
Clinical assessment of the time to healing of the abdominal wound
时间窗: one month
The time for the abdominal wound to heal will be registered. Wound healing is considered a closed and non-dehiscent wound witout signs of inflammation or infection.
Patient satisfaction of abdominal scar appearance measured by a Visual Analog Scale
时间窗: one year
Evaluation of patient satisfaction over the entire course of the study by filling in a Visual Analog Scale, with 1 being very unsatisfied and 10 being very satisfied.
Evaluation of histological parameters on tissue biopsy from both sides of the abdominal scar.
时间窗: six months
Evaluation of the histological differences of the treatment arm vs. control, by evaluating scar properties on tissue biopsy. Scar thickness, collagen arrangement and angiogenesis will be evaluated.
Rate of adverse events
时间窗: One year
Registration of the rate of adverse events appearing at the abdominal wound/abdominal scar
Pigmentation Index of the two sides of the scar, measured with a Mexameter
时间窗: one year
Evaluation of the Pigmentation Index difference in the treatment arm vs. control arm will be measured by the use of a mexameter, starting from one month after the procedure (after wound healing is complete).
次要结局
未报告次要终点
研究者
Moustapha Hamdi
Head of department Plastic and Reconstructive surgery
Universitair Ziekenhuis Brussel