Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Blinded assesment of wound healing at day 18-20.
研究概览
简要总结
The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.
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)
盲法说明
Blinded photo assesment of wound healing by two independent trained clinical doctors.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing
- •Presenting relevant medical record report at study initiation
- •Written informed consent obtained from subject
- •Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation.
排除标准
- •A subjects with major systemic disease not yet stabilized
- •Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
- •Pregnant or breast feeding
- •Unable to follow the outlined study protocol
- •Participation in other studies at the same time that may affect the wound healing.
研究组 & 干预措施
MMS + Autologous patch
Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch.
干预措施: MMS + Autologous patch (Procedure)
MMS + Secondary intention healing
Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing
干预措施: MMS and secondary intention healing (Procedure)
结局指标
主要结局
Blinded assesment of wound healing at day 18-20.
时间窗: Day 18-20
Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no.
次要结局
- Blinded assesment of wound healing at day 11-13(day 11-13)
- Difference in microbiology between intervention wounds and control wounds.(day 1 and day 11-13)
- Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up.(6 months)
- TEWL measurement(day 11-13 and day 18-20)
研究者
Katrine Elisabeth Karmisholt
MD, Chief Consultant, Ass.Prof., PhD
Bispebjerg Hospital