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临床试验/NCT05984862
NCT05984862尚未招募不适用

Bandage Versus No-Bandage After Follicular Unit Extraction Hair Transplantation

Pak Medical and Diagnostic Center0 个研究点目标入组 25 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
主要终点
Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)

研究概览

简要总结

The aim of this interventional study is to determine the role of bandage on the follicular donor sites on the scalp after FUE hair transplantation.

A randomized side of the scalp will be covered using bandage, the other side will be left naked. Subjects under study will be evaluated after the procedure is completed, and day 1 and day 7 post-procedure during the healing phase. This will in turn help, answering the importance of bandage in healing of the donor site post-hair transplantation.

详细描述

In this modern era, hair-transplantation has become very common. Interests in wound healing is not new; with every passing day, different techniques are introduced to get better results for the patients. The current literature available online shows that many hair-transplant centers have stated about using bandage on the donor area post-transplantation, however, there isn't a single study available to augment this use of bandage. On the other hand, data regarding application of antibiotic ointments and silicon gels is available. The punctures made during FUE are only of 9-10mm, requiring no sutures. In addition to this, the blood supply of the scalp also favors quick healing. The process of re-epithelization starts within a few hours of injury and progresses over the first 1 to 3 days. Most of the clinics remove, the bandage after 24hrs, disrupting the healing process of the skin. In the present study, the investigators sought to compare bandage versus no-Bandage donor site in terms of healing. The investigators hypothesize that, compared with bandage site, no-bandage donor site after FUE will have reduce post-procedural downtime and donor site inflammation ultimately, enhancing patient satisfaction with the procedure. The long-term goal of this study is to get evidence-based usage of bandage, if results are in contrast with the hypothesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

This is a randomized, triple-blind, split-scalp study. The subjects will know what side of the scalp the bandage products are applied. However, during evaluation, the subjects and analyst will be shown close-up pictures of the two sides without exposing the patient's identity and actual sides.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 18 years old
  • Able to provide informed consent
  • Planning to undergo follicular unit extraction hair restoration

排除标准

  • Significant medical or surgical conditions
  • Unable to give informed consent
  • Immunocompromised

结局指标

主要结局

Wound healing change over time from day 0 to day +1 (+1), to day +7 (±1)

时间窗: duration of the study be evaluated and rated on days 1 (+1) and 7 (±1) post procedure for both the bandage and no bandage sites

Bandage has protection role to some extent; however, removal of bandage will affect the normal healing of donor site. Healing Response (4-point ordinal scale) LEFT SIDE * Not healed at all (0%) * Mildly healed (33%) * Moderately healed (66%) * Completely healed (100%) RIGHT SIDE * Not healed at all (0%) * Mild healing (33%) * Moderately healed (66%) * Completely healed (100%)

次要结局

未报告次要终点

研究者

发起方
Pak Medical and Diagnostic Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Sarfraz Khan

Research Associate

Pak Medical and Diagnostic Center

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Role of Bandage After FUE Hair Transplantation | 临床试验