Effectiveness of Hyaluronic Acid in Postoperative Cures in Partial Matriceptomes With the Phenol/Alcohol Technique. Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time elapsed until the primary healing and total healing of the wound
研究概览
简要总结
The purpose of this study is to compare the efficacy of a postoperative treatment protocol with hyaluronic acid-based ointment compared to the standard protocol (betadine gel) in partial chemical matricectomies with phenol alcohol technique. This will allow to see if the use of hyaluronic acid could help to reduce the healing time and total recovery of this surgical technique
详细描述
A randomized controlled multicenter study will be conducted. Subject (n=60) will be adolescent and healthy adults, between 14 and 40 years old, who require and demand surgical treatment of onychocryptosis or stage I or IIa ingrown nail in the participating centers.
After acceptance to participate in the study, they will be operated on in a standardized protocol with phenol-alcohol technique. Then they will be randomly assigned into 2 groups, to perform different treatment protocols. The experimental group will receive physiological cures using pure hyaluronic acid (Hialucic®) after the onychocryptosis surgery, while the control group will receive traditional cure (Betadine Gel). The periodicity of cures in both groups will be the same, 48 hours, 6 days, 12 days 16 days and 20 days. For the design of the study, the bases on randomized clinical studies described in CONSORT will be followed.
The outcome measurement will be the presence of exudate in each of the cures (carried out at the same post-surgical times), presence or absence of granulation tissue, reduction of inflammation (measured with the circumference of the finger in the eponychium area), cost average treatment protocol, time elapsed until primary healing (when the wound stops staining the bandage) and final surgical discharge (finger without wound or inflammation), referred pain in the finger during the healing period and presence of complications, such like persistent inflammation, infection, etc.
PARTICIPANTS
Participants will be recruited through the Podiatric Clinic of the University of Extremadura and Lopezosa y Gijon Nogueron clinics in Malaga and Granada
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)
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 14 and 40 years old
- •Patients with stage I, II, or III onychocryptosis (Kline classification) or Mozena stage I or IIa
- •Patients with onychocryptosis unilateral or bilateral.
- •Healthy patients without previous systematic pathologies (diabetes, coagulation or immunological disorders) who require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
排除标准
- •Onychocyptosis with significant involvement of the hypertrophic labrum
- •Severe paronychias
- •Allergy to any of the substances used in the intervention or in the cures.
研究组 & 干预措施
Physiological cures using pure hyaluronic acid (Hialucic®)
After the intervention of unilateral onychocryptosis, the partial matricectomy technique with phenol / alcohol,next to an ointment with hyaluronic acid (hyalucic ®) will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding
干预措施: Hialucic (Drug)
Control group using traditional cure (Betadine Gel).
After the intervention of unilateral onychocryptosis, the partial matricectomy technique with phenol / alcohol,next to Povidone Iodine Gel (Betadine Gel®) will be applied following the same procedure.
干预措施: Betadine gel (Drug)
结局指标
主要结局
Time elapsed until the primary healing and total healing of the wound
时间窗: from the intervention until 15 weeks late
We measure the days that the patients wait to see the wound perfectly between 0 days until 300 days
次要结局
- Presence of complications such as infection(from the intervention until 15 weeks late)
- Presence of exudate(from the intervention until 15 weeks late)
- Reduction of inflammation(from the intervention until 15 weeks late)
- Visual analog scale pain(from the intervention until 15 weeks late)
- cost(from the intervention until 15 weeks late)
研究者
Gabriel Gijon-Nogueron
Associate Professor
University of Malaga