The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Number of Participants with Aberrant Wound Recovery
研究概览
简要总结
This prospective randomised trial will investigate the effect of four different suturing techniques (Monocryl, Vicryl Rapide with Indermil skin glue, Dermabond Prineo, and Stryker Zip) on the amount of aberrant wound recovery within 14 days after total hip arthroplasty at the RHOC in Zoetermeer, The Netherlands.
This will be done by assessing photographs of the plaster and photographs of the operation wound with a self-developed classification model. The photographs of the plaster will be taken by the test subject at home at 3 days and 11 days postoperatively.
The photographs of the operation wound will be taken by a member of the research team, and the doctor's assistant, respectively, during a visit to the outpatient clinic at 7 days and 14 days postoperatively.
Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery within fourteen days after primary THA.
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
No one in this study can reasonably be blinded for the suturing technique during the duration of the study, since the suturing techniques differ substantially in shape, appearance and size. The only blinding in this study is the blinding of the outcome assessor to data of the test subjects. The assessor will only see the photographs of the wound/plaster, and the moment on which the photograph was taken. Additional information on the test subject, such as age, comorbidities, et cetera, will be withheld from the assessor.
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
- •Eighteen years or older.
- •Scheduled to undergo Total Hip Arthroplasty via the anterior approach for any indication at the RHOC.
- •No prior operations to the hip which is to be operated on.
- •A good command of the Dutch language
- •Able to give written informed consent.
排除标准
- •Usage of cytostatics in the period ranging from fourteen days prior, to ninety days after the operation.
- •Unable to, or difficulty with communicating in the Dutch language (e.g. due to mental disability, inability to understand/speak/write Dutch, et cetera).
研究组 & 干预措施
Monocryl Smooth Suture
Study arm consisting of participants receiving Monocryl Smooth Suture for closure of the superficial skin. Monofilament suture, placed subcutaneously to approximate the wound edges. Currently used in standard care.
干预措施: Ethicon Monocryl Smooth Suture (Device)
Vicryl Rapide + Indermil
Study arm consisting of participants receiving Vicryl Rapide Braided Suture in combination with Indermil Topical Skin Adhesive for closure of the superficial skin. Multifilament suture, placed subcutaneously to approximate the wound edges. Skin glue is applied after the application of the suture to further seal the wound from the external environment. Currently used in standard care.
干预措施: Ethicon Vicryl Rapide Braided Suture (Device)
Vicryl Rapide + Indermil
Study arm consisting of participants receiving Vicryl Rapide Braided Suture in combination with Indermil Topical Skin Adhesive for closure of the superficial skin. Multifilament suture, placed subcutaneously to approximate the wound edges. Skin glue is applied after the application of the suture to further seal the wound from the external environment. Currently used in standard care.
干预措施: Flexifuze Indermil Topical Skin Adhesive (Device)
Dermabond Prineo
Study arm consisting of participants receiving Dermabond Prineo Skin Closure System for closure of the superficial skin. Relatively novel skin closure system consisting of a self-adhesive transparent mesh, over which skin glue is applied as well. This system approximates the wound edges, shields the wound from the external environment, enables healthcare professionals to still be able to see the wound and surrounding tissue, and eliminates the invasive aspect of conventional sutures. Currently not used in standard care at the RHOC, but elsewhere it is being used.
干预措施: Dermabond Prineo Skin Closure System (Device)
Stryker Zip
Study arm consisting of participants receiving Stryker Zip Skin Closure System for closure of the superficial skin. Relatively novel skin closure system consisting of two self-adhesive strips placed parallel to either side of the wound. Zip tie/Cable tie-like structures running perpendicular to the adhesive strips can be tightened to approximate the wound edges and thusly close the wound. This system enables healthcare professionals to still see the wound and surrounding tissue, and eliminates the invasive aspect of conventional sutures. Currently not used in standard care at the RHOC, but elsewhere it is being used.
干预措施: Stryker Zip Skin Closure System (Device)
结局指标
主要结局
Number of Participants with Aberrant Wound Recovery
时间窗: Up to fourteen days postoperatively
Based on a self-developed classification model to assess the early wound recovery (within fourteen days postoperatively), a decision will be made whether the test subjects wound recovery is labelled as either ''normal wound recovery'', ''chance of aberrant wound recovery'', or ''aberrant wound recovery''.
次要结局
- Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)(Fourteen days postoperatively)
- Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)(Fourteen and ninety days postoperatively)
- Patient reported outcome measure: Number of Participants with Other postoperative symptoms(Fourteen days and ninety days postoperatively)
- Number and Type of Complications(Up to ninety days postoperatively)
- Number of Participants with Superficial or Deep Wound Infection(Up to ninety days postoperatively)
- Costs(Up to ninety days postoperatively.)
- Number of Visits to a Healthcare Professional(Up to ninety days postoperatively.)