HIP-STITCH (Wound Recovery After THA)

Официальное название

The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty

Обзор

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.

Вмешательства

• Устройство Ethicon Monocryl Smooth Suture
  Monocryl Smooth Suture 3-0 antibacterial with PS-2 needle. Monofilament suture, placed subcutaneously to approximate the superficial wound edges. Currently used in standard care.
• Устройство Ethicon Vicryl Rapide Braided Suture
  Vicryl Rapide Braided Suture 3-0 with FS-2 needle. Multifilament suture, placed subcutaneously to approximate the superficial wound edges. Currently used in standard care.
• Устройство Flexifuze Indermil Topical Skin Adhesive
  Flexifuze Indermil Topical Skin Adhesive. The skin glue is applied after the application of the suture to further seal the wound from the external environment. Currently used in standard care.
• Устройство Dermabond Prineo Skin Closure System
  Dermabond Prineo Skin Closure System. 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 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.
• Устройство Stryker Zip Skin Closure System
  Stryker Zip Skin Closure System. 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, b

Первичные конечные точки

• Number of Participants with Aberrant Wound Recovery [Срок оценки: Up to fourteen days postoperatively]

Вторичные конечные точки (7)

• Number of Participants with Superficial or Deep Wound Infection [Срок оценки: Up to ninety days postoperatively]
• Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire) [Срок оценки: Fourteen and ninety days postoperatively]
• Costs [Срок оценки: Up to ninety days postoperatively.]
• Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire) [Срок оценки: Fourteen days postoperatively]
• Patient reported outcome measure: Number of Participants with Other postoperative symptoms [Срок оценки: Fourteen days and ninety days postoperatively]
• Number and Type of Complications [Срок оценки: Up to ninety days postoperatively]
• Number of Visits to a Healthcare Professional [Срок оценки: Up to ninety days postoperatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Reinier Haga Orthopedisch Centrum — Zoetermeer

Идентификаторы

NCT: NCT06275776 · OC-2022-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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