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Recruiting NCT06275776

HIP-STITCH (Wound Recovery After THA)

No phase Interventional Wound Healing Disturbance of

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ethicon Monocryl Smooth Suture, Ethicon Vicryl Rapide Braided Suture, Flexifuze Indermil Topical Skin Adhesive, Dermabond Prineo Skin Closure System.
Who it may be relevant to
Registry conditions: Wound Healing Disturbance of. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.
  • Device 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.
  • Device 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.
  • Device 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

Primary outcome measures

  • Number of Participants with Aberrant Wound Recovery [Time frame: Up to fourteen days postoperatively]
Secondary outcome measures (7)
  • Number of Participants with Superficial or Deep Wound Infection [Time frame: Up to ninety days postoperatively]
  • Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire) [Time frame: Fourteen and ninety days postoperatively]
  • Costs [Time frame: Up to ninety days postoperatively.]
  • Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire) [Time frame: Fourteen days postoperatively]
  • Patient reported outcome measure: Number of Participants with Other postoperative symptoms [Time frame: Fourteen days and ninety days postoperatively]
  • Number and Type of Complications [Time frame: Up to ninety days postoperatively]
  • Number of Visits to a Healthcare Professional [Time frame: Up to ninety days postoperatively.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Reinier Haga Orthopedisch Centrum — Zoetermeer

Identifiers

NCT: NCT06275776 · OC-2022-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗