HIP-STITCH (Wound Recovery After THA)

Summary

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.

Conditions

• Wound Healing Disturbance of

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, but elsewhere it is being used.

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum

  lead OTHER

Principal Investigators

• Stephan BW Vehmeijer, Dr. · Reinier Haga Orthopedisch Centrum

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-28

Primary Completion

2028-03-01

Completion

2028-05-01

FDA Device

Yes

Countries

• Netherlands

Study Locations