HIP-STITCH (Wound Recovery After THA)

Reinier Haga Orthopedisch Centrum

Status: Enrolling

Conditions: Wound Healing Disturbance of

Treatments: Device: Dermabond Prineo Skin Closure System; Device: Stryker Zip Skin Closure System; Device: Ethicon Vicryl Rapide Braided Suture; Device: Flexifuze Indermil Topical Skin Adhesive; Device: Ethicon Monocryl Smooth Suture

Study type: Interventional

Funder types: Other

Identifiers

NCT06275776

OC-2022-005

Details and patient eligibility

About

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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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236 participants in 4 patient groups

Monocryl Smooth Suture

Active Comparator group

Description:

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.

Treatment:

Device: Ethicon Monocryl Smooth Suture

Vicryl Rapide + Indermil

Active Comparator group

Description:

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.

Treatment:

Device: Flexifuze Indermil Topical Skin Adhesive

Device: Ethicon Vicryl Rapide Braided Suture

Dermabond Prineo

Experimental group

Description:

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.

Treatment:

Device: Dermabond Prineo Skin Closure System

Stryker Zip

Experimental group

Description:

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.

Treatment:

Device: Stryker Zip Skin Closure System