HIP-STITCH (Wound Recovery After THA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2028-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Wound Healing Disturbance of

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Test subjects are randomised into one of four study arms. Each study arm corresponds with one of the suturing techniques that are going to be used to close the superficial skin after Total Hip Arthroplasty.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ethicon Monocryl Smooth Suture

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Ethicon Vicryl Rapide Braided Suture

Intervention Type DEVICE

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.

Flexifuze Indermil Topical Skin Adhesive

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Dermabond Prineo Skin Closure System

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

Stryker Zip Skin Closure System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No