HIP-STITCH (Wound Recovery After THA)

NCT06275776 | Recruiting FDA Device

• 1 other identifier: OC-2022-005
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aberrant wound recovery; Total Hip Arthroplasty; Anterior approach; Monocryl Smooth Suture; Vicryl Rapide Braided Suture; Indermil Topical Skin Adhesive; Dermabond Prineo Skin Closure System; Stryker Zip Skin Closure System

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Aberrant Wound Recovery

  Based on a self-developed classification model to assess the early wound recovery (within fourteen days postoperatively), a decision will be made whether the test subjects wound recovery is labelled as either ''normal wound recovery'', ''chance of aberrant wound recovery'', or ''aberrant wound recovery''.

  Up to fourteen days postoperatively

Secondary Outcomes (7)

• Number of Participants with Superficial or Deep Wound Infection

  Up to ninety days postoperatively

• Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)

  Fourteen and ninety days postoperatively

• Costs

  Up to ninety days postoperatively.

• Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)

  Fourteen days postoperatively

• Patient reported outcome measure: Number of Participants with Other postoperative symptoms

  Fourteen days and ninety days postoperatively

Study Arms (4)

Monocryl Smooth Suture

ACTIVE COMPARATOR

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.

Device: Ethicon Monocryl Smooth Suture

Vicryl Rapide + Indermil

ACTIVE COMPARATOR

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.

Device: Ethicon Vicryl Rapide Braided Suture; Device: Flexifuze Indermil Topical Skin Adhesive

Dermabond Prineo

EXPERIMENTAL

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.

Device: Dermabond Prineo Skin Closure System

Stryker Zip

EXPERIMENTAL

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.

Device: Stryker Zip Skin Closure System

Interventions

Ethicon Monocryl Smooth Suture 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.

Monocryl Smooth Suture

Ethicon Vicryl Rapide Braided Suture 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.

Vicryl Rapide + Indermil

Flexifuze Indermil Topical Skin Adhesive 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.

Vicryl Rapide + Indermil

Dermabond Prineo Skin Closure System 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.

Dermabond Prineo

Stryker Zip Skin Closure System 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.

Stryker Zip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Reinier Haga Orthopedisch Centrum: lead

Study Sites (1)

Reinier Haga Orthopedisch Centrum

Zoetermeer, South Holland, 2725NA, Netherlands

RECRUITING

Study Officials

• Stephan BW Vehmeijer, Dr.

  Reinier Haga Orthopedisch Centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brechtje Hesseling, Msc

CONTACT

003179-2065595; onderzoek@rhoc.nl

Nina MC Mathijssen, Dr.

CONTACT

003179-2065595; onderzoek@rhoc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 23, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)