Clinical trial NCT06275776: HIP-STITCH (Wound Recovery After THA)
Official title: The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Reinier Haga Orthopedisch Centrum
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Number of Participants with Aberrant Wound Recovery
timeFrame: Up to fourteen days postoperatively
Secondary outcomes:
measure: Number of Participants with Superficial or Deep Wound Infection
timeFrame: Up to ninety days postoperatively
measure: Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)
timeFrame: Fourteen and ninety days postoperatively
measure: Costs
timeFrame: Up to ninety days postoperatively.
measure: Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)
timeFrame: Fourteen days postoperatively
measure: Patient reported outcome measure: Number of Participants with Other postoperative symptoms
timeFrame: Fourteen days and ninety days postoperatively
measure: Number and Type of Complications
timeFrame: Up to ninety days postoperatively
measure: Number of Visits to a Healthcare Professional
timeFrame: Up to ninety days postoperatively.
Other outcomes:
Locations:
city: Zoetermeer
country: Netherlands
facility: Reinier Haga Orthopedisch Centrum
state: Zuid Holland
Study officials:
affiliation: Reinier Haga Orthopedisch Centrum
name: Stephan BW Vehmeijer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: