protocolSection identificationModule nctId: NCT06275776, orgStudyIdInfo id: OC-2022-005, briefTitle: HIP-STITCH (Wound Recovery After THA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Reinier Haga Orthopedisch Centrum, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Wound Healing Disturbance of, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 236, type: ESTIMATED, armsInterventionsModule interventions name: Ethicon Monocryl Smooth Suture, interventions name: Ethicon Vicryl Rapide Braided Suture, interventions name: Flexifuze Indermil Topical Skin Adhesive, interventions name: Dermabond Prineo Skin Closure System, interventions name: Stryker Zip Skin Closure System, outcomesModule primaryOutcomes measure: Number of Participants with Aberrant Wound Recovery, secondaryOutcomes measure: Number of Participants with Superficial or Deep Wound Infection, secondaryOutcomes measure: Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire), secondaryOutcomes measure: Costs, secondaryOutcomes measure: Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire), secondaryOutcomes measure: Patient reported outcome measure: Number of Participants with Other postoperative symptoms, secondaryOutcomes measure: Number and Type of Complications, secondaryOutcomes measure: Number of Visits to a Healthcare Professional, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reinier Haga Orthopedisch Centrum, city: Zoetermeer, state: Zuid Holland, zip: 2725NA, country: Netherlands, contacts name: Brechtje Hesseling, Msc, role: CONTACT, phone: 003179-2065595, email: onderzoek@rhoc.nl, contacts name: Nina MC Mathijssen, Dr., role: CONTACT, phone: 003179-2065595, email: onderzoek@rhoc.nl, geoPoint lat: 52.0575, lon: 4.49306, hasResults: False