HIP-STITCH (Wound Recovery After THA)

Not Applicable

Recruiting

• Conditions: Wound Healing Disturbance of

• Registration Number: NCT06275776
• Lead Sponsor: Reinier Haga Orthopedisch Centrum

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-16
• Study First Posted: 2024-02-23
• Study Start: 2024-08-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2028-03-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants with Aberrant Wound Recovery	Up to fourteen days postoperatively	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''.

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)	Fourteen days postoperatively	This question will assess whether or not the test subject thinks he/she could have removed the suturing method himself/herself (or with aid of a friend/relative/etc.). This is not a standardised questionaire, as the investigators have developed it themselves.; This is a scale question with possible answers ranging from one to ten, (One being extremely unlikely to remove the suturing technique, and ten being sure of removing it). A higher score on this question corresponds with a higher possibility of having removed the suturing technique themselves. The participant has to pick one number on the scale. The participant can also opt ''Not applicable in case he/she has received Monocryl (arm in the study). Clear instructions will be given in the questionnaire in order for the participant to know whether they have received this suturing technique or not.; This is done to assess whether a patient would have to come to the outpatient clinic for a control appointment in standard care.
Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)	Fourteen and ninety days postoperatively	Questionnaire to be filled in by the participants. This self-developed questionnaire will assess the participants' satisfaction about the suturing method. This is not a standardised questionaire, as the investigators have developed it themselves.; The satisfaction score will be assessed by means of two scale questions in the questionnaire. The first assessing patient reported satisfaction regarding the suturing technique ranging from one to ten (One being extremely dissatisfied, and ten being fully satisfied).; The second question assesses how likely the participant is to recommend the suturing technique to a relative/friend/etc. from one to ten (One being highly unlikely, and ten being highly likely).; A higher score on these questions corresponds with a higher satisfaction about the suturing technique. The participant has to pick one number on the scales corresponding to the satisfaction about the suturing technique, and the likelihood of recommendation.
Patient reported outcome measure: Number of Participants with Other postoperative symptoms	Fourteen days and ninety days postoperatively	Other symptoms which might have occurred postoperatively. These symptoms include fever, increase in pain, redness of the skin, pus coming from the wound, general feelings of discomfort, contact with the General Practitioner and antibiotics usage. This will be assessed by means of a questionnaire at fourteen en ninety days postoperatively.
Number and Type of Complications	Up to ninety days postoperatively	Postoperative complications as recorded in the electronic patient file. Both the sheer number of complications will be registered per arm, as well as the type of complications that occur per arm.
Number of Participants with Superficial or Deep Wound Infection	Up to ninety days postoperatively	The amount of superficial or deep wound infections that occur in all the arms during the duration of the study. This will be assessed by checking the electronic patient file for contacts that might suggest infection, such as a DAIR, one-step exchange arthroplasty, two-step exchange arthroplasty, Girdlestone, or antibiotics usage. In addition to this, the questionnaire at fourteen days investigates whether the test subject has changed the adhesive plaster themselves at home. This is an indicator of wound fluid leakage, and thusly, might indicate infection.
Costs	Up to ninety days postoperatively.	Total costs of the suturing method, including costs of the technique itself, time spend in the operating room, and also whether the test subject needs to visit the outpatient clinic visit for a control, or not.; This will be done by assessing the costs of all these separate undertakings in standard care, and then adding the separate costs to the total costs. The theoretical costs will be enquired upon at the departments in the hospital which carry out these actions (i.e. outpatient clinic and operating room management), as well as the financial department of the hospital as a whole, who should be able to access this information.
Number of Visits to a Healthcare Professional	Up to ninety days postoperatively.	Whether or not the participant has visited a healthcare professional postoperatively for wound-related causes. This number of times this occurs per arm will be monitored.

Trial Locations

Locations (1)

Reinier Haga Orthopedisch Centrum; 🇳🇱 Zoetermeer, Zuid Holland, Netherlands