HIP-STITCH (Wound Recovery After THA)

Wound Healing Disturbance of Clinical Trial

Official title:

The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06275776
• Other study ID #: OC-2022-005
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: February 2024
• Source: Reinier Haga Orthopedisch Centrum
• Contact: Brechtje Hesseling, Msc
• Phone: 003179-2065595
• Email: onderzoek[@]rhoc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: May 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Wound Healing Disturbance of
• Wounds and Injuries

Intervention

Device:
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Netherlands	Reinier Haga Orthopedisch Centrum	Zoetermeer	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Reinier Haga Orthopedisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Superficial or Deep Wound Infection	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.	Up to ninety days postoperatively
Secondary	Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)	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.	Fourteen and ninety days postoperatively
Secondary	Costs	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.	Up to ninety days postoperatively.
Secondary	Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)	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.	Fourteen days postoperatively
Secondary	Patient reported outcome measure: Number of Participants with Other postoperative symptoms	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.	Fourteen days and ninety days postoperatively
Secondary	Number and Type of Complications	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.	Up to ninety days postoperatively
Secondary	Number of Visits to a Healthcare Professional	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.	Up to ninety days postoperatively.