Wound Healing Disturbance ofNCT06275776
HIP-STITCH (Wound Recovery After THA)
A study testing Ethicon Monocryl Smooth Suture, Ethicon Vicryl Rapide Braided Suture and Flexifuze Indermil Topical Skin Adhesive in people with Wound Healing Disturbance of, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing Disturbance of
- What is being tested?
- Ethicon Monocryl Smooth Suture, Ethicon Vicryl Rapide Braided Suture and Flexifuze Indermil Topical Skin Adhesive
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Aug 2024to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Reinier Haga Orthopedisch Centrum
Zoetermeer, South Holland, 2725NA
Brechtje Hesseling, Msc, 003179-2065595, onderzoek@rhoc.nl
Nina MC Mathijssen, Dr., 003179-2065595, onderzoek@rhoc.nl
About this study
Official title: The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty
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.
Read more
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
- Being tested
- Ethicon Monocryl Smooth Suture, Ethicon Vicryl Rapide Braided Suture, Flexifuze Indermil Topical Skin Adhesive, Dermabond Prineo Skin Closure System, Stryker Zip Skin Closure System
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethicon Monocryl Smooth SutureDevice
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 SutureDevice
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 AdhesiveDevice
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 SystemDevice
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 SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Stryker Zip Skin Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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''.
Measured: Up to fourteen days postoperatively
Secondary outcomes (7)
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.
Measured: Up to ninety days postoperatively
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.
Measured: Fourteen and ninety days postoperatively
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.
Measured: Up to ninety days postoperatively.
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.
Measured: Fourteen days postoperatively
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.
Measured: Fourteen days and ninety days postoperatively
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.
Measured: Up to ninety days postoperatively
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.
Measured: Up to ninety days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start28 Aug 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing Disturbance ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinier Haga Orthopedisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan BW Vehmeijer, Dr., Principal investigator, Reinier Haga Orthopedisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275776
- Sponsor's protocol ID
- OC-2022-005
- Status last verified
- Oct 2024
- First submitted
- 5 Feb 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suturing Techniques on Aberrant Wound Recovery After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06275776
- Acronym / sponsor ID
- OC-2022-005
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Reinier Haga Orthopedisch CentrumUniversity, hospital or other
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Monocryl Smooth Suture | Active comparator | Device: Ethicon Monocryl Smooth SutureStudy 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. |
| Vicryl Rapide + Indermil | Active comparator | Device: Ethicon Vicryl Rapide Braided Suture, Device: Flexifuze Indermil Topical Skin AdhesiveStudy 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. |
| Dermabond Prineo | Experimental | Device: Dermabond Prineo Skin Closure SystemStudy 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. |
| Stryker Zip | Experimental | Device: Stryker Zip Skin Closure SystemStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethicon Monocryl Smooth SutureMonocryl Smooth Suture 3-0 antibacterial with PS-2 needle. Monofilament suture, placed subcutaneously to approximate the superficial wound edges. Currently used in standard care. | Device | Monocryl Smooth Suture |
| Ethicon Vicryl Rapide Braided SutureVicryl Rapide Braided Suture 3-0 with FS-2 needle. Multifilament suture, placed subcutaneously to approximate the superficial wound edges. Currently used in standard care. | Device | Vicryl Rapide + Indermil |
| Flexifuze Indermil Topical Skin AdhesiveFlexifuze 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. | Device | Vicryl Rapide + Indermil |
| Dermabond Prineo Skin Closure SystemDermabond 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. | Device | Dermabond Prineo |
| Stryker Zip Skin Closure SystemStryker 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. | Device | Stryker Zip |
Primary outcome
Number of Participants with Aberrant Wound Recovery
Time frame: 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''.
7 secondary outcomes
Number of Participants with Superficial or Deep Wound Infection
Time frame: Up to ninety days postoperatively
Patient reported outcome measure: Satisfaction scores suturing method (Questionnaire)
Time frame: Fourteen and ninety days postoperatively
Costs
Time frame: Up to ninety days postoperatively.
Patient reported outcome measure: Score of Self-removal of the suturing technique (Questionnaire)
Time frame: Fourteen days postoperatively
Patient reported outcome measure: Number of Participants with Other postoperative symptoms
Time frame: Fourteen days and ninety days postoperatively
Number and Type of Complications
Time frame: Up to ninety days postoperatively
Number of Visits to a Healthcare Professional
Time frame: Up to ninety days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan BW Vehmeijer, Dr. principal investigator
Reinier Haga Orthopedisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethicon Monocryl Smooth Suture, Ethicon Vicryl Rapide Braided Suture and Flexifuze Indermil Topical Skin Adhesive in people with Wound Healing Disturbance of, run by Reinier Haga Orthopedisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brechtje Hesseling, Msc (003179-2065595, onderzoek@rhoc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Aberrant Wound Recovery (time frame: Up to fourteen days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.