HIP-STITCH (Wound Recovery After THA)

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.

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 Overview

• Status: Recruiting
• Conditions: Wound Healing Disturbance of
• Intervention / Treatment: Device: Ethicon Monocryl Smooth Suture; Device: Ethicon Vicryl Rapide Braided Suture; Device: Flexifuze Indermil Topical Skin Adhesive; Device: Dermabond Prineo Skin Closure System; Device: Stryker Zip Skin Closure System

Detailed Description

Background of the study:

With the mean age for a patient receiving a THA being 69.4 years old, a precarious situation is being brought to light. Wound recovery is impaired in elderly patients, and poor wound recovery could result in the prosthesis not being fully functional, which might lead to costly revision surgery. In order to investigate which suturing method causes the least amount of wound recovery, we would like to set up a scientific research trial which test the following thesis; Hypothesis: Monocryl sutures give the highest amount of aberrant wound recovery three days, and fourteen days after primary THA via the anterior approach.

Objective of the study:

The primary objective is to investigate which of the four suturing techniques (Monocryl Smooth Suture, Vicryl Rapide Suture in combination with Indermil Skin Glue, Dermabond Prineo Skin Closure System, Stryker Zip Skin Closure) shows the least amount of aberrant wound recovery within fourteen days postoperatively in patients having undergone a THA via the anterior approach.

The secondary objectives are the occurrence of superficial- and deep wound infections for the four suturing techniques within ninety days postoperatively, as well as the costs of each of the suturing techniques, patient satisfaction scores about the suturing techniques at fourteen days and ninety days postoperatively, occurence of postoperative symptoms which the participant has experienced, whether, or not, the participants think they could have removed the closure system themselves (or have friends/family do it for them) at fourteen days postoperatively, and whether, or not, patients have contacted a healthcare professional for wound-related causes within ninety days.

Study design:

Prospective, randomised clinical trial.

Study population:

All patients eighteen years and older, scheduled to undergo primary THA via the anterior approach, for any indication, at the RHOC.

Intervention:

In this study, four methods of wound closure will be compared to each other. These methods are:

• Monocryl Smooth Suture
• Vicryl Rapide Suture in combination with Indermil Skin Glue
• Dermabond Prineo Skin Closure System
• Stryker Zip Skin Closure

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The burden of participation will consist of completing questionnaires fourteen days postoperatively, and ninety days postoperatively. Too, participating patients will face the additional burden of having a photograph of their wound taken during their outpatient clinic visits. Some patients may not be too fond of this, so this could provide additional mental stress. Furthermore, patients will be confronted with the uncertainty surrounding the randomisation process. Not knowing exactly which suturing technique is going to be used could result in mental stress. An additional risk associated with the participation in this study is the possibility that one or more suturing techniques underperform when compared to the others. There is no direct benefit for the subjects.

Aberrant Wound Recovery:

In this study, aberrant wound recovery will be assessed using a self developed classification model for assessing the wound recovery process in surgical wounds. The wounds will be assessed by looking at a photograph of the wound, or the plaster covering the wound. The photograph will be scored on redness of the skin, wound dehiscence, and wound fluid. An expert group consisting of orthopedic surgeons and nurses specialised in wound recovery have aided in the development of this classification model, and it has been tested for its efficacy.

Quality of the data:

In order to preserve the quality of the collected data, a nurse specialised in wound recovery will assess twenty percent of the photographs in this study using the classification model. This is done to check the validity of the scores of the assessor. If the scores between the nurse specialised in wound recovery and the assessor do not differ too much, quality of the collected data is ensured. If the scores do differ, an assessment can be conducted early on in the study in order to educate the assessor on scoring the wounds. This is all done to ensure the quality of the collected data, despite the fact that the classification model is designed in such a way that it is as objective as possible.

Sample size calculation:

The aforementioned expert group has estimated that aberrant wound recovery (wound leakage or wound dehiscence, or a worrying wound appearance) after THA occurs in thirty percent of the Monocryl group and ten percent of the Stryker Zip Closure (16cm) group, Vicryl Rapide + Indermil Skin Glue group, and Dermabond Prineo Skin Closure (22 cm) group postoperatively.

These numbers require a sample size of 187 participants (rounded off to 47 participants per group), given α = .05 and β = .8. Taking into account a loss to follow-up of twenty percent, a total sample size of 233 participants is calculated to be necessary in conducting this research (rounded off to 59 participants per group, making the total amount 236 participants).

All of the calculations and estimations made above, have been conducted by using Package ''pwr'' in R Statistical software.

Statistical analysis:

Descriptive statistics will be used for demographic and (peri)operative variables.

Nominal, and ordinal data will be presented as number, percentage, median, interquartile range, and as range.

Normally distributed data will be presented as mean, standard deviation and 95% CI.

Data that is not normally distributed will be presented as median, interquartile range and range.

Primary outcomes:

The proportions of aberrant wound recovery will be presented for each group. Furthermore, a univariable logistical regression analysis will be performed with the different suturing techniques as independent variable and presence of aberrant wound recovery as dependent variable. Post hoc direct comparisons between the different techniques will be performed if indicated, with Chi-square tests.

Secondary outcomes:

Wound infections and healthcare visits The number of superficial wound infections, deep wound infections and healthcare visits for wound-related causes will be presented for each group, and differences between the groups will be tested with Chi-square tests.

Costs The mean cost for each technique will be presented, determined by the material costs, time to skin closure in the operating room, whether or not a return visit would be necessary outside of study participation (e.g. to remove sutures) and the mean number of extra healthcare visits.

Patient satisfaction and self-removal of suturing device The satisfaction scores, net promotor score and score for self-removal of the suturing device will be presented for each group as appropriate given whether or not the scores are distributed normally. Differences between the groups will be tested with a one-way ANOVA or Kruskall-Wallis test (for normally or not-normally distributed data, respectively). Post hoc direct comparisons between the different techniques will be performed if indicated, with independent T-tests or Mann-Whitney U tests, respectively.

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brechtje Hesseling, Msc; Phone Number: 003179-2065595; Email: onderzoek@rhoc.nl
• Study Contact Backup: Name: Nina MC Mathijssen, Dr.; Phone Number: 003179-2065595; Email: onderzoek@rhoc.nl

Study Locations

• Netherlands
  • Zuid Holland
    • Zoetermeer, Zuid Holland, Netherlands, 2725NA
      • Recruiting
      • Reinier Haga Orthopedisch Centrum
      • Contact: Brechtje Hesseling, Msc; Phone Number: 003179-2065595; Email: onderzoek@rhoc.nl
      • Contact: Nina MC Mathijssen, Dr.; Phone Number: 003179-2065595; Email: onderzoek@rhoc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Monocryl Smooth Suture; 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.	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.
Active Comparator: Vicryl Rapide + Indermil; 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.	Device: 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.; Device: 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.
Experimental: Dermabond Prineo; 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.	Device: 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.
Experimental: Stryker Zip; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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
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
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
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.

Collaborators and Investigators

• Sponsor: Reinier Haga Orthopedisch Centrum
• Investigators: Principal Investigator: Stephan BW Vehmeijer, Dr., Reinier Haga Orthopedisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Anterior approach; Aberrant wound recovery; Monocryl Smooth Suture; Vicryl Rapide Braided Suture; Indermil Topical Skin Adhesive; Dermabond Prineo Skin Closure System; Stryker Zip Skin Closure System
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: OC-2022-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes