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Surgical WoundCica-ProNCT07749495

Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)

A study testing primary knee replacement and Primary hip replacement. in people with Surgical Wound and Knee Arthroplasty, run by Groupe Hospitalier Diaconesses Croix Saint-Simon.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The choice of skin closure (staples vs. monofilament sutures vs. barbed sutures/adhesive) is critical for wound healing quality in prosthetic surgery (hip and knee). The combination of barbed sutures (e.g., Stratafix) and skin glue (e.g., Dermabond) is promising (superior cosmetic outcome, no suture removal… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
primary knee replacement and Primary hip replacement.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
15 Oct 2026to Dec 2027
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

  • Men and women aged over 18 years
  • Patient who has provided written informed consent in duplicate
  • Patient scheduled for a primary hip or knee prosthesis implantation
  • BMI < 30 kg/m²
  • Non-smoker or smoking cessation for more than 4 weeks
  • Patient able to read and understand French
  • Patient with sufficient cognitive capacity to strictly follow study instructions (completion of the calendar)

Who cannot join

  • Patient expresses opposition to participating in the study
  • Patients under 18 years of age
  • Patient scheduled for prosthesis revision surgery
  • History of osteoarticular or soft-tissue infection
  • Diabetes, cardiovascular disease, immunodeficiency, or immunosuppressive treatment
  • Consumption of drugs, tobacco, or alcohol
Show all 13Show fewer
  • Allergy to nickel (staples) or adhesive
  • History of anxiety disorders (generalized anxiety disorder, panic disorder, specific phobia, agoraphobia, social anxiety, separation anxiety), obsessive compulsive disorder (OCD), or post-traumatic stress disorder (PTSD)
  • Patient unable to read and/or understand French
  • Individuals deprived of liberty by judicial or administrative decision
  • Adults unable to consent or incapable of expressing consent
  • Subjects not affiliated with or not benefiting from a social security scheme
  • Pregnant or breastfeeding women

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Younes KERROUMI, Clinical Research Physician contact

+33144643384

ykerroumi@hopital-dcss.org

About this study

The choice of skin closure (staples vs. monofilament sutures vs. barbed sutures/adhesive) is critical for wound healing quality in prosthetic surgery (hip and knee). The combination of barbed sutures (e.g., Stratafix) and skin glue (e.g., Dermabond) is promising (superior cosmetic outcome, no suture removal, antimicrobial barrier) but has been poorly evaluated prospectively and comparatively in orthopaedics, which justifies this study. The primary objective is to compare the wound healing success rate at two weeks postoperatively between the patient groups. The primary outcome measure is successful wound healing, defined as the absence of wound complications (wound dehiscence, seroma, hematoma, early postoperative infection) during the first two weeks

Being tested
primary knee replacement, Primary hip replacement.
Keywords
Skin Closure in Prosthetic Joint Surgery
Medical subject headings
Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • primary knee replacementProcedure or surgery

    For patients who have undergone knee replacement surgery (K), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group K1) to those closed with staples (Group K2).

  • Primary hip replacement.Procedure or surgery

    For patients who have undergone hip replacement surgery (H), the study compares the success of wound healing in surgical wounds closed with barbed sutures and adhesive (Group H1) to those closed with monofilament sutures (Group H2).

Study groups in NCT07749495
Study groupRoleWhat they receive
Group K1: Knee prosthesis, closed with barbed sutures and skin glue.ExperimentalA group of patients who received a knee prosthesis (K) and whose wound was closed using barbed sutures and skin glue (Group K1).
Receives: Procedure: primary knee replacement
Group K2: Knee prosthesis, closed with staples.Active comparatorA group of patients who received a knee prosthesis (K) and whose wound was closed using staples (Group K2).
Receives: Procedure: primary knee replacement
Group H1: Hip prosthesis, closed with barbed sutures and skin glue.ExperimentalA group of patients who received a hip prosthesis (H) and whose wound was closed with barbed suture and skin glue (group H1).
Receives: Procedure: Primary hip replacement.
Group H2: Hip prosthesis, closed with monofilament suture.Active comparatorA group of patients who received a hip prosthesis (H) and whose wound was closed using monofilament sutures (Group H2).
Receives: Procedure: Primary hip replacement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Successful Wound Healing at 2 Weeks Postoperatively

    Proportion of patients with successful wound healing, defined as the complete absence of wound complications (dehiscence, seroma, hematoma, or early postoperative surgical site infection) during the first 2 postoperative weeks

    Measured: 2 weeks postoperatively

Secondary outcomes (8)

  1. Severity Stage of Wound Complications According to DISH Classification

    Categorization and staging of surgical wound complications (Dehiscence, Infection, Seroma, Haematoma) based on the international Delphi consensus DISH classification scale.

    Measured: 2 weeks postoperatively

  2. Patient-Reported Scar Aesthetic Quality Score

    Assessment of the scar's aesthetic quality completed by the patient using a numerical rating scale from 0 to 100, where 0 represents the worst possible aesthetic outcome and 100 represents the best possible aesthetic outcome. Higher scores indicate greater aesthetic satisfaction.

    Measured: 3 months postoperatively

  3. Change from Baseline in Patient Anxiety Evaluated by Visual Analog Scale (VAS)

    Patient self-reported anxiety level measured on a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10, where 0 represents "no anxiety" and 10 represents "extreme/worst possible anxiety". Higher scores indicate higher levels of anxiety.

    Measured: Change from baseline at Week 1 and Week 2 postoperatively

  4. Number of Unplanned Postoperative Wound-Related Medical Consultations

    Total count of unplanned wound-related medical consultations (at outpatient clinics or emergency departments) per patient, as recorded in the patient follow-up logbook.

    Measured: Through 3 months postoperatively

  5. Direct Surgical Closure Material Cost per Patient

    Direct cost (in Euros, EUR) of surgical wound closure materials (including sutures, staples, and skin glue) per patient.

    Measured: At the time of surgery (Day 0)

  6. Number of Wound-Related Postoperative Phone Calls

    Total count of wound-related telephone calls made by the patient, as recorded in the patient follow-up logbook.

    Measured: Through 3 months postoperatively

  7. Postoperative Wound Care and Complication Management Costs per Patient

    Direct medical costs (in Euros, EUR) for postoperative care, including dressing consumables, home nursing visits, and management of early wound complications per patient.

    Measured: Through 3 months postoperatively

  8. Change from Baseline in Patient Anxiety Evaluated by APAIS-C

    Patient anxiety level evaluated using the modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-C). The anxiety subscale score ranges from 4 (minimum possible score) to 20 (maximum possible score). Higher scores indicate higher levels of anxiety.

    Measured: Change from baseline at Week 1 and Week 2 postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07749495
Sponsor's protocol ID
GHDCSS_RIPH1_ORTHO_3_2025
Other IDs
2025-A02223-46
Acronym
Cica-Pro
Status last verified
Aug 2026
First submitted
18 May 2026
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benkovich V, Abialevich A, Benkovich G. Clinical outcomes of closuring technique in total hip arthroplasty and total knee arthroplasty: A comparative study of staples technique vs triclosan-coated barbed sutures. Rev Esp Cir Ortop Traumatol. 2025 Nov-Dec;69(6):621-626. doi: 10.1016/j.recot.2025.03.006. Epub 2025 Mar 27. English, Spanish.

    PubMed 40157721

  • Russo A, Centola M, Nicodemo A, Masse A. The Use of Barbed Sutures in Total Hip Arthroplasty: A Systematic Review on Clinical-Surgical Outcomes, Costs, and Complications. Healthcare (Basel). 2024 May 23;12(11):1063. doi: 10.3390/healthcare12111063.

    PubMed 38891138

  • Liu T, Tao Y, Zhao R, Hua Y, Feng Z, Zheng Q, Zhang G, Geng L, Fu J, Qian W, Ni M, Wang W. Comparison of the safety and efficacy of three superficial skin closure methods for multi-layer wound closure in total knee arthroplasty: a multicenter, prospective, randomized controlled trial. Arthroplasty. 2024 Sep 11;6(1):51. doi: 10.1186/s42836-024-00271-1.

    PubMed 39261893

  • Khlopas A, Sodhi N, Anis HK, Ehiorobo J, Sultan AA, Mont MA. A Systematic Review of Suture Technologies in Total Knee Arthroplasty. Surg Technol Int. 2019 May 15;34:391-396.

    PubMed 30664226

  • Fillingham YA, Matonick JP, Mendoza V, Parvizi J. Comparing the Water-Tight Closure of Barbed and Conventional Suture Under Static and Dynamic Conditions in an Ex-Vivo Human Knee Arthrotomy Model. Arthroplast Today. 2021 Oct 14;12:1-6. doi: 10.1016/j.artd.2021.08.003. eCollection 2021 Dec.

    PubMed 34703862

  • Ainslie-Garcia MH, Anderson LA, Bloch BV, Board TN, Chen AF, Craigie S, Danker W 3rd, Gunja N, Harty J, Hernandez VH, Lebedeva K, Hameed D, Mont MA, Nunley RM, Parvizi J, Perka C, Piuzzi NS, Rolfson O, Rychlik J, Romanini E, Sanz-Ruiz P, Sierra RJ, Suleiman L, Tsiridis E, Vendittoli PA, Wangen H, Zagra L. Identifying Critical Evidence Gaps in Wound Closure and Incision Management After Total Knee Arthroplasty: Delphi Panel Insights. J Arthroplasty. 2025 Jan;40(1):111-118.e1. doi: 10.1016/j.arth.2024.06.057. Epub 2024 Jul 6.

    PubMed 38972434

Questions about this trial

What is this clinical trial studying?

A study testing primary knee replacement and Primary hip replacement. in people with Surgical Wound and Knee Arthroplasty, run by Groupe Hospitalier Diaconesses Croix Saint-Simon.

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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Younes KERROUMI, Clinical Research Physician (+33144643384, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Successful Wound Healing at 2 Weeks Postoperatively (time frame: 2 weeks postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07749495, which also lists 6 linked publications.

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 6 Aug 2026.

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