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

NCT07749495 | Not Yet Recruiting

• 2 other identifiers: GHDCSS_RIPH1_ORTHO_3_20252025-A02223-46
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief 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, 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

Conditions

Surgical Wound; Knee Arthroplasty; Hip Arthroplasty

Keywords

Skin Closure in Prosthetic Joint Surgery

Outcome Measures

Primary Outcomes (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

  2 weeks postoperatively

Secondary Outcomes (8)

• Severity Stage of Wound Complications According to DISH Classification

  2 weeks postoperatively

• Patient-Reported Scar Aesthetic Quality Score

  3 months postoperatively

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

  Change from baseline at Week 1 and Week 2 postoperatively

• Number of Unplanned Postoperative Wound-Related Medical Consultations

  Through 3 months postoperatively

• Direct Surgical Closure Material Cost per Patient

  At the time of surgery (Day 0)

Study Arms (4)

Group K1: Knee prosthesis, closed with barbed sutures and skin glue.

EXPERIMENTAL

A group of patients who received a knee prosthesis (K) and whose wound was closed using barbed sutures and skin glue (Group K1).

Procedure: primary knee replacement

Group K2: Knee prosthesis, closed with staples.

ACTIVE COMPARATOR

A group of patients who received a knee prosthesis (K) and whose wound was closed using staples (Group K2).

Procedure: primary knee replacement

Group H1: Hip prosthesis, closed with barbed sutures and skin glue.

EXPERIMENTAL

A group of patients who received a hip prosthesis (H) and whose wound was closed with barbed suture and skin glue (group H1).

Procedure: Primary hip replacement.

Group H2: Hip prosthesis, closed with monofilament suture.

ACTIVE COMPARATOR

A group of patients who received a hip prosthesis (H) and whose wound was closed using monofilament sutures (Group H2).

Procedure: Primary hip replacement.

Interventions

primary knee replacement PROCEDURE

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).

Group K1: Knee prosthesis, closed with barbed sutures and skin glue.; Group K2: Knee prosthesis, closed with staples.

Primary hip replacement. PROCEDURE

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).

Group H1: Hip prosthesis, closed with barbed sutures and skin glue.; Group H2: Hip prosthesis, closed with monofilament suture.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Related Publications (6)

• 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.

  PMID: 40157721 BACKGROUND

• 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.

  PMID: 38891138 BACKGROUND

• 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.

  PMID: 39261893 BACKGROUND

• 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.

  PMID: 30664226 BACKGROUND

• 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.

  PMID: 34703862 BACKGROUND

• 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.

  PMID: 38972434 BACKGROUND

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Younes KERROUMI, Clinical Research Physician

CONTACT

+33144643384; ykerroumi@hopital-dcss.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share