Compare Antimicrobial to Conventional Suture in Patients Receiving Primary Total Knee Replacement

NCT02533492 | Completed Phase 4

• 1 other identifier: 98-2933a3
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement is now one of the most popular reconstructive procedures for the elderly people to regain their functional capacity and life quality. However the reported incidence of postoperative infection or surgical site infection after total knee replacement has been around 1 to 2 percent. The cost and expenditure for treating periprosthetic infection are high and the results are often detrimental to the patients who suffered from the complication. To decrease the wound healing complication related to the contamination of bacteria, an antibacterial suture was used successfully in some clinical settings and in animal experiments. Whether the antibacterial suture material could be used in patients with total knee replacement has not been addressed in the past. The investigators therefore propose a prospective randomized double-blinded study to investigate the efficacy of an antibacterial suture material in total knee replacement. The inclusion criteria are patients with degenerative osteoarthritis without previous surgery to the index knee. Patients who have inflammatory arthritis such as rheumatoid arthritis, who have neurovascular disease of the lower extremities, who have history of liver cirrhosis or under hemodialysis for renal failure are excluded. One hundred and two patients will be randomized to study group (51 knees) and control group (51 knees) in a period of 12 months. All cases will follow the standard protocol based on clinical pathway. Antibacterial suture material (Vicryl Plus, Ethicon) will be used in the study group and regular suture material (Vicryl, Ethicon) will be used in the control group. Preoperatively, the skin condition (digital photo and image analysis),laser Doppler study, inflammatory markers (CRP/ESR/IL-6), functional score (KSS: Knee Society Score; SF-12: Short Form 12), and VAS score will be assessed. Operative data of operation time, blood loss and wound classification are recorded. Postoperatively, the skin condition (digital photo and image analysis), skin temperature, inflammatory markers, KSS, and VAS will be assessed on 1st and 3rd postoperative day, 2 weeks, 4 weeks, and 3 months.

Conditions

Wound Infection

Keywords

total knee replacement; vicryl plus; surgical site infection

Outcome Measures

Primary Outcomes (1)

• wound infection

  3 months

Secondary Outcomes (1)

• serum inflammatory marker

  3 months

Other Outcomes (1)

• Physiological parameter (skin temperature)

  3 months

Study Arms (2)

Vicryl

ACTIVE COMPARATOR

Vicryl suture for wound closure after total knee replacement

Device: vicryl

vicryl plus

EXPERIMENTAL

Vicryl plus suture for wound closure after total knee replacement

Device: Vicryl plus

Interventions

vicryl DEVICE

wound closure with vicryl suture

Also known as: polyglactin

Vicryl

Vicryl plus DEVICE

wound closure with vicryl plus suture

Also known as: triclosan-coated polyglactin

vicryl plus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Degenerative osteoarthritis
• Any age
• Varus/valgus deformity knee

You may not qualify if:

• Inflammatory arthritis
• Systemic diseases with coagulopathy
• Immune compromise(ESRD, liver cirrhosis)
• PAOD or DVT history
• Pre-OP INR \>1.5
• ASA score \>3

Sponsors & Collaborators

• Mel Shiuann-Sheng Lee: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kweishan, Taoyuan, 333, Taiwan

Location

Related Publications (2)

• Rozzelle CJ, Leonardo J, Li V. Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial. J Neurosurg Pediatr. 2008 Aug;2(2):111-7. doi: 10.3171/PED/2008/2/8/111.

  PMID: 18671615 BACKGROUND

• Lin SJ, Chang FC, Huang TW, Peng KT, Shih HN, Lee MS. Temporal Change of Interleukin-6, C-Reactive Protein, and Skin Temperature after Total Knee Arthroplasty Using Triclosan-Coated Sutures. Biomed Res Int. 2018 Jan 15;2018:9136208. doi: 10.1155/2018/9136208. eCollection 2018.

  PMID: 29568771 DERIVED

MeSH Terms

Conditions

Wound Infection; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chang Gung Memorial Hospital, Dept Orthopedic Surgery

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: August 26, 2015
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

TW (1)