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

NCT02533492 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-08-26

No results posted yet for this study

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

Interventions

DEVICE

vicryl

wound closure with vicryl suture

DEVICE

Vicryl plus

wound closure with vicryl plus suture

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Taiwan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02533492 on ClinicalTrials.gov