Wound InfectionPhase 4Vicryl-PlusNCT02533492
Compare Antimicrobial to Conventional Suture in Patients Receiving Primary Total Knee Replacement
A Phase 4 study testing vicryl and Vicryl plus in people with Wound Infection, run by Mel Shiuann-Sheng Lee at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Infection
- What is being tested?
- vicryl and Vicryl plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Degenerative osteoarthritis
- Any age
- Varus/valgus deformity knee
Who cannot join
- Inflammatory arthritis
- Systemic diseases with coagulopathy
- Immune compromise(ESRD, liver cirrhosis)
- PAOD or DVT history
- Pre-OP INR >1.5
- ASA score >3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compare the Results of Antimicrobial to Conventional Suture Materials in Patients Receiving Primary Total Knee Replacement: A Prospective Double-blinded Randomized Controlled Trial
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.
Read the detailed description
Title of study:
Compare the results of Antimicrobial with Conventional suture materials in patients receiving primary total knee replacement: a prospective double-blinded randomized controlled trial
Objectives:
Primary Objective: To investigate whether the surgical site infection rate after total knee replacement will be different with two different suture materials.
Secondary Objective: To investigate the surrogating markers for inflammatory response and functional outcomes with two different suture materials.
Rationale:
The reported rate of deep infection following contemporary total knee replacement has been about two percent. The prevalence of prolonged wound drainage of soft tissue complications is between 17 to 50% of patients in whom 1.3% of them eventually developed culture-proved prosthetic infection. Total knee infections typically require complete removal of the prosthesis and prolonged antibiotic treatment. Re-infection rate following revision surgery for infected total knee cases is also significantly higher than those without infection complications. Total knee infections are devastating and associated with prolonged hospital stays, increased co-morbidity, and utilization of medical resources. Measures to reduce the infection rate extensively implemented clinically. However the use of antibacterial suture materials to reduce the wound complications has not yet been investigated before. Clinical trials including this issue only had been discussed in animal studies for minimal series. The effectiveness of the new material should be checked.
This study is designed to investigate the wound conditions and deep infection incidence following total knee replacement performed using either antimicrobial or conventional sutures. A prospective, double-blinded, randomized controlled trial with 102 patients evenly distributed into two groups is proposed. Each group has 51 patients scheduled for unilateral total knee replacement. Randomization is by envelope-drawing to minimize confounding risk factors. One hundred and two sets of suture materials (51 sets of Vicryl Plus and 51 sets of Vicryl) will be separately put into sealed envelopes. The envelopes are randomly assigned with consecutive numbers from 1 to 102. The envelopes are randomly given to the patients for wound closure. Finally, one group of patients will receive antibacterial sutures (VICRYL Plus, Ethicon, Johnson and Johnson, Taipei, Taiwan) following total knee replacement for the wound closure and the other group of patients will receive conventional sutures (VICRYL, Ethicon, Johnson and Johnson, Taipei, Taiwan) following total knee replacement for the wound closure. Group sample sizes of 51 and 51 achieve 81% power to detect a difference of -4% between the null hypothesis that both group means are 9.0 and the alternative hypothesis that the mean is 13.0 with estimated group standard deviations of 6.0 and 8.0 and with a significance level (alpha) of 0.05 using a two-sided two-sample t-test. The primary outcome measure is the incidence of prosthetic infection within three months of surgery. The secondary outcome measures include hospital stay, duration of antibiotics use, pain scale (VAS), wound conditions (wound drainage, extent of erythema, local heat, temperature), and serum parameters during hospitalization and within three months after operation.
- Conditions
- Wound Infection
- Being tested
- vicryl, Vicryl plus
- Keywords
- total knee replacement, vicryl plus, surgical site infection
- Medical subject headings
- Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vicrylDevice
Also called polyglactin
wound closure with vicryl suture
Vicryl plusDevice
Also called triclosan-coated polyglactin
wound closure with vicryl plus suture
| Study group | Role | What they receive |
|---|---|---|
| Vicryl | Active comparator | Vicryl suture for wound closure after total knee replacement Receives: Device: vicryl |
| vicryl plus | Experimental | Vicryl plus suture for wound closure after total knee replacement Receives: Device: Vicryl plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
Measured: 3 months
Secondary outcomes (1)
serum inflammatory marker
ESR, CRP, interleukin-6
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mel Shiuann-Sheng Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor-investigator, Mel Shiuann-Sheng Lee, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533492
- Sponsor's protocol ID
- 98-2933a3
- Acronym
- Vicryl-Plus
- Status last verified
- Aug 2015
- First submitted
- 20 Aug 2015
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18671615Lin 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.
PubMed 29568771
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Results of Antimicrobial to Conventional Suture Materials in Patients Receiving Primary Total Knee Replacement: A Prospective Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02533492
- Acronym / sponsor ID
- Vicryl-Plus / 98-2933a3
- Conditions
- Wound Infection
- Keywords
- total knee replacement, vicryl plus, surgical site infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mel Shiuann-Sheng LeeUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Title of study:
Compare the results of Antimicrobial with Conventional suture materials in patients receiving primary total knee replacement: a prospective double-blinded randomized controlled trial
Objectives:
Primary Objective: To investigate whether the surgical site infection rate after total knee replacement will be different with two different suture materials.
Secondary Objective: To investigate the surrogating markers for inflammatory response and functional outcomes with two different suture materials.
Rationale:
The reported rate of deep infection following contemporary total knee replacement has been about two percent. The prevalence of prolonged wound drainage of soft tissue complications is between 17 to 50% of patients in whom 1.3% of them eventually developed culture-proved prosthetic infection. Total knee infections typically require complete removal of the prosthesis and prolonged antibiotic treatment. Re-infection rate following revision surgery for infected total knee cases is also significantly higher than those without infection complications. Total knee infections are devastating and associated with prolonged hospital stays, increased co-morbidity, and utilization of medical resources. Measures to reduce the infection rate extensively implemented clinically. However the use of antibacterial suture materials to reduce the wound complications has not yet been investigated before. Clinical trials including this issue only had been discussed in animal studies for minimal series. The effectiveness of the new material should be checked.
This study is designed to investigate the wound conditions and deep infection incidence following total knee replacement performed using either antimicrobial or conventional sutures. A prospective, double-blinded, randomized controlled trial with 102 patients evenly distributed into two groups is proposed. Each group has 51 patients scheduled for unilateral total knee replacement. Randomization is by envelope-drawing to minimize confounding risk factors. One hundred and two sets of suture materials (51 sets of Vicryl Plus and 51 sets of Vicryl) will be separately put into sealed envelopes. The envelopes are randomly assigned with consecutive numbers from 1 to 102. The envelopes are randomly given to the patients for wound closure. Finally, one group of patients will receive antibacterial sutures (VICRYL Plus, Ethicon, Johnson and Johnson, Taipei, Taiwan) following total knee replacement for the wound closure and the other group of patients will receive conventional sutures (VICRYL, Ethicon, Johnson and Johnson, Taipei, Taiwan) following total knee replacement for the wound closure. Group sample sizes of 51 and 51 achieve 81% power to detect a difference of -4% between the null hypothesis that both group means are 9.0 and the alternative hypothesis that the mean is 13.0 with estimated group standard deviations of 6.0 and 8.0 and with a significance level (alpha) of 0.05 using a two-sided two-sample t-test. The primary outcome measure is the incidence of prosthetic infection within three months of surgery. The secondary outcome measures include hospital stay, duration of antibiotics use, pain scale (VAS), wound conditions (wound drainage, extent of erythema, local heat, temperature), and serum parameters during hospitalization and within three months after operation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl | Active comparator | Device: vicrylVicryl suture for wound closure after total knee replacement |
| vicryl plus | Experimental | Device: Vicryl plusVicryl plus suture for wound closure after total knee replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Degenerative osteoarthritis
- Any age
- Varus/valgus deformity knee
Key exclusion criteria (6 listed)
- Inflammatory arthritis
- Systemic diseases with coagulopathy
- Immune compromise(ESRD, liver cirrhosis)
- PAOD or DVT history
- Pre-OP INR >1.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vicrylAlso: polyglactinwound closure with vicryl suture | Device | Vicryl |
| Vicryl plusAlso: triclosan-coated polyglactinwound closure with vicryl plus suture | Device | vicryl plus |
Primary outcome
wound infection
Time frame: 3 months
1 secondary outcome
serum inflammatory marker
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
- Background: PubMed 18671615Rozzelle 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.
- Derived from this study: PubMed 29568771Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vicryl and Vicryl plus in people with Wound Infection, run by Mel Shiuann-Sheng Lee at 1 site in Taiwan.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound infection (time frame: 3 months). 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 NCT02533492, which also lists 2 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 26 Aug 2015.