Efficacy of Antimicrobial Coating Suture Coated Vicryl Plus Compared With Vicryl in Reduced Surgical Site Infection of Dental Implant Surgeries: A Uni-Blind Randomized Clinical Trial Study

Vicryl Plus and Vicryl Sutures in Reduce of Infection in Dental Implant Surgery

Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.

Study Overview

• Status: Completed
• Conditions: Infection, Surgical Site
• Intervention / Treatment: Drug: Vicryl plus

Detailed Description

Patients were divided randomly based on computer randomization list in two groups: In group1, vicryl plus 4-0 (Vicryl Plus Ethicon,Johnson & Johnson Company, Sommerville, NJ) suture was used to close surgical site and Vicryl 4-0 (Vicryl Ethicon,Johnson & Johnson Company, Sommerville, NJ) in group II.

All dental implants were placed through creating subperiosteal flaps. In each group, fresh socket placed dental implants were documented. Patients were visited in 1, 2, 3 and 4 weeks after dental implant surgeries.

Postoperative infection was defined as local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site. If wound dehiscence occurred, it was documented.

Patients were blind about what suture was used.

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Need 3 dental implants at the posterior of the mandible

Exclusion Criteria:

• Diabetic patients
• smoker
• poor oral hygiene

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vicryl plus; In this group, vicryl plus(Triclosan coated) sutures were used to close flaps	Drug: Vicryl plus; Using vicryl sutures which coated with triclosan (antibiotic)
No Intervention: vicryl; In this group, vicryl sutures were used to close flaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of post-operative infection	The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.	In one month
The prevalence of post-operative dehiscence	The number of participants who had relatively or completely open wound	In one month

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: August 31, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: sutures; Surgical Wound Infection; Polyglactin 910
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: IR.SBMU.RIDS.REC.1395.336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No