Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01019447
Other study ID # INDV-0909001
Secondary ID
Status Completed
Phase Phase 4
First received November 23, 2009
Last updated June 21, 2011
Start date November 2009
Est. completion date March 2011

Study information

Verified date November 2009
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare conventional polyglactin 910 sutures with triclosan-coated polyglactin 910 antimicrobial sutures for the reduction of surgical site infections and any associated health and economic benefits.


Recruitment information / eligibility

Status Completed
Enrollment 701
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients of different age

- Gender

- Risk factors and procedures candidate for surgical intervention during the period of the study

Exclusion Criteria:

- Patients with an established pre-operative infection at the operative site

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Other:
Vicryl Plus
Triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl Plus)
Vicryl
Polyglactin 910 antimicrobial sutures (Vicryl)

Locations

Country Name City State
Egypt Al-Zeraaein Hospital Cairo
Egypt Cairo University Kasr Al-Aini Hospital Cairo

Sponsors (2)

Lead Sponsor Collaborator
Cairo University Amygate Healthcare

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Signs of Surgical Site Infections (SSI) according to Centers for Disease Control (CDC) criteria 30 days (or 1 year in case of prosthesis) No
Secondary Post-operative hospital stay in days 30 days No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Completed NCT05841576 - Anaesthetic Management Guided by COMET Measurements N/A
Withdrawn NCT05338281 - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Recruiting NCT05966961 - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Recruiting NCT05763602 - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) Phase 4
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Completed NCT06154720 - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting NCT06465901 - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI N/A
Not yet recruiting NCT04820075 - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A