Antiseptic Sutures and Wound Infection

Wound Infection Clinical Trial

Official title:

Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932503
• Other study ID #: Vicryl plus 1
• Status: Completed
• Phase: N/A
• First received: July 1, 2009
• Last updated: June 13, 2012
• Start date: October 2003
• Est. completion date: October 2007

Study information

• Verified date: June 2012
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.

Description:

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 839
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• surgical pathologies accessed via transverse abdominal incision

• primary fascial closure

Exclusion Criteria:

• pregnancy

• age under 18 years

• open abdominal treatment

• known hypersensitivity agains PDS/Vicryl/Triclosan

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Wound Infection

Intervention

Device:
• Vicryl plus
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)

Locations

Country	Name	City	State
Germany	Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany	Homburg/Saar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Justinger C, Moussavian MR, Schlueter C, Kopp B, Kollmar O, Schilling MK. Antibacterial [corrected] coating of abdominal closure sutures and wound infection. Surgery. 2009 Mar;145(3):330-4. doi: 10.1016/j.surg.2008.11.007. Epub 2009 Jan 25. Erratum in: Su — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was the number of wound infections.		10 days after demission of patient from hospital	No
Secondary	The secondary outcome was the number of incisional hernia	long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II	follow up points: 6 month, 1 year, 2 years and 3 years	No