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Antiseptic Sutures and Wound Infection

Primary Purpose

Wound Infection

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vicryl plus
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wound Infection focused on measuring Vicryl plus, wound infection, coated suture material, open abdominal surgery, transverse laparotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

PDS II

Vicryl plus

Arm Description

PDS II® loop suture was used for abdominal wall closure

antiseptic coated "Vicryl plus" was used for abdominal wall closure

Outcomes

Primary Outcome Measures

The primary outcome was the number of wound infections.

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2009
Last Updated
June 13, 2012
Sponsor
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT00932503
Brief Title
Antiseptic Sutures and Wound Infection
Official Title
Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Vicryl plus, wound infection, coated suture material, open abdominal surgery, transverse laparotomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
839 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PDS II
Arm Type
No Intervention
Arm Description
PDS II® loop suture was used for abdominal wall closure
Arm Title
Vicryl plus
Arm Type
Active Comparator
Arm Description
antiseptic coated "Vicryl plus" was used for abdominal wall closure
Intervention Type
Device
Intervention Name(s)
Vicryl plus
Other Intervention Name(s)
Vicryl plus®
Intervention Description
triclosan-coated polyglactin 910 suture materials with antiseptic activity (Vicryl plus®, Ethicon GmbH, Norderstedt, Germany)
Primary Outcome Measure Information:
Title
The primary outcome was the number of wound infections.
Time Frame
10 days after demission of patient from hospital
Secondary Outcome Measure Information:
Title
The secondary outcome was the number of incisional hernia
Description
long time follow up analyzing the number of incisional hernia after laparotomy comparing Vicryl plus and PDS II
Time Frame
follow up points: 6 month, 1 year, 2 years and 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Justinger, M.D.
Organizational Affiliation
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin K Schilling, M.D.
Organizational Affiliation
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland, D-66421 Homburg/Saar, Germany
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19231586
Citation
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: Surgery. 2009 Sep;146(3):468.
Results Reference
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Antiseptic Sutures and Wound Infection

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