NCT00998907

Brief Summary

The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,042

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

2.2 years

First QC Date

October 20, 2009

Last Update Submit

January 17, 2012

Conditions

Wound InfectionIncisional Hernia

Keywords

Open Abdominal SurgeryFascial Closure

Outcome Measures

Primary Outcomes (1)

  • The number of wound infections

    30 days after the operation

Secondary Outcomes (2)

  • The number of incisional hernias.

    6 month

  • The number of incisional hernia- long time follow up

    12 month

Study Arms (2)

PDS II

ACTIVE COMPARATOR

PDS II® loop suture is used for abdominal wall closure

Device: PDS II

PDS plus

EXPERIMENTAL

antibacterial coated "PDS plus" is used for abdominal wall closure

Device: PDS plus

Interventions

PDS plusDEVICE

triclosan-coated polydiaxanon 910 suture materials with antiseptic activity (PDS plus®, Ethicon GmbH, Norderstedt, Germany)

Also known as: PDS plus®
PDS plus
PDS IIDEVICE

polyglactin 910 suture material for abdominal wall closure

PDS II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgical pathologies accessed via midline or transverse abdominal incision
  • primary fascial closure

You may not qualify if:

  • pregnancy
  • age under 18 years
  • open abdominal treatment
  • known hypersensitivity against PDS/Triclosan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,

Homburg/Saar, D-66421, Germany

Location

Related Publications (2)

  • 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.

    PMID: 19231586BACKGROUND

  • Justinger C, Slotta JE, Ningel S, Graber S, Kollmar O, Schilling MK. Surgical-site infection after abdominal wall closure with triclosan-impregnated polydioxanone sutures: results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery. 2013 Sep;154(3):589-95. doi: 10.1016/j.surg.2013.04.011. Epub 2013 Jul 13.

    PMID: 23859304DERIVED

Related Links

MeSH Terms

Conditions

Wound InfectionIncisional Hernia

Condition Hierarchy (Ancestors)

InfectionsHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Christoph Justinger, M.D.

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

    PRINCIPAL INVESTIGATOR

  • Martin K Schilling, M.D., FRCS

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priciple Investigator

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

DE(1)