Trial document
DRKS00000390
Trial Description
Title
Prevention of abdominal wound infection:
PROUD-Trial
A randomized controlled trial
Trial Acronym
PROUD-Trial
URL of the Trial
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Brief Summary in Lay Language
Wound infection remain one of the most important comlications after abdominal surgery.
This is an interventional trial to investigate the rates of wound infection within 30 days after midline incision for abdominal surgery using two different materials for abdominal closure:
1. continuous closure using a slowly absorbable material, wich is coated with Triclosan (IRGACARE® MP).
2. continuous closure using a slowly absorbable material, wich is not coated.
Patients with elective midline laparotomy for any reason (except for emergency surgery).
Rates of wound infection are assumes to be the same in both groups.
Brief Summary in Scientific Language
To evaluate possible differences in the frequency of wound infections and wound dehiscence within one month after index operation using two different suture materials (PDS vs. PDS+) for continuous abdominal fascial closure after elective midline laparatomy.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00000390
- 2010/04/27
- [---]*
- yes
- Approved
- S-064/2010, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
Secondary IDs
- U1111-1114-6522
- 01/2010 (KSC Trial Number)
Health Condition or Problem studied
- elective midline laparotomy
Interventions/Observational Groups
- The abdomen will be closed by a continuous, all-layer suture using two loops of slowly absorbable monofilament suture =PDS II plus (coated with triclosan).
- The abdomen will be closed by a continuous, all-layer suture using two loops of slowly absorbable monofilament suture =PDS II
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist, assessor
- Active control (effective treament of control group)
- Treatment
- Parallel
- N/A
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Primary Outcome
Wound infection (deep and superficial according to CDC definition) within 30 days after surgery
Secondary Outcome
Duration of surgery /
Length of incision /
Frequency of wound dehiscence (with or without evisceration) /
Frequency of re-operation due to wound dehiscence /
Postoperative intensive care unit stay /
Postoperative hospital stay /
30 day mortality /
Quality of life (QoL)
Countries of Recruitment
- Germany
Locations of Recruitment
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Recruitment
- Actual
- 2010/04/07
- 1200
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 100 Years
Additional Inclusion Criteria
age >= 18 years/
Patients undergoing elective midline laparatomy /
Informed consent
Exclusion Criteria
Participation in another intervention-trial with interference of intervention and / or outcome of this study /
Impaired mental state or language problems
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinik Heidelberg
- Im Neuenheimer Feld 672
- 69120 Heidelberg
- Germany
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end of 1:1-Block address contact primary-sponsor -
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- Chirurgische Universitätsklinik Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC
- Ms. Colette Dörr-Harim
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 6221 56 6986
- +49 6221 56 6988
- colette.doerr-harim at med.uni-heidelberg.de
- http://www.sdgc.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Chirurgische Universitätsklinik Heidelberg Studienzentrum der Deutschen Gesellschaft für Chirurgie-SDGC
- Ms. Colette Dörr-Harim
- Im Neuenheimer Feld 110
- 69120 Heidelberg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 6221 56 6986
- +49 6221 56 6988
- colette.doerr-harim at med.uni-heidelberg.de
- http://www.sdgc.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- ETHICON UK, a division of JOHNSON & JOHNSON MEDICAL LIMITED Kirkton Campus Scotland
- P.O. Box 1988
- EH54 0AB Livingston EH54 0AB
- United Kingdom
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end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
- 2012/11/18
Trial Publications, Results and other Documents
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