Trial document

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DRKS-ID: DRKS00006199

Trial Description

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Title

Postoperative negative pressure incision therapy following open colorectal surgery: a randomized-controlled trial

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Trial Acronym

Poniy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

More than 20% of patients develop surgical site infections following colorectal surgery, which cause substantial morbidity, prolongation of hospital stay, costs and even mortality. A novel negative pressure incision therapy device, which is applied for 5-7 days postoperative, was developed to reduce surgical site infections by continuous removal of wound secretion from the incisional wound. However, the device has not yet been tested in a high-quality trial and its effectiveness is therefore unclear. The Poniy trial will investigate, whether this negative pressure incision therapy device reduces wound infections in comparison to standard wound coverage in patients undergoing open elective colorectal surgery.

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Brief Summary in Scientific Language

The aim of the trial is to investigate whether negative pressure incisional therapy for 5-7 days postoperative significantly reduces postoperative surgical site infections in comparison to standard wound dressings following open elective abdominal surgery.

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Organizational Data

DRKS-ID: DRKS00006199
Date of Registration in DRKS: 2014/08/20
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 155/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München

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Secondary IDs

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Health Condition or Problem studied

Free text: open colorectal surgery

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Interventions/Observational Groups

Arm 1: Postoperative wound coverage with negative pressure incisional therapy device (PrevenaTM Incision Management System) for 5-7 days postoperative.
Arm 2: Postoperative wound coverage with standard dressings for 5-7 days postoperative.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: investigator/therapist, assessor, data analyst
Control: Active control (effective treament of control group)
Purpose: Prevention
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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Primary Outcome

Rate of surgical site infections according to the definition of the Centers for Disease Control and Prevention within 30 days postoperative.

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Secondary Outcome

1.) Length of hospital stay
2.) Rate of reoperations
3.) Rate of antibiotic theray
4.) Duration of postoperative negative pressure incision therapy (intervention arm only)
5.) Wound pain assessed with visual analogue scale
6.) Rate of wound complications other than wound infections
7.) Rate of serious adverse events

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center CHIR-Net, München
Medical Center CHIR-Net, Bamberg
Medical Center CHIR-Net, Ilmtalklinik Pfaffenhofen
Medical Center CHIR-Net, RoMed Klinik Prien am Chiemsee
Medical Center CHIR-Net, Maria-Theresia-Klinik München
Medical Center CHIR-Net, Klinikum Bogenhausen München
Medical Center CHIR-Net, Klinikum St. Elisabeth Straubing GmbH
Medical Center CHIR-Net, Rotkreuzklinikum München
Medical Center CHIR-Net, Kreiskliniken Altötting-Burghausen
Medical Center CHIR-Net, Kreisklinik Ebersberg

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/10/01
Target Sample Size: 340
Monocenter/Multicenter trial: Multicenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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Additional Inclusion Criteria

1.) Planned elective open colorectal surgery via median or transverse laparotomy
2.) Age 18 years or older
3.) Ability to understand the nature and extend of the trial and to sign the written informed consent.

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Exclusion Criteria

1.) Pregnancy or breast-feeding
2.) Median or transverse laparotomy within the last 60 days prior to inclusion into the study.
3.) Planned relaparotomy within 30 days
4.) Laparoscopic or laparoscopic assissted surgery
5.) Patients on preoperative antibiotic treatment

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Addresses

Primary Sponsor
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- Klinikum rechts der Isar,Technische Universität München
- Mr. Dr.med. M.Sc. Andre L. Mihaljevic
- Ismaningerstr. 22
- 81675 München
- Germany
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- Telephone: +498941405145
- Fax: +498941404870
- E-mail: andre.mihaljevic at tum.de
- URL: http://www.chir-net-muenchen.de
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Contact for Scientific Queries
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- Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
- Ms. Dr.med. Rebekka Schirren
- Ismaningerstr. 22
- 81675 München
- Germany
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- Telephone: +498941405138
- Fax: +498941404870
- E-mail: rebekka.schirren at tum.de
- URL: http://www.chir-net-muenchen.de
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Contact for Public Queries
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- Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
- Ms. Dr.med. Rebekka Schirren
- Ismaningerstr. 22
- 81675 München
- Germany
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- Telephone: +498941405138
- Fax: +498941404870
- E-mail: rebekka.schirren at tum.de
- URL: http://www.chir-net-muenchen.de
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Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)
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- KCI Europe
- Mr. Dr. Christian L. Seelandt
- Hagenauer Straße 47
- 65203 Wiesbaden
- Germany
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- Telephone: +49 (0) 611-33544 434
- Fax: +49 (0) 611-33544 30434
- E-mail: ChristianLothar.Seelandt at kci1.com
- URL: http://www.kci1.com
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.