Trial document
DRKS00006199
Trial Description
Title
Postoperative negative pressure incision therapy following open colorectal surgery: a randomized-controlled trial
Trial Acronym
Poniy
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.
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.
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
- DRKS00006199
- 2014/08/20
- [---]*
- yes
- Approved
- 155/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
Secondary IDs
- [---]*
Health Condition or Problem studied
- open colorectal surgery
Interventions/Observational Groups
- Postoperative wound coverage with negative pressure incisional therapy device (PrevenaTM Incision Management System) for 5-7 days postoperative.
- Postoperative wound coverage with standard dressings for 5-7 days postoperative.
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- investigator/therapist, assessor, data analyst
- Active control (effective treament of control group)
- Prevention
- Parallel
- N/A
- N/A
Primary Outcome
Rate of surgical site infections according to the definition of the Centers for Disease Control and Prevention within 30 days postoperative.
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
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
- Medical Center
Recruitment
- Actual
- 2015/10/01
- 340
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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.
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Klinikum rechts der Isar,Technische Universität München
- Mr. Dr.med. M.Sc. Andre L. Mihaljevic
- Ismaningerstr. 22
- 81675 München
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +498941405145
- +498941404870
- andre.mihaljevic at tum.de
- http://www.chir-net-muenchen.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
- Ms. Dr.med. Rebekka Schirren
- Ismaningerstr. 22
- 81675 München
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +498941405138
- +498941404870
- rebekka.schirren at tum.de
- http://www.chir-net-muenchen.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
- Ms. Dr.med. Rebekka Schirren
- Ismaningerstr. 22
- 81675 München
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +498941405138
- +498941404870
- rebekka.schirren at tum.de
- http://www.chir-net-muenchen.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- KCI Europe
- Mr. Dr. Christian L. Seelandt
- Hagenauer Straße 47
- 65203 Wiesbaden
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 (0) 611-33544 434
- +49 (0) 611-33544 30434
- ChristianLothar.Seelandt at kci1.com
- http://www.kci1.com
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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