Digestive System Diseases [C06]Phase 3NCT00826410
Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
A Phase 3 study testing Redon drain in people with Digestive System Diseases [C06] and Digestive System Neoplasms [C04.588.274], run by University Hospital Freiburg at 1 site in Germany.
Trial summary
The aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Diseases [C06], Digestive System Neoplasms [C04.588.274]
- What is being tested?
- Redon drain
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for laparotomy
- age older 18 years
- informed consent
Who cannot join
- organ transplantation
- operation for abdominal hernia
- appendectomy by McBurney incision
- redo-operation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Visceral and General Surgery , University of Freiburg, Germany
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
The aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery.
Read the detailed description
If subcutan drains inserted during wound closudsure after laparotomy avoid subcutaneous haematoma and seromas by suction, these drains shout protect against surgical site infections. This is the ratio why such drain are in use in many countries. To test whether this hypothesis is true or not we pland this study.
- Being tested
- Redon drain
- Keywords
- Laparotomy, Surgical site infection, Drainage
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Redon drainDevice
Also called subcutaneous suction drain according to Redon
subcutaneous suction drain after laparotomy for two days
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous drain | Experimental | Use of subcutaneus suction drain ("Redon") after laparotomy Receives: Device: Redon drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of surgical site infections according to CDC guidelines after laparotomy in general surgery
Measured: 30 days after operation
Secondary outcomes (1)
risk factors for surgical site infections
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMay 2003
- Primary completionDec 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System Diseases [C06]Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Peter K Baier, MD, Principal investigator, Department of Visceral and General Surgery University of Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826410
- Sponsor's protocol ID
- 230/02
- Status last verified
- Jan 2009
- First submitted
- 20 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Value of Subcutaneous Drains in Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT00826410
- Acronym / sponsor ID
- 230/02
- Keywords
- Laparotomy, Surgical site infection, Drainage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine wether subcutaneus suction drain (type redon-drain) protect against surgical side infection by laparotomy in general surgery.
Detailed description
If subcutan drains inserted during wound closudsure after laparotomy avoid subcutaneous haematoma and seromas by suction, these drains shout protect against surgical site infections. This is the ratio why such drain are in use in many countries. To test whether this hypothesis is true or not we pland this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous drain | Experimental | Device: Redon drainUse of subcutaneus suction drain ("Redon") after laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for laparotomy
- age older 18 years
- informed consent
Key exclusion criteria (4 listed)
- organ transplantation
- operation for abdominal hernia
- appendectomy by McBurney incision
- redo-operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Redon drainAlso: subcutaneous suction drain according to Redonsubcutaneous suction drain after laparotomy for two days | Device | subcutaneous drain |
Primary outcome
number of surgical site infections according to CDC guidelines after laparotomy in general surgery
Time frame: 30 days after operation
1 secondary outcome
risk factors for surgical site infections
Time frame: 30 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter K Baier, MD principal investigator
Department of Visceral and General Surgery University of Freiburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Redon drain in people with Digestive System Diseases [C06] and Digestive System Neoplasms [C04.588.274], run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of surgical site infections according to CDC guidelines after laparotomy in general surgery (time frame: 30 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2009.