Presence of IleostomyDRASTARNCT01050686
Need for Subcutaneous Wound Drains in Ileostomy Reversal
A study testing insertion of subcutaneous wound drain and no insertion of subcutaneous wound drain in people with Presence of Ileostomy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presence of Ileostomy
- What is being tested?
- insertion of subcutaneous wound drain and no insertion of subcutaneous wound drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Feb 2015
- Phase
- Interventional
- 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
- elective open reversal of an protective ileostomy
Who cannot join
- age < 18 years
- missing suitability to comprehend patient information
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Campus Benjamin Franklin; Hindenburgdamm 30
Berlin, State of Berlin, 12200
About this study
The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.
- Conditions
- Presence of Ileostomy
- Being tested
- insertion of subcutaneous wound drain, no insertion of subcutaneous wound drain
- Keywords
- ileostomy reversal, subcutaneous drain, hospital stay, postoperative wound infection, patients with elective ileostomy reversal
- 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.
insertion of subcutaneous wound drainProcedure or surgery
after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted
no insertion of subcutaneous wound drainProcedure or surgery
closure of abdominal wall and skin without insertion of subcutaneous wound drain
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous wound drain | Active comparator | subcutaneous wound drain inserted Receives: Procedure: insertion of subcutaneous wound drain |
| no subcutaneous wound drain | Experimental | no subcutaneous wound drain inserted Receives: Procedure: no insertion of subcutaneous wound drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay (days)
Measured: 3 months postoperatively
Secondary outcomes (7)
surgical site infections
Measured: 3 months postoperatively
colonization of abdominal wall with bacteria
Measured: 3 months postoperativly
hematomas/ seromas
Measured: 3 months postoperatively
postoperative complications
Measured: 3 months postoperatively
postoperative pain/ dysaesthesia
Measured: 3 months postoperatively
cosmetic result
Measured: 3 months postoperatively
postoperative costs
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presence of IleostomyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Lauscher, Charite University, Berlin, Germany
- Investigators
- Johannes C Lauscher, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050686
- Sponsor's protocol ID
- EA4/120/09
- Acronym
- DRASTAR
- Status last verified
- Feb 2015
- First submitted
- 14 Jan 2010
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Need for Subcutaneous Wound Drains in Ileostomy Reversal
- ClinicalTrials.gov ID
- NCT01050686
- Acronym / sponsor ID
- DRASTAR / EA4/120/09
- Conditions
- Presence of Ileostomy
- Keywords
- ileostomy reversal, subcutaneous drain, hospital stay, postoperative wound infection, patients with elective ileostomy reversal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Jan 2010 (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 purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subcutaneous wound drain | Active comparator | Procedure: insertion of subcutaneous wound drainsubcutaneous wound drain inserted |
| no subcutaneous wound drain | Experimental | Procedure: no insertion of subcutaneous wound drainno subcutaneous wound drain inserted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective open reversal of an protective ileostomy
Key exclusion criteria (2 listed)
- age < 18 years
- missing suitability to comprehend patient information
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 |
|---|---|---|
| insertion of subcutaneous wound drainafter the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted | Procedure or surgery | subcutaneous wound drain |
| no insertion of subcutaneous wound drainclosure of abdominal wall and skin without insertion of subcutaneous wound drain | Procedure or surgery | no subcutaneous wound drain |
Primary outcome
length of hospital stay (days)
Time frame: 3 months postoperatively
7 secondary outcomes
surgical site infections
Time frame: 3 months postoperatively
colonization of abdominal wall with bacteria
Time frame: 3 months postoperativly
hematomas/ seromas
Time frame: 3 months postoperatively
postoperative complications
Time frame: 3 months postoperatively
postoperative pain/ dysaesthesia
Time frame: 3 months postoperatively
cosmetic result
Time frame: 3 months postoperatively
postoperative costs
Time frame: 3 months postoperatively
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 12 Feb 2015.
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.
Johannes C Lauscher, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insertion of subcutaneous wound drain and no insertion of subcutaneous wound drain in people with Presence of Ileostomy, run by Charite University, Berlin, Germany 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 1 inclusion and 2 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 12 Feb 2015. 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.
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?
length of hospital stay (days) (time frame: 3 months postoperatively). 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 12 Feb 2015.