Colorectal SurgeryREDWILNCT01049971
REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
A study testing wound protector and no wound protector in people with Colorectal Surgery and Wound Infections, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Wound Infections
- What is being tested?
- wound protector and no wound protector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2007to Jan 2011
- 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 laparoscopic colorectal resection with minilaparotomy
Who cannot join
- emergency operation
- patients under 18 years of age
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
Official title: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.
Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.
This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.
- Conditions
- Colorectal Surgery, Wound Infections
- Being tested
- wound protector, no wound protector
- Keywords
- colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound protectorDevice
Also called Vi-Drape (Trademark) wound protector
after minilaparotomy, the wound protector is applied
no wound protectorDevice
use of woven drape instead of wound protector
| Study group | Role | What they receive |
|---|---|---|
| no wound protector | Active comparator | instead of wound protector, a woven drape is applied Receives: Device: no wound protector |
| wound protector | Experimental | after minilaparotomy, wound protector is applied Receives: Device: wound protector |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of wound infections
the total percentage of wound infections within 6 months postoperatively will be analyzed
Measured: 6 months postoperatively
Secondary outcomes (4)
colonialization of abdominal wall with bacteria
a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed
Measured: 6 months postoperatively
postoperative costs
the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed
Measured: 6 months postoperatively
length of hospital stay
the total hospital stay including re-admissions is analyzed
Measured: 6 months postoperatively
cosmetic result
the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively
Measured: 6 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 startDec 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049971
- Sponsor's protocol ID
- EA4/089/07
- Acronym
- REDWIL
- Status last verified
- Dec 2007
- First submitted
- 14 Jan 2010
- Last updated
- 7 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors
- ClinicalTrials.gov ID
- NCT01049971
- Acronym / sponsor ID
- REDWIL / EA4/089/07
- Conditions
- Colorectal Surgery, Wound Infections
- Keywords
- colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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.
Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.
Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.
This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no wound protector | Active comparator | Device: no wound protectorinstead of wound protector, a woven drape is applied |
| wound protector | Experimental | Device: wound protectorafter minilaparotomy, wound protector is applied |
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 laparoscopic colorectal resection with minilaparotomy
Key exclusion criteria (2 listed)
- emergency operation
- patients under 18 years of age
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 |
|---|---|---|
| wound protectorAlso: Vi-Drape (Trademark) wound protectorafter minilaparotomy, the wound protector is applied | Device | wound protector |
| no wound protectoruse of woven drape instead of wound protector | Device | no wound protector |
Primary outcome
percentage of wound infections
Time frame: 6 months postoperatively
the total percentage of wound infections within 6 months postoperatively will be analyzed
4 secondary outcomes
colonialization of abdominal wall with bacteria
Time frame: 6 months postoperatively
postoperative costs
Time frame: 6 months postoperatively
length of hospital stay
Time frame: 6 months postoperatively
cosmetic result
Time frame: 6 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 7 Jul 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound protector and no wound protector in people with Colorectal Surgery and Wound Infections, 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 7 Jul 2011. 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?
percentage of wound infections (time frame: 6 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 7 Jul 2011.