Wound HealingNCT00428623
Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients
An observational study of Wound Healing and Patient Comfort, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing, Patient Comfort
- What is being tested?
- wound dressing
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to Jan 2006
- Phase
- Observational
- 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
- patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent
Who cannot join
- known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.
- Conditions
- Wound Healing, Patient Comfort
- Being tested
- wound dressing
- Keywords
- Patient comfort, Wound dressings, infection, vascular surgery
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound dressingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startJan 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- torben V Schroeder, prof,dmsc.md, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428623
- Sponsor's protocol ID
- Torben V Schroeder
- Status last verified
- Jan 2007
- First submitted
- 29 Jan 2007
- Last updated
- 30 Jan 2007
- Results posted
- No
Publications
Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
PubMed 40260835
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquacel Compared to Traditional Post Surgical Wound Dressing in Vascular Surgery Patients
- ClinicalTrials.gov ID
- NCT00428623
- Acronym / sponsor ID
- Torben V Schroeder
- Conditions
- Wound Healing, Patient Comfort
- Keywords
- Patient comfort, Wound dressings, infection, vascular surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jan 2006
- First posted
- 30 Jan 2007 (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 study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. Their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.Number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent
Key exclusion criteria (1 listed)
- known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy
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 dressing | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 30 Jan 2007.
- Derived from this study: PubMed 40260835Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
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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.
torben V Schroeder, prof,dmsc.md study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Healing and Patient Comfort, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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 30 Jan 2007. 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 Denmark. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00428623, which also lists 1 linked publication.
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 30 Jan 2007.