Reepithelialization of Skin Graft Donor SitesNCT01055925
Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel
A study testing modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) and Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing in people with Reepithelialization of Skin Graft Donor Sites, run by Klinik Bogenhausen at 1 site in Germany.
Trial summary
The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reepithelialization of Skin Graft Donor Sites
- What is being tested?
- modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) and Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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
- Adult, Older adult
Who may be able to join
- skin graft donor site anterolateral thigh
- men and women > 18 years
Who cannot join
- informed consent missing
- repeated skin graft take or prior injury at the observed site
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- History of hypersensitivity to the investigational products
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich
Munich, Bavaria, 81925
About this study
The almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.
- Being tested
- modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK), Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK)Device
Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressingDevice
| Study group | Role | What they receive |
|---|---|---|
| MPV | Active comparator | Not described Receives: Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) |
| Aquacel | Active comparator | Not described Receives: Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
reepithelialization rate
Measured: 10th day postoperative
Secondary outcomes (1)
pain, scar formation, complications (e.g. infection), costs
Measured: pain until and during dressing removal, scar formation 60 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reepithelialization of Skin Graft Donor SitesStudies 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Klinik Bogenhausen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055925
- Sponsor's protocol ID
- MPV-AQUACEL
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Trial of a Modified Polyurethane Dressing and Aquacel
- ClinicalTrials.gov ID
- NCT01055925
- Acronym / sponsor ID
- MPV-AQUACEL
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Klinik BogenhausenUniversity, hospital or other
- First posted
- 26 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 almost single disadvantage of conventional polyurethane film dressings, an uncontrolled leakage, is probably as often described as its numerous advantages for split-thickness skin graft (STSG) donor sites. This shortcoming can be overcome by perforating the polyurethane dressing (MPD), which permits a controlled leakage into a secondary absorbent dressing. The study was conducted to compare the MPD-system and Aquacel® (ConvaTec), a hydrofiber wound dressing, which also seems to fulfill all criteria of an ideal donor site dressing.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPV | Active comparator | Device: modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) |
| Aquacel | Active comparator | Device: Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- skin graft donor site anterolateral thigh
- men and women > 18 years
Key exclusion criteria (4 listed)
- informed consent missing
- repeated skin graft take or prior injury at the observed site
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- History of hypersensitivity to the investigational products
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 |
|---|---|---|
| modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) | Device | MPV |
| Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing | Device | Aquacel |
Primary outcome
reepithelialization rate
Time frame: 10th day postoperative
1 secondary outcome
pain, scar formation, complications (e.g. infection), costs
Time frame: pain until and during dressing removal, scar formation 60 days following surgery
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 26 Jan 2010.
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 modified polyurethane film dressing (OpSite, Smith&Nephew, London, UK) and Aquacel® (ConvaTec, Skillman, NJ, USA), sodium carboxy-methylcellulose hydrocolloid polymer dressing in people with Reepithelialization of Skin Graft Donor Sites, run by Klinik Bogenhausen 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 2 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 26 Jan 2010. 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?
reepithelialization rate (time frame: 10th day postoperative). 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 26 Jan 2010.