Wound HealingNCT00600457
Modified Polyurethane Film Dressing For Skin Graft Donor Sites
An observational study of Wound Healing, run by Klinik Bogenhausen at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Polyurethane Film
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Sep 2007
- 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
- Adults over age 18 who require skin grafting
Who cannot join
- Individuals under the age of 18.
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
About this study
The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.
- Conditions
- Wound Healing
- Being tested
- Polyurethane Film
- Keywords
- healing time, pain, infection
- Medical subject headings
- Pain, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyurethane FilmDevice
The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Not described Receives: Device: Polyurethane Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncontrolled leakage
Measured: 1-10th day postoperative
Secondary outcomes (3)
pain
Measured: 1-10th day postoperative
infection
Measured: 1-10th day postoperative
epithelization status
Measured: 10th day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startMar 2007
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies 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
- Observational
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Bogenhausen
- Sponsor type
- University, hospital or other
- Investigators
- Ulf Dornseifer, MD, Principal investigator, Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600457
- Sponsor's protocol ID
- MOPS-1
- Status last verified
- Dec 2008
- First submitted
- 23 Jan 2008
- Last updated
- 16 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7. doi: 10.1097/00000637-197906000-00015.
PubMed 396845James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.
PubMed 1098708Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5. doi: 10.1097/00006534-198403000-00028.
PubMed 6701224Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.
PubMed 15269581
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Polyurethane Film Dressing For Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT00600457
- Acronym / sponsor ID
- MOPS-1
- Conditions
- Wound Healing
- Keywords
- healing time, pain, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Klinik BogenhausenUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 25 Jan 2008 (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 determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1 | – | Device: Polyurethane Film |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over age 18 who require skin grafting
Key exclusion criteria (1 listed)
- Individuals under the age of 18.
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 |
|---|---|---|
| Polyurethane FilmThe modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day | Device | A,1 |
Primary outcome
uncontrolled leakage
Time frame: 1-10th day postoperative
3 secondary outcomes
pain
Time frame: 1-10th day postoperative
infection
Time frame: 1-10th day postoperative
epithelization status
Time frame: 10th day postoperative
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 16 Dec 2008.
- Background: PubMed 396845Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7. doi: 10.1097/00000637-197906000-00015.
- Background: PubMed 1098708James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.
- Background: PubMed 6701224Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5. doi: 10.1097/00006534-198403000-00028.
- Background: PubMed 15269581Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.
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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.
Ulf Dornseifer, MD principal investigator
Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich
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, 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 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 16 Dec 2008. 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?
uncontrolled leakage (time frame: 1-10th day postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600457, which also lists 4 linked publications.
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 16 Dec 2008.