Grafting, SkinNCT00363558
Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples
An observational study of Grafting, Skin and Burn, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Skin graft fixation is essential for the success of its survival. There are several common methods for skin graft fixation including sutures, skin staples and glue. The study objective is to compare between skin graft fixation with staples and glue in burn patients. The study is retrospective. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Grafting, Skin, Burn
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2002to May 2003
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hospitalized patients with 2nd and 3rd degree burns who were operated for debridement and skin grafting
- burn total body surface area 1-50%
Who cannot join
- burn total body surface area> 50%
Trial locations and contacts
1 site in 1 country.
About this study
Skin graft fixation is essential for the success of its survival. There are several common methods for skin graft fixation including sutures, skin staples and glue. The study objective is to compare between skin graft fixation with staples and glue in burn patients. The study is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during 1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The parameters that will be compared are skin graft take, hospitalization length and local infection.
- Conditions
- Grafting, Skin, Burn
- Keywords
- skin graft, fixation, cyanoacrylate glue, skin staples
- Medical subject headings
- Burns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJan 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Grafting, SkinStudies 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
- Observational model
- Natural history
- Time perspective
- Retrospective
- Enrolment
- 44 participants
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Neta Adler, MD, Principal investigator, Rabin Medical Center , Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363558
- Sponsor's protocol ID
- 4133
- Status last verified
- May 2003
- First submitted
- 10 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Publications
Kaplan HY. A quick stapler tie-over fixation for skin grafts. Ann Plast Surg. 1989 Feb;22(2):173-4. doi: 10.1097/00000637-198902000-00015.
PubMed 2660713Zaki I, Scerri L, Millard L. Split skin grafting on severely damaged skin. A technique using absorbable tissue adhesive. J Dermatol Surg Oncol. 1994 Dec;20(12):827-9. doi: 10.1111/j.1524-4725.1994.tb03713.x.
PubMed 7798416Shorr N, Cohen MS, Lessner A. Histoacryl closure of eyelid skin grafts. Ophthalmic Plast Reconstr Surg. 1991;7(3):190-3. doi: 10.1097/00002341-199109000-00007.
PubMed 1911525
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of Skin Grafts in Patients With Burns: Comparison Between Cyanoacrylate Glue and Skin Staples
- ClinicalTrials.gov ID
- NCT00363558
- Acronym / sponsor ID
- 4133
- Conditions
- Grafting, Skin, Burn
- Keywords
- skin graft, fixation, cyanoacrylate glue, skin staples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- May 2003
- First posted
- 15 Aug 2006 (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.
Skin graft fixation is essential for the success of its survival. There are several common methods for skin graft fixation including sutures, skin staples and glue. The study objective is to compare between skin graft fixation with staples and glue in burn patients. The study is retrospective. It Includes 44 patients that were hospitalized in the burn unit, Rabin Medical Center, Israel with 2nd and 3rd degree burns, total body surface area 1-50% during 1/2002-5/2003.All patients were operated for debridement and skin grafting. In 29 patients the skin graft was fixated with staples and in 15 with cyanoacrylate glue (histoacryl). The parameters that will be compared are skin graft take, hospitalization length and local infection.
Study design
- Observational model
- Natural history
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- hospitalized patients with 2nd and 3rd degree burns who were operated for debridement and skin grafting
- burn total body surface area 1-50%
Key exclusion criteria (1 listed)
- burn total body surface area> 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 15 Aug 2006.
- Background: PubMed 2660713Kaplan HY. A quick stapler tie-over fixation for skin grafts. Ann Plast Surg. 1989 Feb;22(2):173-4. doi: 10.1097/00000637-198902000-00015.
- Background: PubMed 7798416Zaki I, Scerri L, Millard L. Split skin grafting on severely damaged skin. A technique using absorbable tissue adhesive. J Dermatol Surg Oncol. 1994 Dec;20(12):827-9. doi: 10.1111/j.1524-4725.1994.tb03713.x.
- Background: PubMed 1911525Shorr N, Cohen MS, Lessner A. Histoacryl closure of eyelid skin grafts. Ophthalmic Plast Reconstr Surg. 1991;7(3):190-3. doi: 10.1097/00002341-199109000-00007.
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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.
Neta Adler, MD principal investigator
Rabin Medical Center , Israel
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 Grafting, Skin and Burn, run by Rabin Medical Center at 1 site in Israel.
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 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 15 Aug 2006. 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 Israel. 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 NCT00363558, which also lists 3 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 15 Aug 2006.