Burn ScarNCT03544697
Easy Way of Choosing Rectangular Expander and Getting Maximum Benefit From Expanded Tissue
An observational study of Burn Scar and Scalp Wound, run by Izmir Katip Celebi University.
Trial summary
Background: Tissue expanders are widely used for reconstruction of tissue defects. The choice of expander and planning the flap is complicated for the inexperienced surgeon. Objective: To demonstrate the choice of expander sizes proper for the tissue defect and maximum advancement technique during the defect coverage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Scar, Scalp Wound
- What is being tested?
- Skin expansion and repair with flaps
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2018
- 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
Study population: The present study included 19 patients who were operated using one rectangular expander between January 2013 and January 2017.
Who may be able to join
- Patients treated with rectangular tissue expanders.
- Patients who attended to at least postoperative six months control.
Who cannot join
- Patients treated with tissue expanders other than rectangular expanders.
- Patients who did not attend to postoperative controls.
About this study
Background: Tissue expanders are widely used for reconstruction of tissue defects. The choice of expander and planning the flap is complicated for the inexperienced surgeon.
Objective: To demonstrate the choice of expander sizes proper for the tissue defect and maximum advancement technique during the defect coverage.
Methods: The present study included 19 patients who were operated between January 2013 and January 2017. The expander projection was chosen in the manner that it would be more than the half length of the defect to be occurred and the expander width was chosen as wide as possible based on the area of its placement. After the expansion was completed, advancement method was used to cover the defect.
- Conditions
- Burn Scar, Scalp Wound
- Being tested
- Skin expansion and repair with flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin expansion and repair with flapsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Skin expansion and repair with flaps | The tissue expander was inserted into the scalp in 17 patients and supraclavicular area in two patients. Receives: Procedure: Skin expansion and repair with flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar revision
Closure of defect
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study startJan 2013
- Primary completionJan 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Burn ScarStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersin Aksam, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544697
- Sponsor's protocol ID
- IzmirKCU-Plastik1
- Status last verified
- May 2018
- First submitted
- 21 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NEUMANN CG. The expansion of an area of skin by progressive distention of a subcutaneous balloon; use of the method for securing skin for subtotal reconstruction of the ear. Plast Reconstr Surg (1946). 1957 Feb;19(2):124-30. doi: 10.1097/00006534-195702000-00004. No abstract available.
PubMed 13419574Radovan C. Breast reconstruction after mastectomy using the temporary expander. Plast Reconstr Surg. 1982 Feb;69(2):195-208. doi: 10.1097/00006534-198202000-00001.
PubMed 7054790Pamplona DC, Velloso RQ, Radwanski HN. On skin expansion. J Mech Behav Biomed Mater. 2014 Jan;29:655-62. doi: 10.1016/j.jmbbm.2013.03.023. Epub 2013 Apr 19.
PubMed 23651568Radovan C. Tissue expansion in soft-tissue reconstruction. Plast Reconstr Surg. 1984 Oct;74(4):482-92. doi: 10.1097/00006534-198410000-00005.
PubMed 6484035Manders EK, Schenden MJ, Furrey JA, Hetzler PT, Davis TS, Graham WP 3rd. Soft-tissue expansion: concepts and complications. Plast Reconstr Surg. 1984 Oct;74(4):493-507. doi: 10.1097/00006534-198410000-00007.
PubMed 6484036Hudson DA. Maximising the use of tissue expanded flaps. Br J Plast Surg. 2003 Dec;56(8):784-90. doi: 10.1016/s0007-1226(03)00379-5.
PubMed 14615253Pamplona DC, Weber HI, Leta FR. Optimization of the use of skin expanders. Skin Res Technol. 2014 Nov;20(4):463-72. doi: 10.1111/srt.12141. Epub 2014 Feb 17.
PubMed 24527999Kiyokawa K, Rikimaru H, Inoue Y, Tai Y. A new concept and technique for reconstructing skin defects in the cheek region: an unfolded cube advancement flap. Plast Reconstr Surg. 2004 Mar;113(3):985-91. doi: 10.1097/01.prs.0000105045.57704.44. No abstract available.
PubMed 15108895Ueda K, Hara M, Okada M, Kurokawa N, Otani K, Nuri T. Lambda incision for effective tissue expansion. J Plast Reconstr Aesthet Surg. 2010 Oct;63(10):1682-7. doi: 10.1016/j.bjps.2009.09.015. Epub 2009 Nov 11.
PubMed 19906567Yenidunya MO. The bi-lobed flap design on expanded skin of the face and neck region. Plast Reconstr Surg. 1998 May;101(6):1741-2. doi: 10.1097/00006534-199805000-00066. No abstract available.
PubMed 9583521
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Easy Way of Choosing Rectangular Expander and Getting Maximum Benefit From Expanded Tissue
- ClinicalTrials.gov ID
- NCT03544697
- Acronym / sponsor ID
- IzmirKCU-Plastik1
- Conditions
- Burn Scar, Scalp Wound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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.
Background: Tissue expanders are widely used for reconstruction of tissue defects. The choice of expander and planning the flap is complicated for the inexperienced surgeon.
Objective: To demonstrate the choice of expander sizes proper for the tissue defect and maximum advancement technique during the defect coverage.
Methods: The present study included 19 patients who were operated between January 2013 and January 2017. The expander projection was chosen in the manner that it would be more than the half length of the defect to be occurred and the expander width was chosen as wide as possible based on the area of its placement. After the expansion was completed, advancement method was used to cover the defect.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin expansion and repair with flaps | – | Procedure: Skin expansion and repair with flapsThe tissue expander was inserted into the scalp in 17 patients and supraclavicular area in two patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The present study included 19 patients who were operated using one rectangular expander between January 2013 and January 2017.
Key inclusion criteria (2 listed)
- Patients treated with rectangular tissue expanders.
- Patients who attended to at least postoperative six months control.
Key exclusion criteria (2 listed)
- Patients treated with tissue expanders other than rectangular expanders.
- Patients who did not attend to postoperative controls.
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 |
|---|---|---|
| Skin expansion and repair with flaps | Procedure or surgery | Skin expansion and repair with flaps |
Primary outcome
Scar revision
Time frame: 6 months
Closure of defect
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 4 Jun 2018.
- Background: PubMed 13419574NEUMANN CG. The expansion of an area of skin by progressive distention of a subcutaneous balloon; use of the method for securing skin for subtotal reconstruction of the ear. Plast Reconstr Surg (1946). 1957 Feb;19(2):124-30. doi: 10.1097/00006534-195702000-00004. No abstract available.
- Background: PubMed 7054790Radovan C. Breast reconstruction after mastectomy using the temporary expander. Plast Reconstr Surg. 1982 Feb;69(2):195-208. doi: 10.1097/00006534-198202000-00001.
- Background: PubMed 23651568Pamplona DC, Velloso RQ, Radwanski HN. On skin expansion. J Mech Behav Biomed Mater. 2014 Jan;29:655-62. doi: 10.1016/j.jmbbm.2013.03.023. Epub 2013 Apr 19.
- Background: PubMed 6484035Radovan C. Tissue expansion in soft-tissue reconstruction. Plast Reconstr Surg. 1984 Oct;74(4):482-92. doi: 10.1097/00006534-198410000-00005.
- Background: PubMed 6484036Manders EK, Schenden MJ, Furrey JA, Hetzler PT, Davis TS, Graham WP 3rd. Soft-tissue expansion: concepts and complications. Plast Reconstr Surg. 1984 Oct;74(4):493-507. doi: 10.1097/00006534-198410000-00007.
- Background: PubMed 14615253Hudson DA. Maximising the use of tissue expanded flaps. Br J Plast Surg. 2003 Dec;56(8):784-90. doi: 10.1016/s0007-1226(03)00379-5.
- Background: PubMed 24527999Pamplona DC, Weber HI, Leta FR. Optimization of the use of skin expanders. Skin Res Technol. 2014 Nov;20(4):463-72. doi: 10.1111/srt.12141. Epub 2014 Feb 17.
- Background: PubMed 15108895Kiyokawa K, Rikimaru H, Inoue Y, Tai Y. A new concept and technique for reconstructing skin defects in the cheek region: an unfolded cube advancement flap. Plast Reconstr Surg. 2004 Mar;113(3):985-91. doi: 10.1097/01.prs.0000105045.57704.44. No abstract available.
- Background: PubMed 19906567Ueda K, Hara M, Okada M, Kurokawa N, Otani K, Nuri T. Lambda incision for effective tissue expansion. J Plast Reconstr Aesthet Surg. 2010 Oct;63(10):1682-7. doi: 10.1016/j.bjps.2009.09.015. Epub 2009 Nov 11.
- Background: PubMed 9583521Yenidunya MO. The bi-lobed flap design on expanded skin of the face and neck region. Plast Reconstr Surg. 1998 May;101(6):1741-2. doi: 10.1097/00006534-199805000-00066. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Scar and Scalp Wound, run by Izmir Katip Celebi University.
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 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 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Scar revision (time frame: 6 months). 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 NCT03544697, which also lists 10 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 4 Jun 2018.