Surgical WoundNCT04729231
Reconstruction Flaps for Nasal Surgical Wounds RCT
A study testing Nasalis Sling Flap and Lobed Transposition Flap in people with Surgical Wound, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction. This is a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Nasalis Sling Flap and Lobed Transposition Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to 1 May 2025
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients >18 years
- Defect located on the nasal tip, infratip, or supratip of the nose
- Longest length of the wound should be no greater than 15mm
- Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Who cannot join
- Active infection
- Age <18
- Investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful)
- Current cigarette smoking
- Patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction.
This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ).
This study was a pilot study designed to determine the feasibility of these procedures.
- Conditions
- Surgical Wound
- Being tested
- Nasalis Sling Flap, Lobed Transposition Flap
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasalis Sling FlapProcedure or surgery
The nasalis sling flap involves alteration of the nasalis muscle to create a myocutaneous pedicle flap that will be used to fill in the wound.
Lobed Transposition FlapProcedure or surgery
Lobed flap reconstruction involves the use of cutaneous tissue located adjacent to the nasal tip to fill in the wound. The flap will undergo a 90-degree arc to approximate the desired position.
| Study group | Role | What they receive |
|---|---|---|
| Nasalis Sling Flap | Active comparator | Not described Receives: Procedure: Nasalis Sling Flap |
| Lobed transposition flap | Active comparator | Not described Receives: Procedure: Lobed Transposition Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
This visual analog scale (VAS) measures outcomes of functionality and appearance with values ranging on a continuum from 0 to 10, and higher scores representing a better outcome.
Measured: 6-16 weeks after the procedure
Surgical Outcome Scale
The Surgical Outcome Scale is a likert agreement scale on surgical outcomes with values ranging from 1 (agree) to 5 (disagree), and lower scores representing a better outcome.
Measured: 6-16 weeks after the procedure
Nasal Obstruction Symptom Evaluation (NOSE) Instrument
The Nasal Obstruction Symptom Evaluation (NOSE) Instrument is a questionnaire of nose functionality. This is a checklist of of problems related to the nose/nasal area with possible answers ranging from "not a problem" to a "severe problem".
Measured: Baseline to 6-16 weeks
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale is a likert scale on nasal appearance and function evaluations with values ranging from 1 (always; very poor; very dissatisfied) to 5 (never; excellent; very satisfied), and higher scores representing a better outcome.
Measured: Baseline to 6-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study startJan 2025 (estimated)
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: Study closed before enrollment could begin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729231
- Sponsor's protocol ID
- STU00211248
- Status last verified
- May 2025
- First submitted
- 25 Jan 2021
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
- ClinicalTrials.gov ID
- NCT04729231
- Acronym / sponsor ID
- STU00211248
- Conditions
- Surgical Wound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study closed before enrollment could begin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 28 Jan 2021 (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.
The purpose of this study is to determine whether there is a significant difference in aesthetic and functional outcomes between nasalis sling flaps and lobed flaps of nasal tip wounds requiring reconstruction.
This is a randomized clinical trial. Approximately 32 participants who are undergoing nasal tip wound reconstruction surgery will be invited to participate and randomized to receive either the nasalis sling repair or the lobed flap repair. Patients will be asked to complete a few questionnaires including a VAS scale, the Surgical Outcomes scale, the NOSE instrument, and the Nasal Appearance and Function Evaluation Questionnaire (NAFEQ).
This study was a pilot study designed to determine the feasibility of these procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasalis Sling Flap | Active comparator | Procedure: Nasalis Sling Flap |
| Lobed transposition flap | Active comparator | Procedure: Lobed Transposition Flap |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients >18 years
- Defect located on the nasal tip, infratip, or supratip of the nose
- Longest length of the wound should be no greater than 15mm
- Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study
Key exclusion criteria (5 listed)
- Active infection
- Age <18
- Investigator judgement that patient is not suitable for randomization (preexisting scars or architecture that would make one repair option less likely to be successful)
- Current cigarette smoking
- Patients that have a disease or are taking medication that would severely impair wound healing in the opinion of the investigator
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 |
|---|---|---|
| Nasalis Sling FlapThe nasalis sling flap involves alteration of the nasalis muscle to create a myocutaneous pedicle flap that will be used to fill in the wound. | Procedure or surgery | Nasalis Sling Flap |
| Lobed Transposition FlapLobed flap reconstruction involves the use of cutaneous tissue located adjacent to the nasal tip to fill in the wound. The flap will undergo a 90-degree arc to approximate the desired position. | Procedure or surgery | Lobed transposition flap |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6-16 weeks after the procedure
This visual analog scale (VAS) measures outcomes of functionality and appearance with values ranging on a continuum from 0 to 10, and higher scores representing a better outcome.
Surgical Outcome Scale
Time frame: 6-16 weeks after the procedure
The Surgical Outcome Scale is a likert agreement scale on surgical outcomes with values ranging from 1 (agree) to 5 (disagree), and lower scores representing a better outcome.
Nasal Obstruction Symptom Evaluation (NOSE) Instrument
Time frame: Baseline to 6-16 weeks
The Nasal Obstruction Symptom Evaluation (NOSE) Instrument is a questionnaire of nose functionality. This is a checklist of of problems related to the nose/nasal area with possible answers ranging from "not a problem" to a "severe problem".
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale
Time frame: Baseline to 6-16 weeks
Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale is a likert scale on nasal appearance and function evaluations with values ranging from 1 (always; very poor; very dissatisfied) to 5 (never; excellent; very satisfied), and higher scores representing a better outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasalis Sling Flap and Lobed Transposition Flap in people with Surgical Wound, run by Northwestern University at 1 site in United States.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 May 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual Analog Scale (VAS) (time frame: 6-16 weeks after the procedure). The study lists 4 primary outcomes in all. 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 6 May 2025.