Studies
| Study First Submitted Date | 2021-01-25 |
| Study First Posted Date | 2021-01-28 |
| Last Update Posted Date | 2023-03-30 |
| Start Month Year | January 2024 |
| Primary Completion Month Year | January 2025 |
| Verification Month Year | March 2023 |
| Verification Date | 2023-03-31 |
| Last Update Posted Date | 2023-03-30 |
Facilities
| Sequence: | 200676153 |
| Name | Northwestern University |
| City | Chicago |
| State | Illinois |
| Zip | 60611 |
| Country | United States |
Facility Contacts
| Sequence: | 28196692 |
| Facility Id | 200676153 |
| Contact Type | primary |
| Name | Alejandra Onate, M.S. |
| onate@northwestern.edu | |
Facility Investigators
| Sequence: | 18386409 |
| Facility Id | 200676153 |
| Role | Principal Investigator |
| Name | Murad Alam, MD |
Conditions
| Sequence: | 52344613 |
| Name | Surgical Wound |
| Downcase Name | surgical wound |
Id Information
| Sequence: | 40282908 |
| Id Source | org_study_id |
| Id Value | STU00211248 |
Countries
| Sequence: | 42703971 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55786728 | Sequence: | 55786729 |
| Group Type | Active Comparator | Group Type | Active Comparator |
| Title | Nasalis Sling Flap | Title | Lobed transposition flap |
Interventions
| Sequence: | 52655666 | Sequence: | 52655667 |
| Intervention Type | Procedure | Intervention Type | Procedure |
| Name | Nasalis Sling Flap | Name | Lobed Transposition Flap |
| Description | 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. | Description | 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. |
Design Outcomes
| Sequence: | 178020074 | Sequence: | 178020075 | Sequence: | 178020076 | Sequence: | 178020077 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Visual Analog Scale (VAS) | Measure | Surgical Outcome Scale | Measure | Nasal Obstruction Symptom Evaluation (NOSE) Instrument | Measure | Nasal Appearance and Function Evaluation Questionnaire (NAFEQ) Scale |
| Time Frame | 6-16 weeks after the procedure | Time Frame | 6-16 weeks after the procedure | Time Frame | Baseline to 6-16 weeks | Time Frame | Baseline to 6-16 weeks |
| Description | 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. | Description | 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. | Description | 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". | Description | 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. |
Browse Conditions
| Sequence: | 194147793 | Sequence: | 194147794 |
| Mesh Term | Surgical Wound | Mesh Term | Wounds and Injuries |
| Downcase Mesh Term | surgical wound | Downcase Mesh Term | wounds and injuries |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48481309 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Northwestern University |
Overall Officials
| Sequence: | 29377472 |
| Role | Principal Investigator |
| Name | Murad Alam, MD |
| Affiliation | Northwestern University |
Central Contacts
| Sequence: | 12052505 |
| Contact Type | primary |
| Name | Alejandra Onate, M.S. |
| Phone | 3126956647 |
| onate@northwestern.edu | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68384984 | Sequence: | 68384985 |
| Design Group Id | 55786728 | Design Group Id | 55786729 |
| Intervention Id | 52655666 | Intervention Id | 52655667 |
Eligibilities
| Sequence: | 30865869 |
| Gender | All |
| Minimum Age | 19 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: 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 Exclusion Criteria: 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 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253970240 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 19 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 4 |
Designs
| Sequence: | 30611684 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | Single |
| Outcomes Assessor Masked | True |
Responsible Parties
| Sequence: | 28978214 |
| Responsible Party Type | Principal Investigator |
| Name | Murad Alam |
| Title | Professor of Dermatology |
| Affiliation | Northwestern University |