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Reconstruction Flaps for Nasal Surgical Wounds RCT

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.
Email 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
Email 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