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NCT04729231 | NOT YET RECRUITING | Surgical Wound

Reconstruction Flaps for Nasal Surgical Wounds RCT
Sponsor:

Northwestern University

Information provided by (Responsible Party):

Murad Alam

Brief 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. 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.

Condition or disease

Surgical Wound

Intervention/treatment

Nasalis Sling Flap

Lobed Transposition Flap

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 32 participants
Masking : SINGLE
Primary Purpose : OTHER
Official Title : A Randomized Controlled Trial Comparing the Functional and Aesthetic Outcomes of Lobed Transposition Flaps vs. Nasalis Sling Flaps in Nasal Tip Reconstruction
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2025-01
Estimated Study Completion Date : 2025-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Reconstruction Flaps for Nasal Surgical Wounds RCT

Location Details

NCT04729231

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611