Tools with Scales for Surgical Scars

Overview

About this study

The purpose of this study is to evaluate the reliability and reproducibility of tools and their correlation with validated scales for post-surgical scars.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult individuals, age 18-55 years
  • Plan to undergo bilateral breast reduction surgery with lollipop incisions or abdominoplasty within 4 weeks
  • Written informed consent from the subject was obtained prior to any study-related procedures
  • General good health, in the opinion of the investigator, and no known current COVID-19 disease
  • Body mass index less than 35 kg/m2
  • Fluent and literate in English or Spanish
  • In the investigator’s opinion, able and willing to follow study instructions and likely to complete all required study visits
  • In the investigator’s opinion, must not have a condition or be in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Exclusion Criteria:

  • Active infection or dermatological condition at the surgical sites
  • History of treatments to the surgical sites such as radiation or surgical treatment
  • History of dermatological disease, scarring, tattoos, pigmentation, or other abnormal dermatological variations in the surgical sites that, in the opinion of the investigator or designee, may interfere with study assessments
  • History of clinically significant medical conditions, including cancer, or presence of current uncontrolled systemic disease or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate
  • History of hypertrophic or keloid scars or dermatological conditions such as cutis laxa that could lead to poor healing or widen scars
  • Preplanned elective surgery or anticipated hospitalization during the study aside from study index surgery
  • History of drug or alcohol abuse within the last 6 months
  • Steroids or other immune modulators known to affect wound healing within 30 days before enrollment in this study
  • Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment in this study
  • Self-reported pregnancy, and not nursing or planning a pregnancy during the study
  • Directly or indirectly involved in the conduct and administration of this study as an investigator, sub‑investigator, or study coordinator, or employee of the sponsor

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/26/2024. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christin Harless, M.D.

Contact us for the latest status

Contact information:

Amy Holst

(507) 266-1155

Holst.Amy@mayo.edu

More information

Publications

Publications are currently not available