NCT07384299

Brief Summary

The goal of this observational study is to learn how an individual's skin type influences the wound healing process and scar formation in Chinese patients undergoing facial dermatologic surgery. The main questions it aims to answer are: How does skin type affect the quality of wound healing after facial surgery? How does skin type affect the formation of hypertrophic scars after facial surgery? Researchers will compare groups of patients with different skin types (classified by the Baumann Skin Type) to see if there are significant differences in their healing outcomes and scar characteristics. Participants in this study will: Receive standard facial dermatologic surgery as part of their clinical care. Have their skin type assessed preoperatively. Undergo scheduled postoperative follow-up assessments at 7 and 90 days to evaluate wound healing and scar development using standardized scales.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 18, 2026

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)

    This scale comprises two separate subscales: the Observer Scar Assessment Scale (completed by the clinician) and the Patient Scar Assessment Scale (completed by the participant). The Observer Scale evaluates six items (vascularity, pigmentation, thickness, relief, pliability, and surface area) on a scale from 1 ("like normal skin") to 10 ("the worst scar imaginable"), with a total score ranging from 6 (best) to 60 (worst). The Patient Scale evaluates six items (pain, itching, color, stiffness, thickness, and irregularity) on a scale from 1 ("no, not at all") to 10 ("yes, very much"), with a total score also ranging from 6 (best) to 60 (worst). For both subscales, a higher score indicates a worse scar quality.

    3-month follow-up

  • modified Stony Brook Scar Evaluation Scale (mSBSES)

    Evaluations were independently performed by two clinicians who were blinded to group allocation. The scale comprises four items: scar width, height, color, and suture marks. Each item is scored from 0 to 2 points, where a score of 2 represents the closest resemblance to normal skin, and 0 represents the worst appearance. The total score ranges from 0 to 8, with a higher score indicating a more ideal scar appearance.

    3-month follow-up

Secondary Outcomes (6)

  • Incidence of Postoperative Edema

    7-day follow-up

  • Incidence of Wound Suppuration

    Assessed by direct clinical examination. Unit: % of participants with the presence of suppuration.

  • Incidence of Peri-wound Erythema

    7-day follow-up

  • Incidence of Wound Tenderness

    7-day follow-up

  • Incidence of Postoperative Hemorrhage

    7-day follow-up

  • +1 more secondary outcomes

Study Arms (2)

Oily Skin

classified as having oily skin according to the Baumann questionnaire

Dry Skin

classified as having dry skin according to the Baumann questionnaire

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients undergoing facial skin surgery to remove benign lesions

You may qualify if:

  • Aged between 14 and 60 years.
  • Clinically and postoperatively pathologically diagnosed with a facial benign tumor (e.g., melanocytic nevus, sebaceous cyst, seborrheic keratosis, etc.) and having undergone standard surgical treatment.
  • Voluntary participation in this study with written informed consent obtained.
  • Commitment to comply with all study protocols and to complete all follow-up visits and data collection procedures.

You may not qualify if:

  • Clinically or postoperatively diagnosed with a facial malignant tumor.
  • Wounds requiring staged excision or planned for secondary intention healing.
  • Surgical site located on or adjacent to the mucosal surface.
  • Known history of allergy to any medications or dressings to be used during or after surgery.
  • Presence of systemic diseases that significantly impair wound healing (e.g., poorly controlled diabetes, immunodeficiency disorders, active infections).
  • Current use of medications affecting wound healing or scar formation (e.g., long-term systemic corticosteroids, immunosuppressants).
  • Pregnancy or lactation.
  • Refusal to provide written informed consent, or anticipated inability to comply with study follow-up and data collection.
  • Concurrent participation in another interventional clinical trial.
  • Any other condition deemed by the investigator as likely to interfere with study results or increase participant risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Not Appicable

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

NevusKeratosis, SeborrheicCystsLipomaCicatrix

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Adipose TissueNeoplasms, Connective and Soft TissueFibrosisPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of the Dermatology Department

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 3, 2026

Study Start

June 15, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations