- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384299
Impact of Skin Type on Wonud Healing and Scarring Following Facial Skin Surgery
Impact of Baumann Skin Type on Wound Healing and Scar Formation Following Facial Skin Surgery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430022
- Not Appicable
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Oily Skin
classified as having oily skin according to the Baumann questionnaire
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Dry Skin
classified as having dry skin according to the Baumann questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)
Time Frame: 3-month follow-up
|
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
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modified Stony Brook Scar Evaluation Scale (mSBSES)
Time Frame: 3-month follow-up
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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.
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3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Postoperative Edema
Time Frame: 7-day follow-up
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Assessed by direct clinical examination.
Unit: % of participants with the presence of edema.
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7-day follow-up
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Incidence of Wound Suppuration
Time Frame: Assessed by direct clinical examination. Unit: % of participants with the presence of suppuration.
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7-day follow-up
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Assessed by direct clinical examination. Unit: % of participants with the presence of suppuration.
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Incidence of Peri-wound Erythema
Time Frame: 7-day follow-up
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Assessed by direct clinical examination.
Unit: % of participants with the presence of erythema.
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7-day follow-up
|
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Incidence of Wound Tenderness
Time Frame: 7-day follow-up
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Assessed by patient report.
Unit: % of participants reporting tenderness.
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7-day follow-up
|
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Incidence of Postoperative Hemorrhage
Time Frame: 7-day follow-up
|
Assessed by direct clinical examination.
Unit: % of participants with active bleeding or hematoma formation.
|
7-day follow-up
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Incidence of Peri-wound Ecchymosis
Time Frame: 7-day follow-uo
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Assessed by direct clinical examination.
Unit: % of participants with the presence of ecchymosis.
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7-day follow-uo
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Pathological Conditions, Anatomical
- Neoplasms by Histologic Type
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Nevi and Melanomas
- Neoplasms, Adipose Tissue
- Keratosis
- Fibrosis
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Cicatrix
- Cysts
- Nevus
- Lipoma
- Keratosis, Seborrheic
Other Study ID Numbers
- WuhanUH-2025PFKBaumann
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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