NCT07441538

Brief Summary

What is this study about? You are being invited to participate in a clinical research study because you are scheduled to undergo a facial skin surgery for your health condition. Your surgeon will perform your operation independently, and your standard surgical procedure and follow-up visits will not be changed in any way by this study. The purpose of this research is to understand which postoperative care method is more beneficial for facial wound healing and for reducing scar formation. We aim to compare two common approaches for caring for the wound after surgery. Your participation will help doctors choose better care plans for future patients. What will happen in this study? If you agree to participate, you will be randomly assigned (like drawing lots) to one of two groups: Group A (Early Exposure Group): About 6 hours after your surgery, the doctor will remove the sterile gauze covering your wound. After this, you will need to keep the wound area clean and dry, and you will not use a gauze dressing to cover it. Group B (Continuous Coverage Group): After surgery, your wound will continue to be covered with sterile gauze. The doctor or nurse will change the dressing for you regularly until the sutures are removed around 7 days after surgery, or until it is decided to stop based on how the wound is healing. What will I need to do differently? Apart from the assigned wound care method described above, participating in this study involves only the following additions to your regular care: Before Surgery: You will be asked to fill out a simple questionnaire about your skin and undergo a quick, non-invasive skin measurement. During Follow-up Visits: You will be asked to fill out questionnaires and allow the study doctor to take photographs of your surgical area. These photos will be used only for analysis and record-keeping in this study. Your total time commitment for these extra activities is minimal. Participation is entirely voluntary, and your decision will not affect the quality of your medical care. Key Information: Your surgeon decides your operation. This study only involves postoperative wound care. Random Assignment: You cannot choose your group; it is decided randomly by a computer. Privacy: Your personal information and study data (including photos) will be kept strictly confidential and used only for this research. Potential Benefit: You may not benefit directly, but your participation will contribute to medical knowledge. Potential Risks: The risks are considered minimal and are similar to those of standard wound care. The study doctor will monitor your healing closely. You will receive a detailed informed consent form with more information. Please discuss any questions you have with the research team before deciding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

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
1 month until next milestone

First Submitted

Initial submission to the registry

February 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 24, 2026

Last Update Submit

March 2, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Incidence of Postoperative Edema

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

    7-day follow-up

  • Incidence of Postoperative Wound Suppuration

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

    7-day follow-up

  • Incidence of Postoperative Peri-wound Erythema

    Assessed by direct clinical examination. Unit: % of participants with the presence of peri-wound erythema.

    7-day follow-up

  • Incidence of Postoperative Wound Tenderness

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

    7-day follow-up

  • Incidence of Postoperative Hemorrhage

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

    7-day follow-up

  • Incidence of Postoperative Ecchymosis

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

    7-day follow-up

Secondary Outcomes (3)

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

    3-month follow-up

  • modified Stony Brook Scar Evaluation Scale (mSBSES)

    3-month follow-up

  • Skindex-16

    7-day follow-up

Study Arms (2)

Early Exposure

EXPERIMENTAL

Six hours after surgery, the sterile gauze dressing covering the surgical area will be removed. From then on, the wound will be disinfected once daily using a 0.5% povidone-iodine solution. The wound should be kept clean and dry, with no further dressing coverage or application of other topical medications, until the sutures are removed on the seventh postoperative day.

Procedure: sterile gauze dressing

Continuous Coverage

NO INTERVENTION

On the second postoperative day, remove the initial dressing, disinfect the wound with 0.5% povidone-iodine solution (without using other topical medications), and then cover it with a sterile gauze dressing. Thereafter, repeat the dressing change every 48 hours-meaning the wound should remain continuously covered-until the sutures are removed on the seventh postoperative day.

Interventions

Six hours after surgery, the sterile gauze dressing covering the surgical area will be removed. From then on, the wound will be disinfected once daily using a 0.5% povidone-iodine solution. The wound should be kept clean and dry, with no further dressing coverage or application of other topical medications, until the sutures are removed on the seventh postoperative day.

Early Exposure

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged between 18 and 60 years
  • Clinically and postoperatively pathologically diagnosed with a benign facial lesion (e.g., melanocytic nevus, sebaceous cyst, seborrheic keratosis, etc.) and having undergone standard surgical treatment
  • Voluntarily agree to participate in this study and sign a written informed consent form
  • Commit to complying with all study procedures and cooperate to complete all follow-up visits and data collection

You may not qualify if:

  • Clinically or postoperatively pathologically diagnosed with a malignant facial tumor
  • Wounds requiring staged excision or planned for secondary intention healing
  • Surgical site located on or immediately adjacent to a mucosal surface
  • Known history of allergy to surgical gauze dressings or related materials
  • Presence of systemic diseases that significantly impair wound healing (e.g., poorly controlled diabetes, immunodeficiency disorders, active infection, etc.)
  • Concurrent use of medications known to affect wound healing or scar formation (e.g., long-term use of glucocorticoids, immunosuppressants, etc.)
  • Pregnant or lactating women
  • Refusal to sign the informed consent form, or are anticipated to have difficulty complying with study follow-up and data collection
  • Concurrent participation in another interventional clinical trial
  • Any other factors deemed by the investigator as likely to interfere with the study results or increase the participant's 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
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 2, 2026

Study Start

June 15, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations