NevusNCT07441538
Optimizing the Timing for Facial Surgical Dressing Removal
A study testing sterile gauze dressing in people with Nevus and Seborrheic Keratosis (SK), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Nevus, Seborrheic Keratosis (SK), Cyst
- What is being tested?
- sterile gauze dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Comparing Early to Standard Wound Dressing Removal After Facial Skin Surgery
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.
Read more
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.
- Conditions
- Nevus, Seborrheic Keratosis (SK), Cyst, Lipoma, Scar
- Being tested
- sterile gauze dressing
- Medical subject headings
- Nevus, Keratosis, Seborrheic, Cysts, Lipoma, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sterile gauze dressingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Edema
Assessed by direct clinical examination. Unit: % of participants with the presence of edema.
Measured: 7-day follow-up
Incidence of Postoperative Wound Suppuration
Assessed by direct clinical examination. Unit: % of participants with the presence of wound suppuration.
Measured: 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.
Measured: 7-day follow-up
Incidence of Postoperative Wound Tenderness
Assessed by direct clinical examination. Unit: % of participants with the presence of wound tenderness.
Measured: 7-day follow-up
Incidence of Postoperative Hemorrhage
Assessed by direct clinical examination. Unit: % of participants with the presence of postoperative hemorrhage.
Measured: 7-day follow-up
Incidence of Postoperative Ecchymosis
Assessed by direct clinical examination. Unit: % of participants with the presence of wound ecchymosis.
Measured: 7-day follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 3-month follow-up
Skindex-16
On the seventh postoperative day, the Skindex-16 dermatology-specific quality of life questionnaire will be used to assess the patient's disease-specific quality of life over the past week. This scale consists of a total of 16 items and provides a comprehensive evaluation of the impact of dermatological conditions on the patient's recent life from three dimensions: emotions, functioning, and symptoms. It is particularly suitable for assessing the quality of life in patients with mild skin lesions.
Measured: 7-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start15 Jun 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441538
- Sponsor's protocol ID
- WuhanUH-2025PFKDressing
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Early to Standard Wound Dressing Removal After Facial Skin Surgery
- ClinicalTrials.gov ID
- NCT07441538
- Acronym / sponsor ID
- WuhanUH-2025PFKDressing
- Conditions
- Nevus, Seborrheic Keratosis (SK), Cyst, Lipoma, Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Exposure | Experimental | Procedure: sterile gauze dressingSix 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. |
| 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. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sterile gauze dressingSix 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 or surgery | Early Exposure |
Primary outcome
Incidence of Postoperative Edema
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of edema.
Incidence of Postoperative Wound Suppuration
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound suppuration.
Incidence of Postoperative Peri-wound Erythema
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of peri-wound erythema.
Incidence of Postoperative Wound Tenderness
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound tenderness.
Incidence of Postoperative Hemorrhage
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of postoperative hemorrhage.
Incidence of Postoperative Ecchymosis
Time frame: 7-day follow-up
Assessed by direct clinical examination. Unit: % of participants with the presence of wound ecchymosis.
3 secondary outcomes
Patient and Observer Scar Assessment Scale version 2.0 (POSAS 2.0)
Time frame: 3-month follow-up
modified Stony Brook Scar Evaluation Scale (mSBSES)
Time frame: 3-month follow-up
Skindex-16
Time frame: 7-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sterile gauze dressing in people with Nevus and Seborrheic Keratosis (SK), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Edema (time frame: 7-day follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.