Surgical WoundNCT05074238
Influence of Sun Protection and Linear Repair of Cutaneous Surgical Defects
A study testing Zinc containing suncreen in people with Surgical Wound and Wound Heal, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Wound Heal, Wound of Skin
- What is being tested?
- Zinc containing suncreen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years of age
- Patient is able to provide informed consent
- Patient is scheduled for a cutaneous excisional surgical procedure
- Cutaneous surgical wound closed via linear repair
- Surgery performed on sunlight-exposed anatomical regions (head, face, neck, hairless scalp)
- Patient is willing to return for follow-up visit to clinic
Who cannot join
- Patient is incarcerated
- Patient is < 18 years of age
- Patient is pregnant
- Patient unwilling to return for 3-month follow-up
- History of reaction to zinc containing sunscreen
- History of collagen vascular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95816
About this study
Official title: Influence of Sun Protection on the Aesthetic Outcomes Following Linear Repair of Cutaneous Surgical Defects, a Randomized Split-Wound Study
The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Half of the wound will be treated with zinc containing sunscreen and the other half of the wound would not be treated. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as a colorimeter to measure the amount of vascularity, and hyperpigmentation between the treated and the non-treated area compared to the 'surrounding skin' defined as skin in the proximity but not adjacent to the wound. Any adverse events will also be recorded.
Read the detailed description
Primary linear repair remains a fundamental and common means of closing skin defects; however, to date, there are no clinical studies currently within the medical literature that explore the potential influence that sunlight exposure has on the cosmetic outcome of surgical site cutaneous scars. Therefore, this study aims to determine the potential effects of sun protection on post-surgical scar cosmesis following linear repairs on sun-exposed areas of the face, hairless scalp, and neck.
It has been thought that sun exposure is associated with a higher chance of erythema and dyspigmentation in cutaneous wounds, however, this remains unproven and findings pertaining to this topic remain largely confined to animal studies. In one study, researchers found that the wounds of rats chronically exposed to UVA radiation exhibited diminished wound contraction during the healing process compared to non-irradiated controls. Another study simulated UV radiation before and after laser treatment on vascular skin lesions in groups of hairless mice. In the postoperative UV-irradiated group, the mice skin displayed significant fibrosis, slower healing, and marked hyperpigmentation. A different group of researchers explored the effect of UVA light exposure on wound pigmentation on scars with and without dry tattooing. This study found that dry tattooing with UVA light exposure demonstrated significant improvement of hypopigmented scars. The researchers of this study hypothesized that the light exposure led to an inflammation-driven hyperpigmentation response. A separate study hypothesized that UV exposure may be beneficial for wound healing by stimulating melanocyte distribution via keratinocyte-melanocyte cross-talk, and thus, preventing hypopigmentation. Irregularity in the pigmentation of healing scars remains a large insecurity of patients and has led to their desire for surgical corrections of these scars. These researchers suggested that UV exposure will promote melanin production, and thus, potentiate a protective effect against further UV damage and wound hypopigmentation.
Skin color changes provide information and clues about certain pathologies, disease progression, and patient response to treatment. Factors such as melanin vascularity contribute to skin color. Historically, this evaluation of skin color has been subjective, however, objective analysis is now possible by means of colorimeters. Cutaneous color changes can be quantified using the standardized CIELAB system, which measures color light intensity, as well as red/green and yellow/blue intensity. Following Mohs micrographic surgery, the colorimeter can be used as an objective measurement to assess scar hyperpigmentation and vascularity.
- Conditions
- Surgical Wound, Wound Heal, Wound of Skin, Scar
- Being tested
- Zinc containing suncreen
- Keywords
- Sun Protection, Cutaneous Surgery, Wound Closure
- Medical subject headings
- Surgical Wound, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc containing suncreenOther
The study participant will be randomized via a randomization tool within the REDCap database as to which half of the wound ("A" or "B") the patient will be asked to apply zinc containing sunscreen for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Sunscreen Application | Experimental | The study participant will be instructed to start applying the sunscreen provided to them to the randomly assigned half of the wound (A or B). Receives: Other: Zinc containing suncreen |
| No Suncreen Application | Experimental | The study participant will be instructed to not apply the sunscreen provided to them to the randomly assigned half of the wound (A or B). Receives: Other: Zinc containing suncreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient observer assessment score (POSAS)
The primary end point will be the two blinded reviewers sum of the component parts of the patient observer assessment score (POSAS).
The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
Measured: 3-12 months
Secondary outcomes (1)
Colorimeter measurement of wound vascularity and hyperpigmentation.
The secondary endpoints will be the measures of wound vascularity and hyperpigmentation. The colorimeter uses the variables L*, a*, and b* as a means of expressing color as a quantifiable number. L* measuring color brightness between 0 to 100 with 0 being total black and 100 being total white. The a* parameter changes from positive values for red to negative values for green for evaluating the degree of erythema and vascularity. The b* parameter changes from positive values for yellow to a negative value for blue. The L* and b* values will calculate the ITA measure, which represents the overall pigmentation of skin color, where a higher ITA corresponds to lighter skin color. Increased pigmentation of the skin will be seen by a rising b* value and a decreasing L* value.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start16 Jul 2021
- Primary completion1 Dec 2024
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial Assignment At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074238
- Sponsor's protocol ID
- 1784449
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sun Protection on the Aesthetic Outcomes Following Linear Repair of Cutaneous Surgical Defects, a Randomized Split-Wound Study
- ClinicalTrials.gov ID
- NCT05074238
- Acronym / sponsor ID
- 1784449
- Conditions
- Surgical Wound, Wound Heal, Wound of Skin, Scar
- Keywords
- Sun Protection, Cutaneous Surgery, Wound Closure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 12 Oct 2021 (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.
The purpose of this study is to determine the potential influence of sun protection on the aesthetic outcome of post-surgical scars following the reconstruction of Mohs micrographic surgery defects via linear repair. This study will be performed as a randomized split-wound study. Half of the wound will be treated with zinc containing sunscreen and the other half of the wound would not be treated. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as a colorimeter to measure the amount of vascularity, and hyperpigmentation between the treated and the non-treated area compared to the 'surrounding skin' defined as skin in the proximity but not adjacent to the wound. Any adverse events will also be recorded.
Detailed description
Primary linear repair remains a fundamental and common means of closing skin defects; however, to date, there are no clinical studies currently within the medical literature that explore the potential influence that sunlight exposure has on the cosmetic outcome of surgical site cutaneous scars. Therefore, this study aims to determine the potential effects of sun protection on post-surgical scar cosmesis following linear repairs on sun-exposed areas of the face, hairless scalp, and neck.
It has been thought that sun exposure is associated with a higher chance of erythema and dyspigmentation in cutaneous wounds, however, this remains unproven and findings pertaining to this topic remain largely confined to animal studies. In one study, researchers found that the wounds of rats chronically exposed to UVA radiation exhibited diminished wound contraction during the healing process compared to non-irradiated controls. Another study simulated UV radiation before and after laser treatment on vascular skin lesions in groups of hairless mice. In the postoperative UV-irradiated group, the mice skin displayed significant fibrosis, slower healing, and marked hyperpigmentation. A different group of researchers explored the effect of UVA light exposure on wound pigmentation on scars with and without dry tattooing. This study found that dry tattooing with UVA light exposure demonstrated significant improvement of hypopigmented scars. The researchers of this study hypothesized that the light exposure led to an inflammation-driven hyperpigmentation response. A separate study hypothesized that UV exposure may be beneficial for wound healing by stimulating melanocyte distribution via keratinocyte-melanocyte cross-talk, and thus, preventing hypopigmentation. Irregularity in the pigmentation of healing scars remains a large insecurity of patients and has led to their desire for surgical corrections of these scars. These researchers suggested that UV exposure will promote melanin production, and thus, potentiate a protective effect against further UV damage and wound hypopigmentation.
Skin color changes provide information and clues about certain pathologies, disease progression, and patient response to treatment. Factors such as melanin vascularity contribute to skin color. Historically, this evaluation of skin color has been subjective, however, objective analysis is now possible by means of colorimeters. Cutaneous color changes can be quantified using the standardized CIELAB system, which measures color light intensity, as well as red/green and yellow/blue intensity. Following Mohs micrographic surgery, the colorimeter can be used as an objective measurement to assess scar hyperpigmentation and vascularity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Factorial Assignment At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
| Arm | Type | Receives |
|---|---|---|
| Sunscreen Application | Experimental | Other: Zinc containing suncreenThe study participant will be instructed to start applying the sunscreen provided to them to the randomly assigned half of the wound (A or B). |
| No Suncreen Application | Experimental | Other: Zinc containing suncreenThe study participant will be instructed to not apply the sunscreen provided to them to the randomly assigned half of the wound (A or B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is ≥ 18 years of age
- Patient is able to provide informed consent
- Patient is scheduled for a cutaneous excisional surgical procedure
- Cutaneous surgical wound closed via linear repair
- Surgery performed on sunlight-exposed anatomical regions (head, face, neck, hairless scalp)
Key exclusion criteria (6 listed)
- Patient is incarcerated
- Patient is < 18 years of age
- Patient is pregnant
- Patient unwilling to return for 3-month follow-up
- History of reaction to zinc containing sunscreen
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 |
|---|---|---|
| Zinc containing suncreenThe study participant will be randomized via a randomization tool within the REDCap database as to which half of the wound ("A" or "B") the patient will be asked to apply zinc containing sunscreen for the duration of the study. | Other | No Suncreen Application, Sunscreen Application |
Primary outcome
Patient observer assessment score (POSAS)
Time frame: 3-12 months
The primary end point will be the two blinded reviewers sum of the component parts of the patient observer assessment score (POSAS). The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.
1 secondary outcome
Colorimeter measurement of wound vascularity and hyperpigmentation.
Time frame: 3-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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 Zinc containing suncreen in people with Surgical Wound and Wound Heal, run by University of California, Davis at 1 site in United States.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient observer assessment score (POSAS) (time frame: 3-12 months). 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 18 Aug 2026.