Wound HealNCT05074212
Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing: Below the Knee
A study testing Factorial Assignment in people with Wound Heal and Wound of Skin, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Wound of Skin
- What is being tested?
- Factorial Assignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 24 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm.
- Willing to return for follow up visit
Who cannot join
- Incarceration
- Under 18 years of age
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Department of Dermatology
Sacramento, California, 95816
About this study
Official title: Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing for Cutaneous Surgical Procedures Performed Below the Knee: a Randomized, Blind Control Trial
The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.
Read the detailed description
When a cutaneous wound is created following Mohs micrographic surgery and standard excisions, a decision is made to either allow the wound to heal by second intention ("leave open") or repair the wound ("close"). The decision may depend on patient characteristics, wound location, wound size or wound characteristics.
When the decision is made to repair the wound, the majority of wounds are reconstructed using two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.
This study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below the knee affects wound cosmesis. In other words, the study team would like to determine which of the following yields a more cosmetically appealing scar: below the knee wound that is closed in a linear fashion or below the knee wound that is left open to heal on its own. The study team also plans to look at quality of life measures via validated surveys and complications.
Randomized control trials comparing these two methods appear to be lacking. A randomized trial looked at second intention healing vs primary simple closure following 4mm or 8mm punch biopsies on the arm, back or thigh1. Besides this study, no other information could be found in the literature on randomized trials comparing linear closure vs second intent for cutaneous wounds below the knee. The study team hopes that this study will provide new insight in cutaneous surgery.
- Conditions
- Wound Heal, Wound of Skin
- Being tested
- Factorial Assignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factorial AssignmentOther
At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
| Study group | Role | What they receive |
|---|---|---|
| Complex Linear Closure | Experimental | The study participant will receive two layers of sutures to close the wound. Receives: Other: Factorial Assignment |
| Second Intention Healing | Experimental | The study participant will not have any sutures placed. Receives: Other: Factorial Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSAS
The primary outcome is the sum of the average components of the Observer portion of the Patient and Observer Scar Assessment Scale (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
Mean Scar Width
Mean scar width will be measured using the trace-to-tape method.
Measured: 3-12 months
Secondary outcomes (2)
Occurrence of Complications
Occurrence of any complications from the treatment including: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma.
Measured: 3-12 months
Quality of Life Measures (DLQI)
The DLQI aim is to measure how much patient's skin problem has affected their life.The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.
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 start10 Jan 2022
- Primary completion6 May 2022
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
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
- NCT05074212
- Sponsor's protocol ID
- 1515109
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2021
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing for Cutaneous Surgical Procedures Performed Below the Knee: a Randomized, Blind Control Trial
- ClinicalTrials.gov ID
- NCT05074212
- Acronym / sponsor ID
- 1515109
- Conditions
- Wound Heal, Wound of Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 24 Sep 2024 (actual)
- 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 whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.
Detailed description
When a cutaneous wound is created following Mohs micrographic surgery and standard excisions, a decision is made to either allow the wound to heal by second intention ("leave open") or repair the wound ("close"). The decision may depend on patient characteristics, wound location, wound size or wound characteristics.
When the decision is made to repair the wound, the majority of wounds are reconstructed using two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.
This study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below the knee affects wound cosmesis. In other words, the study team would like to determine which of the following yields a more cosmetically appealing scar: below the knee wound that is closed in a linear fashion or below the knee wound that is left open to heal on its own. The study team also plans to look at quality of life measures via validated surveys and complications.
Randomized control trials comparing these two methods appear to be lacking. A randomized trial looked at second intention healing vs primary simple closure following 4mm or 8mm punch biopsies on the arm, back or thigh1. Besides this study, no other information could be found in the literature on randomized trials comparing linear closure vs second intent for cutaneous wounds below the knee. The study team hopes that this study will provide new insight in cutaneous surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Linear Closure | Experimental | Other: Factorial AssignmentThe study participant will receive two layers of sutures to close the wound. |
| Second Intention Healing | Experimental | Other: Factorial AssignmentThe study participant will not have any sutures placed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm.
- Willing to return for follow up visit
Key exclusion criteria (3 listed)
- Incarceration
- Under 18 years of age
- Pregnant Women
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 |
|---|---|---|
| Factorial AssignmentAt the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS). | Other | Complex Linear Closure, Second Intention Healing |
Primary outcome
POSAS
Time frame: 3-12 months
The primary outcome is the sum of the average components of the Observer portion of the Patient and Observer Scar Assessment Scale (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.
Mean Scar Width
Time frame: 3-12 months
Mean scar width will be measured using the trace-to-tape method.
2 secondary outcomes
Occurrence of Complications
Time frame: 3-12 months
Quality of Life Measures (DLQI)
Time frame: 3-12 months
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 4 Jun 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 Factorial Assignment in people with Wound Heal and Wound of Skin, 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 4 inclusion and 3 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 4 Jun 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?
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?
POSAS (time frame: 3-12 months). The study lists 2 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 4 Jun 2026.