Surgical Technique for Scarring

Overseen By Michelle Vy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Under 18, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

When patients have surgery on the neck, trunk, arms, or legs, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to free up the skin around the wound. This procedure is also called "undermining". Some studies have shown that freeing up the skin near the tips of the wound, called the "apices," is helpful for improving the cosmetic outcome of scars. This study will investigate if there are any differences in the appearances of the scar if one tip is undermined and the other is not.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Apical Undermining for scarring?

The research indicates that apical surgery, which includes techniques like Apical Undermining, often results in successful healing, with a high percentage of cases showing complete or incomplete healing (scar tissue) that can be considered successful. This suggests that the treatment may be effective in managing scarring, as incomplete healing with scar tissue is often regarded as a positive outcome. ^{1 2 3 4 5}

How does the treatment Apical Undermining differ from other treatments for scarring?

Apical Undermining is unique because it involves freeing and mobilizing the tissue around a wound to reduce tension and improve healing, which can lead to better cosmetic outcomes and faster recovery compared to other methods that may not address tissue tension as effectively. ^{6 7 8 9 10}

Research Team

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Eligibility Criteria

This trial is for adults over 18 who are scheduled for skin surgery on the neck, trunk, or limbs and can return for follow-up. They must understand English and give consent. Pregnant women, those under 18, prisoners, or with very small wounds (<3cm) cannot join.

Inclusion Criteria

I am scheduled for skin surgery on my neck, trunk, or limbs that will be closed up right away.

Able to give informed consent themselves

Willing to return for follow-up visit

Exclusion Criteria

My wound is expected to close and is less than 3cm long.

Pregnant women

I cannot understand written or spoken English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo surgical wound closure with or without apical undermining

1 day

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and complications

3 months

1 visit (in-person) within a one-month window

Treatment Details

Interventions

• Apical Undermining

Trial Overview The study tests a technique called 'Apical Undermining' to reduce scarring after stitches in surgeries on the neck, trunk, arms or legs. It compares scars when one tip of the wound is undermined (skin freed up) versus not.

Participant Groups

Group I: Linear Wound Closure with Apical Undermining Experimental Treatment 1 Intervention

The other side of the wound will have a cutaneous layer of sutures, as is standard of care, and will receive apical undermining.

Group II: Linear Wound Closure Active Control 1 Intervention

A cutaneous layer of sutures will be placed on one side, as is standard of care.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Incomplete healing (scar tissue) after periapical surgery--radiographic findings 8 to 12 years after treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Scarring of Soft Tissues Following Apical Surgery: Visual Assessment of Outcomes One Year After Intervention Using the Bern and Manchester Scores. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Incision techniques and flap designs for apical surgery in the anterior maxilla. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Periapical surgery in a Norwegian county hospital: follow-up findings of 477 teeth. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Surgical management of endodontic failures: indications and treatment results. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The role of the undermining during circular excision of secondary intention healing. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Depressed scars and soft tissues. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Vertical undermining for the closure of partial thickness surgical defects. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Undermining of the scalp: quantitative effects. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Gliding Brow Lift. [2022]