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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a technique to reduce scarring after surgery on the neck, trunk, arms, or legs. It compares two methods of closing surgical cuts: standard stitches and stitches with apical undermining, which involves loosening the skin around the wound's tips to reduce tension. The goal is to determine if this extra step results in better-looking scars. This trial suits individuals scheduled for surgery in these areas and willing to return for a follow-up visit. As an unphased trial, it offers the opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that this surgical technique is safe for reducing scarring?

Research has shown that a surgical technique called apical undermining might improve scar healing by reducing skin tension. However, limited data from human studies confirm its effectiveness and safety. Some studies suggest that loosening the skin around wound edges can result in less noticeable scars.

As this technique remains under investigation, researchers continue to assess its safety and effectiveness. By joining clinical trials like this one, participants help researchers determine if the treatment is safe and beneficial for everyone. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for apical undermining in surgical wound closure because it offers a potentially improved technique for minimizing scarring. Unlike the standard practice of simply stitching wounds closed, this method involves strategically loosening the tissues beneath the skin (apical undermining) to reduce tension at the wound's edges. By potentially decreasing scar formation, this technique could enhance healing outcomes and provide patients with less noticeable scars, addressing a common concern with current surgical procedures.

What evidence suggests that apical undermining is effective for reducing scarring?

This trial will compare two surgical techniques for wound closure. One group will use standard Linear Wound Closure, while the other will use Linear Wound Closure with Apical Undermining. Research has shown that apical undermining, which involves loosening and moving tissue around a wound, might reduce scarring by easing the pull on the skin. This method may improve scar appearance, as some studies suggest that less tension at the wound edges can lead to better cosmetic results. However, few large, well-controlled studies in humans have confirmed its effectiveness. Despite this, experts believe this method could be beneficial, and many patients are interested in any improvements in scarring after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Are You a Good Fit for This Trial?

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

Pregnant women

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

I cannot understand written or spoken English.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05758181

NCT05758181 | Undermining Apices in Surgical Wounds

This study seeks to determine the effectiveness of apical undermining of linear wound closures in improving scar cosmesis by using individuals as their own ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9307554/

Undermining during cutaneous wound closure for ...

Undermining is thought to improve wound outcomes; however, randomized controlled data regarding its efficacy are lacking in humans.

3.

clinicaltrials.ucbraid.org

clinicaltrials.ucbraid.org/trial/NCT05758181

Undermining Apices in Surgical Wounds

This study seeks to determine the effectiveness of apical undermining of linear wound closures in improving scar cosmesis by using ...

4.

withpower.com

withpower.com/trial/phase-surgical-wound-2-2023-5af2f

Surgical Technique for Scarring · Info for Participants

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1748681514001739

Review Updated Scar Management Practical Guidelines

Furthermore, a recent survey indicated that 91% of patients who underwent a routine surgical procedure would value any improvement in scarring. ... There is a ...

6.

researchgate.net

researchgate.net/publication/354744009_Undermining_during_cutaneous_wound_closure_for_wounds_less_than_3_cm_in_diameter_a_randomized_split_wound_comparative_effectiveness_trial

(PDF) Undermining during cutaneous wound closure for ...

Undermining is thought to improve wound outcomes; however, randomized controlled data regarding its efficacy are lacking in humans. The objective of this ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34546436/

Undermining during cutaneous wound closure for ... - PubMed

Undermining is thought to improve wound outcomes; however, randomized controlled data regarding its efficacy are lacking in humans.

8.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00282-1/fulltext

Incisional negative pressure wound therapy for the ...

Some research suggests that negative pressure wound therapy (iNPWT) on primary closed incisional wounds effectively reduces the risk of surgical ...

9.

ctv.veeva.com

ctv.veeva.com/study/undermining-apices-in-surgical-wounds

Undermining Apices in Surgical Wounds - ClinicalTrials.Veeva

Undermining has been shown to reduce tension, and peripheral and apical undermining has been recommended for decreasing scar formation. However, ...