Undermining Apices in Surgical Wounds

NCT ID: NCT05758181

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-09
• Study Completion Date: 2026-03-31

Brief Summary

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.

Detailed Description

Reducing scar tissue formation and postoperative complications in wound closure has remained the focus of recent studies and decreases the cost and time burden of follow-up visits and procedures. Such studies have highlighted the impact of mechanical forces and tension on scar formation, demonstrating that reducing the mechanical stress within the wound environment results in better aesthetic outcomes. Undermining peripheral and apices of the wound has been used in the closure of large and tight defects allowing the closure of these wounds by reducing the tension. Undermining has been shown to reduce tension, and peripheral and apical undermining has been recommended for decreasing scar formation. However, extensive undermining may increase the complications of the surgery by reducing vascularization and creating a space for hematomas. To our knowledge, the impact of scar cosmesis and the rate of postoperative complications in apical undermining in the linear repair of surgical wounds have not been studied, and it remains unknown whether undermining the apices can decrease the protrusion of the scar tissue at the edges. This study seeks to determine the effectiveness of apical undermining of linear wound closures in improving scar cosmesis by using individuals as their own controls in a split-scar model.

This is a single center, randomized, evaluator-blinded, split wound study.

After screening and informed consent, demographic data will be collected including age, race, gender, and medical record number. This will be collected within the Redcap database.

The patient's wound will be labeled A if it is on the left or superior side of the investigator and B if it is on the right or inferior side. A concealed randomization result will be obtained from the Redcap randomization module, which will specify which side, A or B, will receive apical undermining

Following this, both sides of the wound will be sutured together with a subcutaneous (bottom) layer of stitches. Next, a cutaneous layer of sutures will be placed, as is the standard of care. A digital image of the wound after the epidermal closure will be obtained; these may be used in scientific talks and/or for publication purposes. The patient will then be instructed to continue dressing changes along the entire length of the surgical site until the wound is fully healed as is the standard of care.

Treatment assignment, wound length, demographic data, and digital images will be recorded within the Redcap database. Follow-up assessment will be scheduled for three months following the procedure, with a one-month window before or after that time if the patient cannot return at precisely three months.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Linear Wound Closure

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Linear Wound Closure with Apical Undermining

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

Group Type: EXPERIMENTAL

Apical Undermining

Intervention Type: OTHER

The skin at the tip of the wound will be freed to reduce tension.

Interventions

Apical Undermining

The skin at the tip of the wound will be freed to reduce tension.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure on the neck, trunk, and extremities with predicted primary closure
• Willing to return for follow-up visit

Exclusion Criteria

• Incarceration
• Under 18 years of age
• Pregnant women
• Unable to understand written and oral English
• Wounds with predicted closure length less than 3cm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis - Dermatology

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Countries

United States

References

Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.

Reference Type: BACKGROUND

PMID: 21606834 (View on PubMed)

Barnes LA, Marshall CD, Leavitt T, Hu MS, Moore AL, Gonzalez JG, Longaker MT, Gurtner GC. Mechanical Forces in Cutaneous Wound Healing: Emerging Therapies to Minimize Scar Formation. Adv Wound Care (New Rochelle). 2018 Feb 1;7(2):47-56. doi: 10.1089/wound.2016.0709.

Reference Type: BACKGROUND

PMID: 29392093 (View on PubMed)

Krishnan NM, Brown BJ, Davison SP, Mauskar N, Mino M, Jordan MH, Shupp JW. Reducing Wound Tension with Undermining or Imbrication-Do They Work? Plast Reconstr Surg Glob Open. 2016 Jul 13;4(7):e799. doi: 10.1097/GOX.0000000000000799. eCollection 2016 Jul.

Reference Type: BACKGROUND

PMID: 27536478 (View on PubMed)

Zitelli JA. TIPS for a better ellipse. J Am Acad Dermatol. 1990 Jan;22(1):101-3. doi: 10.1016/0190-9622(90)70016-b.

Reference Type: BACKGROUND

PMID: 2405023 (View on PubMed)

Jonathan K (Ed). Dermatologic Surgery. McGraw-Hill Education. 2018. ISBN: 978-1-25-964392-7.

Reference Type: BACKGROUND

Other Identifiers

1999193

Identifier Type: -

Identifier Source: org_study_id