Undermining Apices in Surgical Wounds

NCT05758181 | Enrolling By Invitation

• 1 other identifier: 1999193
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Scarring

Outcome Measures

Primary Outcomes (1)

• Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  The primary endpoint will be the score of two blinded reviewers independently using the POSAS assessment. 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. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10. All parameters should preferably be compared to normal skin on a comparable anatomic location.

  3 months

Secondary Outcomes (3)

• Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

  3 months

• Width of Scar as measured using Trace-to-Tape Method

  3 months

• Complications or Adverse Events from Treatment

  3 months

Study Arms (2)

Linear Wound Closure

NO INTERVENTION

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

Linear Wound Closure with Apical Undermining

EXPERIMENTAL

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

Other: Apical Undermining

Interventions

Apical Undermining OTHER

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

Linear Wound Closure with Apical Undermining

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

Location

Related Publications (5)

• 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.

  PMID: 21606834 BACKGROUND

• 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.

  PMID: 29392093 BACKGROUND

• 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.

  PMID: 27536478 BACKGROUND

• 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.

  PMID: 2405023 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Eisen, MD

  University of California, Davis - Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Two blinded observers will record their scores independently using the POSAS instrument.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: August 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)