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Completed

NCT Number: NCT04870008

Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm)

It is standard teaching that the top layer of sutures should be placed 3-5mm from the wound edge. However, there is lack of data regarding the most optimal placement of sutures from the wound edge for the best cosmetic outcome. The research team wish to determine if sutures placed closer to the wound edge (2mm) or farther from the wound edge (5mm) makes a difference in the cosmetic outcome of the scar.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95816, United States

About this study

Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer. The deep layer dissolves naturally whereas the top layer may necessitate removal if non-absorbable sutures are used. Given the overall lack of evidence in the literature, the choice of suturing technique is largely dependent on the surgeon's preference.

This study aims to investigate whether the distance of simple cuticular suture placement from the wound edge affects wound cosmesis on the head and neck. In other words, we would like to determine which of the following yields a more cosmetically appealing scar: cuticular sutures placed 2 mm from wound edge or cuticular sutures placed 5mm from wound edge.

Although a Dermatologic surgery textbook states that simple cuticular sutures should be placed 3 mm-5 mm from the wound edge1, there have not been any studies to evaluate the optimal distance from wound edge to achieve the most cosmetically appealing scar.

Overall, there is paucity of data regarding the optimal distance of cuticular suture placement from the wound edge to achieve the most cosmetically appealing scar. The research team hope that the study will provide new insight in cutaneous surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Mentally handicapped
  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Wounds with predicted closure length less than 3 cm

Treatment and study plan

Suture

Procedure

The side of patient's scar that will receive the sutures placed at 2 or 5 mm from wound edge.

Primary outcomes

  1. The score of two blinded reviewers using the patient observer scar assessment score

    Time frame: 3-12 months

    At the follow-up visit, two blinded observers will record their scores independently using the POSAS (Patient and Observer Scar Assessment Scale) instrument. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation). The total score of both scales can be simply calculated by summing up the scores of each of the six items.

  2. The mean scar width using the trace-to-tape method at the assessment visit

    Time frame: 3-12 months

    The trace-to-tape method is an objective outcome measure for linear postoperative scars. Mean scar width in mm.

Secondary outcomes

  1. Any complications from the treatment

    Time frame: 3-12 months

    Occurrence of any complications including: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Aesthetic Outcome of Running Cuticular Suture Distance (2mm vs 5mm) From Wound Edge on the Closure of Linear Wounds on the Head and Neck: a Randomized Evaluator Blinded Split Wound Comparative Effective Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 3, 2021
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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