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6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure

Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03303027
Enrollment
50
Registered
2017-10-05
Start date
2016-04-27
Completion date
2019-04-16
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Cosmesis

Keywords

Cosmesis, Surgical Wound, Fast Absorbing Gut, Linear Cutaneous Wound

Brief summary

Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar. Other surgeons believe that using a thicker size of this stitch reduces the tension on the scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to determine whether the thickness of the fast absorbing gut suture that is used makes a difference in the cosmetic outcome of the scar.

Detailed description

The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model, where half of the wound is repaired with 6-0 fast absorbing gut and the other half is repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured via the patient observer scar assessment scale, a validated scar instrument. The scar width, and adverse events will also be recorded. This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a large diameter, and therefore greater tensile strength. The greater tensile strength would provide better support of the healing scar during the first 5-7 days after surgery and for this reason, could potentially lead to improved scar cosmesis. However, the greater diameter could also lead to track marks that are larger and more visible. Furthermore, fast absorbing gut has a high degree of tissue reactivity to begin with, and it is known that larger diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would provide better scar cosmesis by virtue of its lower tissue reactivity3,4.

Interventions

DEVICE6-0 fast absorbing gut suture

Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0

DEVICE5-0 fast absorbing gut suture

Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Scar Assessment3 months following the procedureThe primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.

Secondary

MeasureTime frameDescription
Width of the Scar3 months following the procedureThe secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026