NCT03330041

Suturing Distance From the Wound Edge, 2 mm vs 5 mm

Completed NA Results posted Last updated 12 May 2021

What this trial tests

NA trial testing Fast absorbing gut suture in Cutaneous Sutures and Scar Cosmesis in 50 participants. Completed in 9 August 2018.

Timeline

3 October 2017

Primary endpoint
9 August 2018

9 August 2018

Quick facts

Lead sponsor	University of California, Davis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	other
Enrollment	50
Start date	3 October 2017
Primary completion	9 August 2018
Estimated completion	9 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Fast absorbing gut suture

Conditions studied

• Cutaneous Sutures and Scar Cosmesis — all drugs for Cutaneous Sutures and Scar Cosmesis →

Sponsor

University of California, Davis

Who can join

18 and older, any sex, with Cutaneous Sutures and Scar Cosmesis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Posas Score Primary · 3 months following procedure

Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin \& 10 representing the most severe scar imaginable.

Group	Value	95% CI
Fast Absorbing Gut Suture Placed 2 mm Apart	10.2	± 4.7
Fast Absorbing Gut Suture Placed 5 mm Apart	11.5	± 6.4

Width of Scar Secondary · 3 months following procedure

A secondary endpoint will include the width of the scar 1 cm from midline on each side. This measurement will be reported in mm

Group	Value	95% CI
Fast Absorbing Gut Suture Placed 2 mm Apart	0.9	± 0.6
Fast Absorbing Gut Suture Placed 5 mm Apart	0.8	± 0.4

Erythema Secondary · 3 months following procedure

If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported

Group	Value	95% CI
Fast Absorbing Gut Suture Placed 2 mm Apart	0
Fast Absorbing Gut Suture Placed 5 mm Apart	0

Sponsor's own description

This study aims to investigate whether the spacing of the interrupted cutaneous sutures affects surgical wound cosmesis on the face and neck. In other words, the investigators would like to determine which of the following yields a more cosmetically appealing scar: many closely approximated sutures or fewer, more widely spaced sutures. The investigators wish to compare the effects of two versus five millimeter spacing between sutures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of Running Cutaneous Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis of the Face and Neck: A Randomized Clinical Trial.
   Sklar LR, Pourang A, Armstrong AW, Dhaliwal SK, et al · · 2019 · cited 15× · PMID 30649154 · DOI 10.1001/jamadermatol.2018.5057