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

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT03303027
Collaborator
(none)
50
2
35.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 6-0 fast absorbing gut suture
  • Device: 5-0 fast absorbing gut suture
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
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.The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
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.
Actual Study Start Date :
Apr 27, 2016
Actual Primary Completion Date :
Mar 21, 2017
Actual Study Completion Date :
Apr 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6-0 fast absorbing gut suture

6-0 fast absorbing gut used to suture wound

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

Experimental: 5-0 fast absorbing gut suture

5-0 fast absorbing gut used to suture wound

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

Outcome Measures

Primary Outcome Measures

  1. Scar Assessment [3 months following the procedure]

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

Secondary Outcome Measures

  1. Width of the Scar [3 months following the procedure]

    The 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Davis

Investigators

  • Principal Investigator: Daniel Eisen, MD, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT03303027
Other Study ID Numbers:
  • 902404
First Posted:
Oct 5, 2017
Last Update Posted:
May 1, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, Davis
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2019