An interventional study of 6-0 fast absorbing gut suture and 5-0 fast absorbing gut suture in Surgical Wound Cosmesis, sponsored by University of California, Davis. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-01.
Sponsored by University of California, Davis · Not applicable, Interventional, and Other
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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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 242 interventional studies indexed under Surgical Wound.
Browse Surgical Wound studies →University of California, Davis is the lead sponsor of 810 studies on the registry; 142 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6-0 fast absorbing gut used to suture wound
Device: 6-0 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 6-0
Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
Scar Assessment
The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
Time frame: 3 months following the procedure
Width of the Scar
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.
Time frame: 3 months following the procedure
No study locations are listed for this record.
Plan to share: Undecided
Ran from Apr 2016 to primary completion in Mar 2017, 10 months.
Of 99 non-industry interventional studies with no phase under Surgical Wound, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 53. This study's 10 months is below that.
Counting every sponsor, half of 126 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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