- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284983
Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing (SFD)
September 12, 2017 updated by: Silver Falls Dermatology
The investigators wish to determine how suture spacing (5 mm vs. 10 mm) affects cosmetic outcome and development of "train tracking" in wounds.
Linear wounds with sutures spaced closer together may not be as cosmetically appealing when compared to those that have larger spacing between sutures.
Suturing closer together constricts blood flow and increases tension that ultimately results in more tissue necrosis and a less appealing outcome.
The investigators also aim to conclude if 5 mm or 10 mm suture spacing results in less complications.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William Lear, MD
- Phone Number: 503 362 8385
- Email: wlear1@gmail.com
Study Contact Backup
- Name: Collin M Blattner, DO
- Phone Number: 503 362 8385
- Email: collin.blattner@gmail.com
Study Locations
-
-
Oregon
-
Salem, Oregon, United States, 97302
- Recruiting
- Silver Falls Dermatology
-
Contact:
- Angie Tingle, CMA
- Email: Atingle@silverfallsderm.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female patients, at least 18 years of age, undergoing surgical excision of biopsy-proven skin cancers on the trunk or extremities at Silver Falls Dermatology & Allergy outpatient clinic in Salem, Oregon. Patients with elliptical excisions with length greater than 4.0 centimeters were included.
Exclusion Criteria:
- Patients with prior scars within 2.5cm of the proposed elliptical excision, failure to comply with wound care instructions or failure to follow up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10 mm suture spacing
The investigators aim to determine how suture spacing affects cosmetic outcome of wound healing.
One side (1/2 of the wound length) was sutured with 10 mm suture spacing
|
The wound was divided in half and sutures were spaced 5mm or 10mm apart depending on side.
The sutures were removed at 2-week follow-up appointment and photographs were taken.
The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cosmetic outcome of 5 mm versus 10 mm suture spacing on wound healing
Time Frame: 6 months
|
The wound was divided in half by placing a single 4-0 Polysorb suture in the midpoint of the wound based on ruler measurement.
Simple interrupted nylon sutures were spaced approximately 5mm or 10mm apart depending on side.
The sutures were then removed at 2-week follow-up appointment.
The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician.
The observer scale consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area), and all items were scored on a scale from 1 ('like normal skin') to 10 ('worst scar imaginable').
The patient scale also includes six items (color, itch, pain, thickness, stiffness, and irregularity) and all items were scored on a similar scale from 1 ('like normal skin') to 10 ('worst scar imaginable').
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in wound complications of 5 mm versus 10 mm suture spacing on wound healing
Time Frame: 2 weeks
|
Wounds were also assessed for complications.
Difficulty removing sutures was assessed by presence of either one of the following: unable to directly visualize suture knot or need to probe into wound to remove suture.
Wound dehiscence was defined as at least a 1mm separation of the wound edge for at least 50% of the length of the wound closure.
Edge necrosis was defined as eschar and necrosis of the wound edge for at least 50% of the wound closure.
Infection was defined as any wound that had redness, pain and exudate.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William Lear, MD, Silver Falls Dermatology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.
- Bloemen MC, van Gerven MS, van der Wal MB, Verhaegen PD, Middelkoop E. An objective device for measuring surface roughness of skin and scars. J Am Acad Dermatol. 2011 Apr;64(4):706-15. doi: 10.1016/j.jaad.2010.03.006. Epub 2011 Jan 8.
- Sagi HC, Papp S, Dipasquale T. The effect of suture pattern and tension on cutaneous blood flow as assessed by laser Doppler flowmetry in a pig model. J Orthop Trauma. 2008 Mar;22(3):171-5. doi: 10.1097/BOT.0b013e318169074c.
- Braverman IM, Keh A, Goldminz D. Correlation of laser Doppler wave patterns with underlying microvascular anatomy. J Invest Dermatol. 1990 Sep;95(3):283-6. doi: 10.1111/1523-1747.ep12484917.
- Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
September 11, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
September 15, 2017
Last Update Submitted That Met QC Criteria
September 12, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB16-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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