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Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing (SFD)

Primary Purpose

Suture, Complication, Wound, Wound Complication

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suture spacing for wound closure
Sponsored by
Silver Falls Dermatology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suture, Complication

Eligibility Criteria

30 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Silver Falls DermatologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

10 mm suture spacing

Arm Description

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

Outcomes

Primary Outcome Measures

Change in cosmetic outcome of 5 mm versus 10 mm suture spacing on wound healing
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').

Secondary Outcome Measures

Change in wound complications of 5 mm versus 10 mm suture spacing on wound healing
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.

Full Information

First Posted
September 11, 2017
Last Updated
September 12, 2017
Sponsor
Silver Falls Dermatology
Collaborators
Samaritan Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT03284983
Brief Title
Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing
Acronym
SFD
Official Title
Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
October 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Silver Falls Dermatology
Collaborators
Samaritan Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suture, Complication, Wound, Wound Complication, Wound Dehiscence, Wound of Skin, Surgery, Suture; Complications, Infection or Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10 mm suture spacing
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Suture spacing for wound closure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cosmetic outcome of 5 mm versus 10 mm suture spacing on wound healing
Description
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').
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in wound complications of 5 mm versus 10 mm suture spacing on wound healing
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Lear, MD
Phone
503 362 8385
Email
wlear1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Collin M Blattner, DO
Phone
503 362 8385
Email
collin.blattner@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Lear, MD
Organizational Affiliation
Silver Falls Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silver Falls Dermatology
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angie Tingle, CMA
Email
Atingle@silverfallsderm.net
First Name & Middle Initial & Last Name & Degree
William Lear, MD
First Name & Middle Initial & Last Name & Degree
Collin M Blattner, DO

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25431843
Citation
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;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.
Results Reference
background
PubMed Identifier
21216493
Citation
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.
Results Reference
background
PubMed Identifier
18317050
Citation
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.
Results Reference
background
PubMed Identifier
2143522
Citation
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.
Results Reference
background
PubMed Identifier
25116976
Citation
Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9.
Results Reference
result

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Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

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