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Status unknownNCT03284983SFDUpdated Sep 15, 2017

Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

An interventional study of Suture spacing for wound closure in Suture, Complication, Wound and Wound Complication, sponsored by Silver Falls Dermatology. Status unknown at 1 site in United States. Open to participants aged 30 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Silver Falls Dermatology · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
30 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Suture, Complication
  • Wound
  • Wound Complication
  • Wound Dehiscence
  • Wound of Skin
  • Surgery
  • Suture; Complications, Infection or Inflammation
03

Who can participate

Ages eligible
30 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

    Other: Suture spacing for wound closure

Interventions

  • OtherSuture spacing for wound closure

    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.

05

What researchers measure

Primary outcomes

  1. 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').

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 2 weeks

06

Study locations

1 of 1 sites recruiting
  • Silver Falls Dermatology
    Salem, Oregon 97302, United States
    • Angie Tingle, CMA · Contact · Atingle@silverfallsderm.net
    • William Lear, MD · Principal investigator
    • Collin M Blattner, DO · Sub investigator
    Recruiting
07

References and documents

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;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4. PubMed 25431843 ↗
  • 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. PubMed 21216493 ↗
  • 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. PubMed 18317050 ↗
  • 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. PubMed 2143522 ↗
  • Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9. PubMed 25116976 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03284983
Lead sponsor
Silver Falls Dermatology
Collaborators
Samaritan Health Services
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jul 1, 2017
Primary completion
Oct 1, 2017 (estimated)
Completion
Oct 1, 2017 (estimated)
Last update
Sep 15, 2017

Study contacts

William Lear, MD
Contact
wlear1@gmail.com
503 362 8385
Collin M Blattner, DO
Contact
collin.blattner@gmail.com
503 362 8385
William Lear, MD
principal investigator · Silver Falls Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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