Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

NCT ID: NCT03284983

Last Updated: 2017-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Suture spacing for wound closure

Intervention Type OTHER

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.

Interventions

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Suture 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samaritan Health Services

OTHER

Sponsor Role collaborator

Silver Falls Dermatology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Lear, MD

Role: PRINCIPAL_INVESTIGATOR

Silver Falls Dermatology

Locations

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Silver Falls Dermatology

Salem, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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William Lear, MD

Role: CONTACT

503 362 8385

Collin M Blattner, DO

Role: CONTACT

503 362 8385

Facility Contacts

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Angie Tingle, CMA

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25431843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21216493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18317050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2143522 (View on PubMed)

Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9.

Reference Type RESULT
PMID: 25116976 (View on PubMed)

Other Identifiers

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IRB16-051

Identifier Type: -

Identifier Source: org_study_id