Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

Surgery Clinical Trial

— SFD  

Official title:

Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03284983
• Other study ID #: IRB16-051
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2017
• Last updated: September 12, 2017
• Start date: July 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: September 2017
• Source: Silver Falls Dermatology
• Contact: William Lear, MD
• Phone: 503 362 8385
• Email: wlear1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Surgery
• Suture, Complication
• Suture; Complications, Infection or Inflammation
• Wound
• Wound Complication
• Wound Dehiscence
• Wound of Skin
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Silver Falls Dermatology	Salem	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Silver Falls Dermatology	Samaritan Health Services

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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;(11):CD004287. doi: 10.1002/14651858.CD004287.pub4. Review. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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').	6 months
Secondary	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.	2 weeks