Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing

Not Applicable

• Conditions: Suture, Complication; Surgery; Suture; Complications, Infection or Inflammation; Wound; Wound Dehiscence; Wound of Skin; Wound Complication
• Interventions: Other: Suture spacing for wound closure

• Registration Number: NCT03284983
• Lead Sponsor: Silver Falls Dermatology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-09-12
• Last Update Submitted: 2017-09-12
• Study First Posted: 2017-09-15
• Last Update Posted: 2017-09-15
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 mm suture spacing	Suture spacing for wound closure	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Silver Falls Dermatology; 🇺🇸 Salem, Oregon, United States