Evaluation of Purse-String Closure Vs Second Intention

Not Applicable

Completed

• Conditions: Wound Closure Techniques
• Interventions: Procedure: Purse-String; Procedure: Second Intent

• Registration Number: NCT02062866
• Lead Sponsor: University of California, Davis

Brief Summary

To compare healing time, scar size, aesthetic outcome, and complication rates following second intention healing or purse string closure of surgical wounds on the trunk or extremities. This study, will allow surgeons to make informed decisions on whether purse string closure is superior to that of second intention healing and thus worth considering or inferior and not worth performing.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Over 18 years of age
• Able to give informed consent themselves
• Willing to return for follow-up visits
• Post-operative defects greater than 8 mm (in greatest diameter or length of circular or oval geometric shape) on the trunk and extremities (including the shin, hands, and feet)

Exclusion Criteria

• Mentally handicapped
• Unable to understand written and oral English
• Incarceration
• Under 18 years of age
• Unwilling to return for follow-up
• Pregnant women
• Wounds less than 8 mm in length
• Wounds on the head, neck or digits
• Patients in which primary linear closure is recommended

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second Intent	Purse-String	Surgical wounds are allowed to heal without sutures.
Second Intent	Second Intent	Surgical wounds are allowed to heal without sutures.
Purse-String	Purse-String	Surgical wounds are healed via suturing.
Purse-String	Second Intent	Surgical wounds are healed via suturing.

Primary Outcome Measures

Name	Time	Method
Assessment of Scar on the Patient and Observer Scar Assessment Scale	3 months	After surgical procedure, subjects will be randomized into one of two wound healing groups: by second intention (no sutures) or by purse-string closure (with sutures). After 3 months, subjects will return to clinic for evaluation of the pain scale and cosmesis of both types of healing techniques.

Trial Locations

Locations (1)

University of California-Davis, Dept. of Dermatology; 🇺🇸 Sacramento, California, United States