Evaluation of Purse-String Closure Vs Second Intention

Intradermal Purse-String Closure Vs Second Intention Healing

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.

Study Overview

• Status: Completed
• Conditions: Wound Closure Techniques
• Intervention / Treatment: Procedure: Purse-String; Procedure: Second Intent

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California-Davis, Dept. of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Purse-String; Surgical wounds are healed via suturing.	Procedure: Purse-String; The wound will be closed using one, long, continuous suture which will enter and exit run through the skin along the inner edge of the wound. The start and stopping point will be adjacent to one another. The suture will then be pulled" on either side to essentially cinch down the wound, decreasing the size of the wound.; Procedure: Second Intent; The wound will not be sutured, and allowed to heal on its own.
Active Comparator: Second Intent; Surgical wounds are allowed to heal without sutures.	Procedure: Purse-String; The wound will be closed using one, long, continuous suture which will enter and exit run through the skin along the inner edge of the wound. The start and stopping point will be adjacent to one another. The suture will then be pulled" on either side to essentially cinch down the wound, decreasing the size of the wound.; Procedure: Second Intent; The wound will not be sutured, and allowed to heal on its own.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Scar on the Patient and Observer Scar Assessment Scale	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.	3 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General Publications

• Joo J, Custis T, Armstrong AW, King TH, Omlin K, Kappel ST, Eisen DB. Purse-string suture vs second intention healing: results of a randomized, blind clinical trial. JAMA Dermatol. 2015 Mar;151(3):265-70. doi: 10.1001/jamadermatol.2014.2313.

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): April 16, 2015
• Last Update Submitted That Met QC Criteria: April 15, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 407301