Evaluation of Purse-String Closure Vs Second Intention

Wound Closure Techniques Clinical Trial

Official title:

Intradermal Purse-String Closure Vs Second Intention Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062866
• Other study ID #: 407301
• Status: Completed
• Phase: N/A
• First received: November 1, 2013
• Last updated: April 15, 2015
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Wound Closure Techniques

Intervention

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.
• Second Intent
The wound will not be sutured, and allowed to heal on its own.

Locations

Country	Name	City	State
United States	University of California-Davis, Dept. of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   University of California-Davis Department of Dermatology Clinical Research