Evaluation of Purse-String Closure Vs Second Intention

NCT02062866 | Completed

• 1 other identifier: 407301
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Purse-String

ACTIVE COMPARATOR

Surgical wounds are healed via suturing.

Procedure: Purse-String; Procedure: Second Intent

Second Intent

ACTIVE COMPARATOR

Surgical wounds are allowed to heal without sutures.

Procedure: Purse-String; Procedure: Second Intent

Interventions

Purse-String PROCEDURE

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.

Purse-String; Second Intent

Second Intent PROCEDURE

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

Purse-String; Second Intent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Dept. of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

• 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.

  PMID: 25372450 DERIVED

Related Links

• University of California-Davis Department of Dermatology Clinical Research

Study Officials

• Daniel Eisen, M.D.

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: February 14, 2014
• Study Start: April 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (1)