Evaluation of Purse-String Closure Vs Second Intention

N/ACompletedNCT02062866

University of California, Davis50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Wound Closure Techniques

Interventions

Purse-StringPROCEDURE

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 IntentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California-Davis, Dept. of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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