Evaluation of Purse-String Closure Vs Second Intention

University of California (UC) Davis

Status: Completed

Conditions: Wound Closure Techniques

Treatments: Procedure: Purse-String; Procedure: Second Intent

Study type: Interventional

Funder types: Other

Identifiers

NCT02062866

407301

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Purse-String

Active Comparator group

Description:

Surgical wounds are healed via suturing.

Treatment:

Procedure: Purse-String

Procedure: Second Intent

Second Intent

Active Comparator group

Description:

Surgical wounds are allowed to heal without sutures.

Treatment:

Procedure: Purse-String

Procedure: Second Intent