Evaluation of Purse-String Closure Vs Second Intention

Study Overview
=================
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.

Official Title
-----------------
Intradermal Purse-String Closure Vs Second Intention Healing

Conditions
-----------------
Wound Closure Techniques

Intervention / Treatment
-----------------
* Procedure: Purse-String
* Procedure: Second Intent


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Purse-String<br>Surgical wounds are healed via suturing. | Procedure: Purse-String<br>* 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.<br>Procedure: Second Intent<br>* The wound will not be sutured, and allowed to heal on its own.<br>|
| Active Comparator: Second Intent<br>Surgical wounds are allowed to heal without sutures. | Procedure: Purse-String<br>* 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.<br>Procedure: Second Intent<br>* The wound will not be sutured, and allowed to heal on its own.<br>|

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 |