Evaluation of Purse-String Closure Vs Second Intention

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.

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Key information

Conditions

Wound Closure Techniques

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California-Davis, Dept. of Dermatology

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Second Intent

Procedure

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

Primary outcomes

Assessment of Scar on the Patient and Observer Scar Assessment Scale

Time frame: 3 months

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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Intradermal Purse-String Closure Vs Second Intention Healing

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Feb 14, 2014
Registry last updated: Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed