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CompletedNCT02062866Updated Apr 16, 2015

Evaluation of Purse-String Closure Vs Second Intention

An interventional study of Purse-String and Second Intent in Wound Closure Techniques, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Wound Closure Techniques
03

In context

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Purse-String

    Surgical wounds are healed via suturing.

    Procedure: Purse-String · Procedure: Second Intent

  • Active comparator
    Second Intent

    Surgical wounds are allowed to heal without sutures.

    Procedure: Purse-String · Procedure: Second Intent

Interventions

  • ProcedurePurse-String

    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.

  • ProcedureSecond Intent

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

06

What researchers measure

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.

    Time frame: 3 months

07

Study locations

1 site
  • University of California-Davis, Dept. of Dermatology
    Sacramento, California 95816, United States
08

References and documents

Publications

  • 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. PubMed 25372450 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02062866
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Feb 14, 2014
Start date
Apr 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Apr 16, 2015

Study contacts

Daniel Eisen, M.D.
principal investigator · University of California, Davis

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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