Evaluation of Purse-String Closure Vs Second Intention

NCT ID: NCT02062866

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Closure Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Purse-String

Surgical wounds are healed via suturing.

Group Type ACTIVE_COMPARATOR

Purse-String

Intervention Type 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

Intervention Type PROCEDURE

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

Second Intent

Surgical wounds are allowed to heal without sutures.

Group Type ACTIVE_COMPARATOR

Purse-String

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

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Purse-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.

Intervention Type PROCEDURE

Second Intent

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Eisen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California-Davis, Dept. of Dermatology

Sacramento, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25372450 (View on PubMed)

Related Links

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http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

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407301

Identifier Type: -

Identifier Source: org_study_id

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