Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-03-31

Brief Summary

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Purpose: The aims of this randomized clinical trial are:

1. to assess scar quality from the patient and surgeon perspectives
2. to assess patient comfort in the days immediately following surgery
3. to assess the time taken to complete closure in the operating room.
4. the financial benefit or cost for the institution of using Steri Strip S will also be estimated.

Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.

Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.

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Detailed Description

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Conditions

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Breast Hypertrophy Abdominal Elastosis Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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wound closure device (Steri-Strip™)

wound closure with steri-strip S

Intervention Type DEVICE

Other Intervention Names

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3M™ Steri-Strip™ S Surgical Skin Closure

Eligibility Criteria

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Inclusion Criteria

* Patients are eligible for enrollment if they agree to provide informed consent, are at least 18 years of age, in generally good health, and available for follow-up in the 5-7 month time frame.

Exclusion Criteria

* Women known to be pregnant, minors, patients potentially incompetent to provide informed consent or complete the surveys described in our protocol will be excluded from this trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No