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

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Dartmouth Health

Status

Completed

Conditions

Breast Reconstruction
Breast Hypertrophy
Abdominal Elastosis

Treatments

Device: wound closure device (Steri-Strip™)

Study type

Interventional

Funder types

Other

Identifiers

NCT00727025
CPHS 20069

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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