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OpenTrials
Completed

NCT Number: NCT00727025

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

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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Key information

Conditions

Breast Hypertrophy Abdominal Elastosis Breast Reconstruction Gigantomastia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

wound closure device (Steri-Strip™)

Device

wound closure with steri-strip S

Other names: 3M™ Steri-Strip™ S Surgical Skin Closure

Primary outcomes

  1. Scar Quality at 6 Months Postoperative

    Time frame: 6 months

    Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.

  2. Time to Perform Wound Closure

    Time frame: intraoperatively

    Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture

Secondary outcomes

  1. Patient Postoperative Incisional Comfort

    Time frame: 10 days

    Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Closing Linear Incisions in Plastic Surgery: A Randomized Clinical Trial Comparing a New Coaptive Film Device Versus Standard Subcuticular Sutures for Scar Quality, Patient Comfort, and Closure Time

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2008
Registry last updated
Oct 31, 2023

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.

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