NCT00727025

Brief Summary

Purpose: The aims of this randomized clinical trial are:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

May 20, 2013

Completed
Last Updated

October 31, 2023

Status Verified

May 1, 2013

Enrollment Period

2.5 years

First QC Date

July 30, 2008

Results QC Date

February 24, 2012

Last Update Submit

October 16, 2023

Conditions

Breast HypertrophyAbdominal ElastosisBreast Reconstruction

Keywords

skin closure deviceslinear scars

Outcome Measures

Primary Outcomes (2)

  • Scar Quality at 6 Months Postoperative

    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.

    6 months

  • Time to Perform Wound Closure

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

    intraoperatively

Secondary Outcomes (1)

  • Patient Postoperative Incisional Comfort

    10 days

Interventions

wound closure device (Steri-Strip™)DEVICE

wound closure with steri-strip S

Also known as: 3M™ Steri-Strip™ S Surgical Skin Closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (1)

  • Kerrigan CL, Homa K. Evaluation of a new wound closure device for linear surgical incisions: 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure. Plast Reconstr Surg. 2010 Jan;125(1):186-194. doi: 10.1097/PRS.0b013e3181c2a492.

    PMID: 20048611DERIVED

MeSH Terms

Conditions

Gigantomastia

Limitations and Caveats

1. patients not blinded 2. surgeons rated photographs of scars, while the patients were rating their actual scars. 3. All patients were caucasian

Results Point of Contact

Title
Dr. Carolyn Kerrigan
Organization
Dartmouth-Hitchcock
carolyn.l.kerrigan@hitchcock.org
603 650-5148

Study Officials

  • Carolyn L Kerrigan, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

July 1, 2005

Primary Completion

January 1, 2008

Study Completion

March 1, 2008

Last Updated

October 31, 2023

Results First Posted

May 20, 2013

Record last verified: 2013-05

Locations

US(1)