Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Purpose: The aims of this randomized clinical trial are:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wound closure device (Steri-Strip™) | Device | wound closure with steri-strip S |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Postoperative Incisional Comfort | Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable | 10 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carolyn L Kerrigan, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20048611 | Derived | 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. |
Not provided
Not provided
Patients declined
all woman undergoing bilateral breast reduction using the Wise pattern approach. Pts were recruited between Feb 2006 and Sept 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wounds Closed With Device | segment of wounds closed with steri-strip device |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Kerrigan | Dartmouth-Hitchcock | 603 650-5148 | carolyn.l.kerrigan@hitchcock.org |
Not provided
| ID | Term |
|---|---|
| C536821 | Gigantomastia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Patient Postoperative Incisional Comfort | Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable | Posted | Mean | Standard Deviation | units on a scale | 10 days |
|
|
|
| Primary | 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 | those who completed application of devices intraoperatively | Posted | Mean | Standard Deviation | minutes | intraoperatively |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | Wounds Closed With Suture | wound segments closed with traditional suture | 0 | 74 | 0 | 74 |
Not provided
Not provided