Abdominal Elastosis, Breast Hypertrophy, Breast Reconstruction
Conditions
Keywords
skin closure devices, linear scars
Brief summary
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.
Interventions
DEVICEwound closure device (Steri-Strip™)
wound closure with steri-strip S
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Quality at 6 Months Postoperative | 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. |
| Time to Perform Wound Closure | intraoperatively | Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Postoperative Incisional Comfort | 10 days | Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable |
Countries
United States
Participant flow
Recruitment details
all woman undergoing bilateral breast reduction using the Wise pattern approach. Pts were recruited between Feb 2006 and Sept 2007
Pre-assignment details
Patients declined
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 23 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wounds Closed With Device | Scar Quality at 6 Months Postoperative | 3.8 units on a scale | Standard Deviation 2.9 |
| Wounds Closed With Suture | Scar Quality at 6 Months Postoperative | 2.6 units on a scale | Standard Deviation 2.1 |
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
Time frame: intraoperatively
Population: those who completed application of devices intraoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wounds Closed With Device | Time to Perform Wound Closure | 2.0 minutes | Standard Deviation 1.1 |
| Wounds Closed With Suture | Time to Perform Wound Closure | 4.6 minutes | Standard Deviation 1.6 |
Secondary
Patient Postoperative Incisional Comfort
Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable
Time frame: 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wounds Closed With Device | Patient Postoperative Incisional Comfort | 5.8 units on a scale | Standard Deviation 2.7 |
| Wounds Closed With Suture | Patient Postoperative Incisional Comfort | 6.9 units on a scale | Standard Deviation 2 |