Trial Outcomes & Findings for Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure (NCT NCT00727025)
NCT ID: NCT00727025
Last Updated: 2023-10-31
Results Overview
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.
COMPLETED
NA
51 participants
6 months
2023-10-31
Participant Flow
all woman undergoing bilateral breast reduction using the Wise pattern approach. Pts were recruited between Feb 2006 and Sept 2007
Patients declined
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Physician Decision
|
23
|
Baseline Characteristics
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Baseline characteristics by cohort
| Measure |
All Participants
n=74 Participants
Participants randomized to have one segment of wounds closed with steri-strip device and the other wound segment closed with traditional suture closure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPatients 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.
Outcome measures
| Measure |
Wounds Closed With Device
n=51 Participants
segment of wounds closed with steri-strip device
|
Wounds Closed With Suture
n=51 Participants
wound segments closed with traditional suture
|
|---|---|---|
|
Scar Quality at 6 Months Postoperative
|
3.8 units on a scale
Standard Deviation 2.9
|
2.6 units on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: intraoperativelyPopulation: those who completed application of devices intraoperatively
Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture
Outcome measures
| Measure |
Wounds Closed With Device
n=51 Participants
segment of wounds closed with steri-strip device
|
Wounds Closed With Suture
n=51 Participants
wound segments closed with traditional suture
|
|---|---|---|
|
Time to Perform Wound Closure
|
2.0 minutes
Standard Deviation 1.1
|
4.6 minutes
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 10 daysUsing a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable
Outcome measures
| Measure |
Wounds Closed With Device
n=51 Participants
segment of wounds closed with steri-strip device
|
Wounds Closed With Suture
n=51 Participants
wound segments closed with traditional suture
|
|---|---|---|
|
Patient Postoperative Incisional Comfort
|
5.8 units on a scale
Standard Deviation 2.7
|
6.9 units on a scale
Standard Deviation 2.0
|
Adverse Events
Wounds Closed With Device
Wounds Closed With Suture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place