Trial Outcomes & Findings for Randomized Clinical Trial of Skin Closure With Staples Versus Suture (NCT NCT01977612)
NCT ID: NCT01977612
Last Updated: 2017-07-31
Results Overview
COMPLETED
PHASE2
173 participants
4-8 weeks post-surgery
2017-07-31
Participant Flow
173 participants were enrolled to the study but 8 participants had a change in their surgical procedure which deemed them ineligible for study enrollment and were excluded from the study before randomization to the arms.
Participant milestones
| Measure |
Stainless Steel Staples
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
80
|
|
Overall Study
COMPLETED
|
84
|
79
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Stainless Steel Staples
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Baseline characteristics by cohort
| Measure |
Stainless Steel Staples
n=84 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=79 Participants
Skin closure using 4-0 monofilament sutures
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
57.1 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
57.4 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=99 Participants
|
79 participants
n=107 Participants
|
163 participants
n=206 Participants
|
|
Body mass index (BMI)
30-39.9
|
60 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Body mass index (BMI)
40-49.9
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Body mass index (BMI)
50 or greater
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Prior Abdominal Surgery
|
51 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Tobacco Use
Never
|
44 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Tobacco Use
Former
|
33 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Tobacco Use
Current
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Diabetes mellitus
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Cardiovascular disease
|
58 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Pulmonary disease
|
20 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Prior malignancy
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) class
1-2
|
39 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
American Society of Anesthesiologists (ASA) class
3-4
|
45 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Indications for surgery
Uterine cancer
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Indications for surgery
Ovarian/fallopian/peritoneal cancer
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Indications for surgery
Benign
|
22 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Indications for surgery
Other
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Indications for surgery
Synchronous primary
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4-8 weeks post-surgeryOutcome measures
| Measure |
Stainless Steel Staples
n=84 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=79 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
|
28 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 4-8 weeks post-surgeryPopulation: -Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.
Outcome measures
| Measure |
Stainless Steel Staples
n=75 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=70 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Incidence of Wound Disruption
|
21 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 4-8 weeks post-surgeryPurulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.
Outcome measures
| Measure |
Stainless Steel Staples
n=84 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=79 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Incidence of Wound Infection
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During surgeryPopulation: Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm
Time from skin incision to the end of skin closure
Outcome measures
| Measure |
Stainless Steel Staples
n=81 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=78 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Operative Time
|
3 minutes
Interval 2.0 to 4.0
|
11 minutes
Interval 9.0 to 15.0
|
SECONDARY outcome
Timeframe: 3-4 days post-surgeryPopulation: Data was not collected from any patients for this outcome measure
The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4-8 weeks post-operativePopulation: -Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm
* Ranges from 0 (worst) to 5 (best) * Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0
Outcome measures
| Measure |
Stainless Steel Staples
n=74 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=70 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
|
4 units on a scale
Interval 3.0 to 5.0
|
5 units on a scale
Interval 4.0 to 5.0
|
SECONDARY outcome
Timeframe: 4-8 weeks post-operativePopulation: -Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm
Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.
Outcome measures
| Measure |
Stainless Steel Staples
n=71 Participants
Skin closure using stainless steel staples.
|
4-0 Monofilament Sutures
n=67 Participants
Skin closure using 4-0 monofilament sutures
|
|---|---|---|
|
Median Patient Satisfaction Score of Scar Appearance
|
68 Patient Satisfaction Score
Interval 49.0 to 83.0
|
77 Patient Satisfaction Score
Interval 52.0 to 87.0
|
Adverse Events
Stainless Steel Staples
4-0 Monofilament Sutures
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lindsay Kuroki, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place