Wound
Conditions
Keywords
dermaclip, subcuticular, cesarean section, staples, adhesive latch, rousseau
Brief summary
The objective of this study was to compare the an adhesive latch device ( Dermaclip) to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.
Interventions
DEVICEDermaclip
Dermaclip is an adhesive latch device used for skin closure
DEVICESubcuticular suture
subcuticular suture will be used as the device to close the skin in this arm
Sponsors
Rubino Ob-Gyn Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
computer randomized list of closure type opened from a sealed envelope on the day of surgery
Intervention model description
A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device (dermaclip)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age greater than 18 2. Elective cesarean section 3. Term pregnancy
Exclusion criteria
1. Fever \>101F in the past 14 days 2. Antibiotics in the past 14 days 3. Suspected ongoing infection 4. Poorly controlled gestational diabetes 5. Allergic to adhesive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section | 18 months | The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Infections as measured in centimeters of erythema | 18 months | \- wound infections will measured in centimeters of redness/erythema around the infected area |
| Wound separation as measured in centimeters | 18 months | \- wound separation will be recorded centimeters |
| Patient Satisfaction scores | 18 months | \- patient satisfaction |
| Total surgery time | 18 months | \- total surgery time |
| Pain Scores | 18 months | \- pain scores using the visual analog pain scale (VAPS) system |
| BMI | 18 months | BMI of participants bmi (in kg/m2, weight in kg, height, in meters) |
| Ethnicity | 18 months | Ethnic origin |
| Race | 18 months | Race of participants |
| Age | 18 months | \- age (years) |
Countries
United States
Outcome results
None listed