Cesarean Delivery, Glove Perforation
Conditions
Keywords
Cesarean delivery, Surgical Needles, blunt-tip needles, surgical glove perforation
Brief summary
This study is assessing whether there is a decrease in surgical glove punctures using blunt tipped needles compared with sharp needles for suturing during Cesarean Delivery.
Interventions
OTHERBlunt tipped needle
The Cesarean delivery is performed using blunt tipped needles.
OTHERSharp needles
The cesarean is performed using standard sharp surgical suture needles.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age undergoing Cesarean Delivery
Exclusion criteria
* Patient less than 18 years of age. * Patient not undergoing Cesarean Delivery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Glove Perforation. | 1 week | Direct measurement of the number of glove perforations listed by surgical case. |
Secondary
| Measure | Time frame |
|---|---|
| Surgeon Satisfaction by Likert Scale. | 1 week |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blunt Needles Cesarean Delivery Performed with Blunt-tipped surgical Needles | 117 |
| Sharp Needles Cesarean delivery performed with sharp surgical needles. | 123 |
| Total | 240 |
Baseline characteristics
| Characteristic | Blunt Needles | Sharp Needles | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 123 Participants | 240 Participants |
| Region of Enrollment United States | 117 participants | 123 participants | 240 participants |
| Sex: Female, Male Female | 117 Participants | 123 Participants | 240 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 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 / 117 | 0 / 123 |
| serious Total, serious adverse events | 0 / 117 | 0 / 123 |
Outcome results
Primary
Surgical Glove Perforation.
Direct measurement of the number of glove perforations listed by surgical case.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blunt Needles | Surgical Glove Perforation. | 30 Cases with a glove puncture |
| Sharp Needles | Surgical Glove Perforation. | 30 Cases with a glove puncture |
Secondary
Surgeon Satisfaction by Likert Scale.
Time frame: 1 week