Cesarean Section, Obesity, Severe
Conditions
Brief summary
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of \>/= 40kg/m2.
Detailed description
A. To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD). B. No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD). C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.
Interventions
DEVICEAbsorbable subcuticular suture
Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
DEVICEStainless steel staples
Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Sponsors
University of California, Irvine
MemorialCare Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Women \> 18 years old undergoing cesarean delivery (CD) 2. BMI of \>/= 40 kg/m2 as determined by height and weight reported during their admission 3. Live gestation 23 weeks or greater 4. Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
Exclusion criteria
1. Active lupus flare 2. HIV/AIDS 3. Current treatment for cancer or h/o radiation to the abdomen/pelvis 4. Hypersensitivity to steri-strips
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum | Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to Skin Incision | At time of surgery and hospitalization | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Operating Surgeon Level | At time of surgery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Surgical Assistant Level | At time of surgery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Total Operative Time | At time of surgery and hospitalization | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Total Blood Loss | At time of surgery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Number of Participants With Blood Transfusion | At time of surgery and hospitalization | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Change in Hemoglobin (Pre-delivery and Post-delivery) | At time of surgery (pre-delivery) and post-delivery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Number of Participants With 5 Minute Apgar Score <7 | At time of delivery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome). |
| Number of Participants Receiving Postpartum Prophylactic Anticoagulation | During hospitalization | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Total Length of Hospital Stay | At time of surgery and hospitalization | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
| Patient Pain Score (From 1 to 10) | Within 2 weeks postpartum | Patients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain). |
| Patient Satisfaction With Wound Healing and Appearance | At time of hospital discharge and at 2 weeks postpartum | Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned). |
| Neonatal Birthweight | At time of delivery | Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Absorbable Subcuticular Suture Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).
Absorbable subcuticular suture: Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD). | 119 |
| Stainless Steel Staples Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).
Stainless steel staples: Patients will receive stainless steel staples for skin closure at time of cesarean delivery (CD). | 119 |
| Total | 238 |
Baseline characteristics
| Characteristic | Total | Stainless Steel Staples | Absorbable Subcuticular Suture |
|---|---|---|---|
| Age, Continuous | 31.25 years STANDARD_DEVIATION 0.21 | 31.4 years STANDARD_DEVIATION 5.3 | 31.1 years STANDARD_DEVIATION 5.6 |
| Chorioamnionitis | 7 Participants | 3 Participants | 4 Participants |
| College Graduate | 44 Participants | 21 Participants | 23 Participants |
| Diabetes Gestational | 41 Participants | 23 Participants | 18 Participants |
| Diabetes None | 159 Participants | 77 Participants | 82 Participants |
| Diabetes Pre-gestational | 38 Participants | 19 Participants | 19 Participants |
| Gestational age at delivery | 38.5 Weeks STANDARD_DEVIATION 0 | 38.2 Weeks STANDARD_DEVIATION 2.5 | 38.8 Weeks STANDARD_DEVIATION 1.9 |
| Hypertensive Disease Gestational | 22 Participants | 10 Participants | 12 Participants |
| Hypertensive Disease None | 158 Participants | 73 Participants | 85 Participants |
| Hypertensive Disease Preeclampsia | 33 Participants | 20 Participants | 13 Participants |
| Hypertensive Disease Pre-gestational | 25 Participants | 16 Participants | 9 Participants |
| Married/partner | 135 Participants | 66 Participants | 69 Participants |
| Number of previous cesarean delivery (CD) 1 | 78 Participants | 42 Participants | 36 Participants |
| Number of previous cesarean delivery (CD) 2 or more | 73 Participants | 35 Participants | 38 Participants |
| Number of previous cesarean delivery (CD) o | 87 Participants | 42 Participants | 45 Participants |
| Private Insurance | 59 Participants | 28 Participants | 31 Participants |
| Race/Ethnicity, Customized African American | 41 participants | 19 participants | 22 participants |
| Race/Ethnicity, Customized Asian | 15 participants | 10 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 46 participants | 24 participants | 22 participants |
| Race/Ethnicity, Customized Hispanic | 127 participants | 59 participants | 68 participants |
| Race/Ethnicity, Customized Other | 9 participants | 7 participants | 2 participants |
| Region of Enrollment United States | 238 participants | 119 participants | 119 participants |
| Sex: Female, Male Female | 238 Participants | 119 Participants | 119 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Singleton Gestation | 225 Participants | 114 Participants | 111 Participants |
| Time since last cesarean delivery (CD) More than 5 years | 66 Participants | 33 Participants | 33 Participants |
| Time since last cesarean delivery (CD) No history of prior cesarean delivery (CD) | 87 Participants | 42 Participants | 45 Participants |
| Time since last cesarean delivery (CD) Within 5 years | 85 Participants | 44 Participants | 41 Participants |
| Tobacco use Current | 10 Participants | 3 Participants | 7 Participants |
| Tobacco use None | 186 Participants | 90 Participants | 96 Participants |
| Tobacco use Past | 42 Participants | 26 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 119 |
| other Total, other adverse events | 0 / 119 | 0 / 119 |
| serious Total, serious adverse events | 0 / 119 | 0 / 119 |
Outcome results
Primary
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
Time frame: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Population: The last 2 rows show the rate of healed versus non-healed wound complications out of the total number of wound complications diagnosed in the staples group (n=8) and suture group (n=5).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Not healed at 6 weeks | 2 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 1 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 7 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Healed at 6 weeks | 6 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 0 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 8 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 0 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 2 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 5 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 0 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 3 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 0 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Healed at 6 weeks | 4 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Not healed at 6 weeks | 1 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 15 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 3 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 3 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 1 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Not healed at 6 weeks | 3 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Healed at 6 weeks | 12 Participants |
| Stainless Steel Staples at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 11 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 0 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Not healed at 6 weeks | 1 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 3 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 16 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 11 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 2 Participants |
| Absorbable Subcuticular Suture at 2 WEEKS POSTPARTUM | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Healed at 6 weeks | 11 Participants |
| Stainless Steel Staples TOTAL WOUND COMPLICATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 1 Participants |
| Stainless Steel Staples TOTAL WOUND COMPLICATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 4 Participants |
| Stainless Steel Staples TOTAL WOUND COMPLICATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 23 Participants |
| Stainless Steel Staples TOTAL WOUND COMPLICATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 3 Participants |
| Stainless Steel Staples TOTAL WOUND COMPLICATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 15 Participants |
| Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Deep separation | 2 Participants |
| Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection and separation | 3 Participants |
| Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Superficial separation | 14 Participants |
| Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Infection | 2 Participants |
| Absorbable Subcuticular Suture TOTAL WOUND COMPLCATIONS | Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum | Composite wound complication | 21 Participants |
Secondary
Change in Hemoglobin (Pre-delivery and Post-delivery)
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery (pre-delivery) and post-delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Change in Hemoglobin (Pre-delivery and Post-delivery) | 1.68 Change in grams of hemoglobin | Standard Deviation 1.5 |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Change in Hemoglobin (Pre-delivery and Post-delivery) | 1.93 Change in grams of hemoglobin | Standard Deviation 1.4 |
Secondary
Neonatal Birthweight
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Neonatal Birthweight | 3406 grams | Standard Deviation 878 |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Neonatal Birthweight | 3426 grams | Standard Deviation 711 |
Secondary
Number of Participants According to Skin Incision
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Number of Participants According to Skin Incision | Skin incision: Midline vertical | 5 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Number of Participants According to Skin Incision | Skin incision: Pfannenstiel | 114 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Number of Participants According to Skin Incision | Skin incision: Pfannenstiel | 118 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Number of Participants According to Skin Incision | Skin incision: Midline vertical | 1 Participants |
Secondary
Number of Participants Receiving Postpartum Prophylactic Anticoagulation
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: During hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Number of Participants Receiving Postpartum Prophylactic Anticoagulation | 66 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Number of Participants Receiving Postpartum Prophylactic Anticoagulation | 74 Participants |
Secondary
Number of Participants With 5 Minute Apgar Score <7
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable The Apgar score, developed by Virginia Apgar describes the condition of the newborn infant immediately after birth and, when properly applied, is a tool for standardized assessment 18. It also provides a mechanism to record fetal-to-neonatal transition. This scoring system provided a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. The Apgar score ranges from 0 (lowest, poor outcome) to 10 (highest, good outcome).
Time frame: At time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Number of Participants With 5 Minute Apgar Score <7 | 2 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Number of Participants With 5 Minute Apgar Score <7 | 1 Participants |
Secondary
Number of Participants With Blood Transfusion
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Number of Participants With Blood Transfusion | 4 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Number of Participants With Blood Transfusion | 8 Participants |
Secondary
Operating Surgeon Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Operating Surgeon Level | Surgeon level: Attending/Fellow | 67 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Operating Surgeon Level | Surgeon level: Resident | 52 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Operating Surgeon Level | Surgeon level: Attending/Fellow | 66 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Operating Surgeon Level | Surgeon level: Resident | 53 Participants |
Secondary
Patient Pain Score (From 1 to 10)
Patients' pain associated with their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their pain on a scale of 0 (no pain) to 10 (worst pain).
Time frame: Within 2 weeks postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Patient Pain Score (From 1 to 10) | 2 Score on a scale |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Patient Pain Score (From 1 to 10) | 2 Score on a scale |
Secondary
Patient Satisfaction With Wound Healing and Appearance
Patients' satisfaction with the healing of their wound within 7-14 days after hospital discharge using a self-administered questionnaire that asked patients to rate their overall satisfaction with their wound healing and appearance (1=least satisfied, 10=most satisfied). Patients were also asked to rate their concern regarding their wound healing (1= least concerned and 10 = most concerned).
Time frame: At time of hospital discharge and at 2 weeks postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Patient Satisfaction With Wound Healing and Appearance | Concern about wound healing (1=least, 10=most) | 1 Score on a scale |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Patient Satisfaction With Wound Healing and Appearance | Wound appearance satisfaction (1=least, 10=most) | 10 Score on a scale |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Patient Satisfaction With Wound Healing and Appearance | Wound appearance satisfaction (1=least, 10=most) | 10 Score on a scale |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Patient Satisfaction With Wound Healing and Appearance | Concern about wound healing (1=least, 10=most) | 1 Score on a scale |
Secondary
Surgical Assistant Level
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Surgical Assistant Level | Assistant Level: Attending/Fellow | 101 Participants |
| Stainless Steel Staples at HOSPITAL DISCHARGE | Surgical Assistant Level | Assistant Level: Resident | 18 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Surgical Assistant Level | Assistant Level: Attending/Fellow | 97 Participants |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Surgical Assistant Level | Assistant Level: Resident | 22 Participants |
Secondary
Total Blood Loss
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Total Blood Loss | 773 mL | Standard Deviation 432 |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Total Blood Loss | 837 mL | Standard Deviation 447 |
Secondary
Total Length of Hospital Stay
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Total Length of Hospital Stay | 4.9 days | Standard Deviation 0.9 |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Total Length of Hospital Stay | 4.9 days | Standard Deviation 2.1 |
Secondary
Total Operative Time
Date were analyzed with independent t, X2 and Fisher's exact tests, where applicable
Time frame: At time of surgery and hospitalization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stainless Steel Staples at HOSPITAL DISCHARGE | Total Operative Time | 43.4 minutes | Standard Deviation 21.9 |
| Absorbable Subcuticular Suture at HOSPITAL DISCHARGE | Total Operative Time | 55.8 minutes | Standard Deviation 26 |