Cesarean Section, Wound Complications, Patient Satisfaction, Pain Measurement
Conditions
Keywords
Staples, Sutures, Wound infections, Cosmesis, Aesthetic appearance of skin incision
Brief summary
To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
Detailed description
Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.
Interventions
OTHERStaples
Interrupted Ethicon Staples
OTHERSuture
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Sponsors
Main Line Health
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.
Exclusion criteria
* Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels \> 95 and 120 respectively within the week prior to delivery), * Vertical skin incisions * Chronic steroid use * Active lupus flare * HIV/AIDS * Current treatment for cancer or a history of radiation to the abdomen/pelvis * Current treatment with immunosuppressant medications secondary to history of transplantation * Emergency cesarean(precluding informed consent prior to surgery) * Lack of access to a phone * Allergy to suture or staple material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Complications | Within 6 weeks of postpartum | The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Closure Method and Scar Appearance | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied. |
| Pain Perception | Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean | Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions. |
| Additional Provider Visits | Within 6 weeks postpartum | Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication). |
| Number of Participants With Primary Versus Repeat Cesarean | At randomization. | Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat) |
| Intraoperative Trial Details - Duration of Operation and Skin Closure | Time of Cesarean | Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure |
| Patient Scar Assessment Scale Scores for Evaluation of Cosmesis | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior. |
| Length of Hospital Stay | Immediate postpartum. | Length of hospital stay (days) |
| Number of Participants That Received Anticoagulation Within 24 Hours | Within 24 hours postpartum. | Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively) |
| Number of Participants Diagnosed With Endomyometritis | Immediate postpartum. | Number of participants diagnosed with endomyometritis requiring antibiotics |
| Change in Hemoglobin Pre-operatively to Post-operatively | Up to 72 hours before and 24 hours after cesarean. | Median change in hemoglobin from preoperative value (g/dL) to post-operatively. |
| Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. | Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior. |
| Intraoperative Trial Details - Closure of Subcutaneous Tissue | Time of Cesarean | Number of participants requiring subcutaneous tissue closure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suture Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) | 370 |
| Staples Interrupted Ethicon Staples | 376 |
| Total | 746 |
Baseline characteristics
| Characteristic | Staples | Total | Suture |
|---|---|---|---|
| Age, Continuous | 31.0 years | 31.0 years | 31.0 years |
| Number of Previous Cesareans 0 Previous Cesareans | 177 Participants | 357 Participants | 180 Participants |
| Number of Previous Cesareans 1 Previous Cesarean | 132 Participants | 252 Participants | 120 Participants |
| Number of Previous Cesareans More than 1 Previous Cesarean | 67 Participants | 137 Participants | 70 Participants |
| Pregnancy History - Singleton Gestation | 351 Participants | 704 Participants | 353 Participants |
| Race/Ethnicity, Customized African American | 167 Participants | 325 Participants | 158 Participants |
| Race/Ethnicity, Customized Asian | 22 Participants | 38 Participants | 16 Participants |
| Race/Ethnicity, Customized Caucasian | 154 Participants | 316 Participants | 162 Participants |
| Race/Ethnicity, Customized Hispanic | 24 Participants | 43 Participants | 19 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 23 Participants | 15 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 376 Participants | 746 Participants | 370 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Term Gestation | 329 Participants | 646 Participants | 317 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 370 | 0 / 376 |
| other Total, other adverse events | 18 / 370 | 40 / 376 |
| serious Total, serious adverse events | 0 / 370 | 0 / 376 |
Outcome results
Primary
Number of Participants With Wound Complications
The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.
Time frame: Within 6 weeks of postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suture | Number of Participants With Wound Complications | Total patients with at least 1 wound complicatin | 18 Participants |
| Suture | Number of Participants With Wound Complications | Infection | 9 Participants |
| Suture | Number of Participants With Wound Complications | Hematoma | 2 Participants |
| Suture | Number of Participants With Wound Complications | Seroma | 5 Participants |
| Suture | Number of Participants With Wound Complications | Separation | 6 Participants |
| Suture | Number of Participants With Wound Complications | Readmission for wound complication | 2 Participants |
| Staples | Number of Participants With Wound Complications | Separation | 28 Participants |
| Staples | Number of Participants With Wound Complications | Total patients with at least 1 wound complicatin | 40 Participants |
| Staples | Number of Participants With Wound Complications | Seroma | 6 Participants |
| Staples | Number of Participants With Wound Complications | Infection | 14 Participants |
| Staples | Number of Participants With Wound Complications | Readmission for wound complication | 3 Participants |
| Staples | Number of Participants With Wound Complications | Hematoma | 4 Participants |
Secondary
Additional Provider Visits
Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).
Time frame: Within 6 weeks postpartum
Population: The number analyzed in the Number of visits - diagnosed wound complication and Number of visits - no diagnosed wound complication rows indicates the breakdown of subjects within each arm that did and did not have a diagnosed wound complication.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Suture | Additional Provider Visits | All wound visits | .9 Number of Visits per participant |
| Suture | Additional Provider Visits | Number of visits - diagnosed wound complication | 2.7 Number of Visits per participant |
| Suture | Additional Provider Visits | Number of visits - no diagnosed wound complication | .8 Number of Visits per participant |
| Staples | Additional Provider Visits | All wound visits | 1.5 Number of Visits per participant |
| Staples | Additional Provider Visits | Number of visits - diagnosed wound complication | 2.9 Number of Visits per participant |
| Staples | Additional Provider Visits | Number of visits - no diagnosed wound complication | 1.4 Number of Visits per participant |
Secondary
Change in Hemoglobin Pre-operatively to Post-operatively
Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
Time frame: Up to 72 hours before and 24 hours after cesarean.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Suture | Change in Hemoglobin Pre-operatively to Post-operatively | -1.8 g/dL |
| Staples | Change in Hemoglobin Pre-operatively to Post-operatively | -1.8 g/dL |
Secondary
Intraoperative Trial Details - Closure of Subcutaneous Tissue
Number of participants requiring subcutaneous tissue closure
Time frame: Time of Cesarean
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture | Intraoperative Trial Details - Closure of Subcutaneous Tissue | 201 Participants |
| Staples | Intraoperative Trial Details - Closure of Subcutaneous Tissue | 202 Participants |
Secondary
Intraoperative Trial Details - Duration of Operation and Skin Closure
Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
Time frame: Time of Cesarean
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Suture | Intraoperative Trial Details - Duration of Operation and Skin Closure | Duration of Operation | 58.5 Minutes |
| Suture | Intraoperative Trial Details - Duration of Operation and Skin Closure | Duration of Skin Closure | 15 Minutes |
| Staples | Intraoperative Trial Details - Duration of Operation and Skin Closure | Duration of Operation | 51 Minutes |
| Staples | Intraoperative Trial Details - Duration of Operation and Skin Closure | Duration of Skin Closure | 6 Minutes |
Secondary
Length of Hospital Stay
Length of hospital stay (days)
Time frame: Immediate postpartum.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Suture | Length of Hospital Stay | 4.4 Days |
| Staples | Length of Hospital Stay | 4.5 Days |
Secondary
Number of Participants Diagnosed With Endomyometritis
Number of participants diagnosed with endomyometritis requiring antibiotics
Time frame: Immediate postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture | Number of Participants Diagnosed With Endomyometritis | 11 Participants |
| Staples | Number of Participants Diagnosed With Endomyometritis | 7 Participants |
Secondary
Number of Participants That Received Anticoagulation Within 24 Hours
Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
Time frame: Within 24 hours postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Suture | Number of Participants That Received Anticoagulation Within 24 Hours | 14 Participants |
| Staples | Number of Participants That Received Anticoagulation Within 24 Hours | 17 Participants |
Secondary
Number of Participants With Primary Versus Repeat Cesarean
Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
Time frame: At randomization.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Suture | Number of Participants With Primary Versus Repeat Cesarean | BMI 30 or greater - primary cesarean delivery | 109 Participants |
| Suture | Number of Participants With Primary Versus Repeat Cesarean | BMI 30 or greater - repeat cesarean delivery | 126 Participants |
| Suture | Number of Participants With Primary Versus Repeat Cesarean | BMI less than 30 - primary cesarean delivery | 71 Participants |
| Suture | Number of Participants With Primary Versus Repeat Cesarean | BMI less than 30 - repeat cesarean delivery | 64 Participants |
| Staples | Number of Participants With Primary Versus Repeat Cesarean | BMI less than 30 - repeat cesarean delivery | 67 Participants |
| Staples | Number of Participants With Primary Versus Repeat Cesarean | BMI 30 or greater - primary cesarean delivery | 106 Participants |
| Staples | Number of Participants With Primary Versus Repeat Cesarean | BMI less than 30 - primary cesarean delivery | 71 Participants |
| Staples | Number of Participants With Primary Versus Repeat Cesarean | BMI 30 or greater - repeat cesarean delivery | 132 Participants |
Secondary
Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.
Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Suture | Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. | 12 score on a scale |
| Staples | Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. | 13 score on a scale |
Secondary
Pain Perception
Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.
Time frame: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Suture | Pain Perception | 48 - 72 hours | 4.3 score on a scale |
| Suture | Pain Perception | 24 - 47 hours | 4.3 score on a scale |
| Suture | Pain Perception | Pain at time of Discharge | 3.5 score on a scale |
| Suture | Pain Perception | Less than 24 hours | 3.5 score on a scale |
| Staples | Pain Perception | Pain at time of Discharge | 3.6 score on a scale |
| Staples | Pain Perception | 48 - 72 hours | 4.2 score on a scale |
| Staples | Pain Perception | Less than 24 hours | 3.6 score on a scale |
| Staples | Pain Perception | 24 - 47 hours | 4.3 score on a scale |
Secondary
Patient Satisfaction With Closure Method and Scar Appearance
Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Population: Patient satisfaction data were available for 606 participants. Two participants in the Staples arm did not provide scores for scar appearance satisfaction. This is why we are representing 305 of the 307 subjects' responses to satisfaction of scar appearance.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Suture | Patient Satisfaction With Closure Method and Scar Appearance | Satisfaction with Closure Method | 9 score on a scale |
| Suture | Patient Satisfaction With Closure Method and Scar Appearance | Satisfaction with Scar Appearance | 9 score on a scale |
| Staples | Patient Satisfaction With Closure Method and Scar Appearance | Satisfaction with Closure Method | 10 score on a scale |
| Staples | Patient Satisfaction With Closure Method and Scar Appearance | Satisfaction with Scar Appearance | 9 score on a scale |
Secondary
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.
Time frame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Suture | Patient Scar Assessment Scale Scores for Evaluation of Cosmesis | 15 score on a scale |
| Staples | Patient Scar Assessment Scale Scores for Evaluation of Cosmesis | 20 score on a scale |