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| Name | Class |
|---|---|
| Main Line Health | OTHER |
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To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Staples | Active Comparator | Interrupted Ethicon Staples |
|
| Suture | Active Comparator | Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staples | Other | Interrupted Ethicon Staples |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 6 weeks of postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A. Dhanya Mackeen, MD, MPH | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | United States | |||
| Thomas Jefferson University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19254586 | Background | Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019. | |
| 9350017 | Background | Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Suture | Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) |
| FG001 | Staples | Interrupted Ethicon Staples |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Suture | Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) |
| BG001 | Staples | Interrupted Ethicon Staples |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Within 6 weeks of postpartum |
|
Adverse events were monitored from the time of randomization to 30 days postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Suture | Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Complications | Skin and subcutaneous tissue disorders | Systematic Assessment | Wound complications are a known risk of both cesarean closure methods. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. A. Dhanya Mackeen | Geisinger | 570-714-1099 | admackeen@geisinger.edu |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Suture | Other | Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) |
|
|
| Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
| 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. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
| 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. | Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean |
| 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). | Within 6 weeks postpartum |
| Number of Participants With Primary Versus Repeat Cesarean | Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat) | At randomization. |
| 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 of Cesarean |
| Intraoperative Trial Details - Closure of Subcutaneous Tissue | Number of participants requiring subcutaneous tissue closure | Time of Cesarean |
| Length of Hospital Stay | Length of hospital stay (days) | Immediate postpartum. |
| Number of Participants That Received Anticoagulation Within 24 Hours | Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively) | Within 24 hours postpartum. |
| Number of Participants Diagnosed With Endomyometritis | Number of participants diagnosed with endomyometritis requiring antibiotics | Immediate postpartum. |
| Change in Hemoglobin Pre-operatively to Post-operatively | Median change in hemoglobin from preoperative value (g/dL) to post-operatively. | Up to 72 hours before and 24 hours after cesarean. |
| 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. | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| 12804476 | Background | Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577. |
| 20816153 | Background | Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011. |
| 26348166 | Derived | Mackeen AD, Khalifeh A, Fleisher J, Han C, Leiby B, Berghella V. Pain Associated With Cesarean Delivery Skin Closure: A Randomized Controlled Trial. Obstet Gynecol. 2015 Oct;126(4):702-707. doi: 10.1097/AOG.0000000000001043. |
| 24807325 | Derived | Mackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Pregnancy History - Singleton Gestation | Number of participants with singleton pregnancy | Count of Participants | Participants |
|
| Number of Previous Cesareans | Participants who had 0, 1, or more than one cesarean prior to study participation | Count of Participants | Participants |
|
| Term Gestation | Number of participants at 37 weeks or greater gestation at time of participation. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean |
|
|
|
| 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). | 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. | Posted | Mean | Full Range | Number of Visits per participant | Within 6 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Primary Versus Repeat Cesarean | Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat) | Posted | Count of Participants | Participants | At randomization. |
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | Minutes | Time of Cesarean |
|
|
|
| Secondary | Intraoperative Trial Details - Closure of Subcutaneous Tissue | Number of participants requiring subcutaneous tissue closure | Posted | Count of Participants | Participants | Time of Cesarean |
|
|
|
| Secondary | Length of Hospital Stay | Length of hospital stay (days) | Posted | Median | Inter-Quartile Range | Days | Immediate postpartum. |
|
|
|
| Secondary | Number of Participants That Received Anticoagulation Within 24 Hours | Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively) | Posted | Count of Participants | Participants | Within 24 hours postpartum. |
|
|
|
| Secondary | Number of Participants Diagnosed With Endomyometritis | Number of participants diagnosed with endomyometritis requiring antibiotics | Posted | Count of Participants | Participants | Immediate postpartum. |
|
|
|
| Secondary | Change in Hemoglobin Pre-operatively to Post-operatively | Median change in hemoglobin from preoperative value (g/dL) to post-operatively. | Posted | Median | Inter-Quartile Range | g/dL | Up to 72 hours before and 24 hours after cesarean. |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks. |
|
|
|
| 0 |
| 370 |
| 0 |
| 370 |
| 18 |
| 370 |
| EG001 | Staples | Interrupted Ethicon Staples | 0 | 376 | 0 | 376 | 40 | 376 |
|
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| Satisfaction with Scar Appearance |
|
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| 48 - 72 hours |
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| Pain at time of Discharge |
|
| Number of visits - diagnosed wound complication |
|
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| Number of visits - no diagnosed wound complication |
|
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| BMI less than 30 - primary cesarean delivery |
|
| BMI less than 30 - repeat cesarean delivery |
|