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low accrual
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| Name | Class |
|---|---|
| Cooper Companies | INDUSTRY |
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Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suture wound closure | Active Comparator | Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. |
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| Absorbable staple wound closure | Experimental | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSORB: subcuticular stapling device | Device | Under the skin stapling device that delivers absorbable staples |
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| Measure | Description | Time Frame |
|---|---|---|
| Operating Time | Total time for the procedure | Start of surgery through end of skin closure in minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Cosmesis | A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing. | Time of surgery through six weeks post partum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Sealy Hospital at University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 17825472 | Background | Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6. |
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Do not plan to share IPD.
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A total of 117 participants signed the consent, 2 participants withdrew. The study terminated early due to the low accrual.
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| ID | Title | Description |
|---|---|---|
| FG000 | Suture Wound Closure | Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand |
| FG001 | Absorbable Staple Wound Closure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2023 |
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Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation
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Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
| Subcuticular monocryl suture manufactured by Ethicon | Device | Under the skin suture placed by hand |
|
| Number of Participants With Composite Wound Complication | Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers | Time of surgery through six weeks post partum |
| Post Operative Pain | Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain. | 5-10 days |
| Number of Adverse Events | Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis | Time of surgery through six weeks post partum |
| Use of Resources | Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures | Time of surgery through six weeks post partum |
| Skin Closure Time in Minutes | The average of minutes it takes for closure of the skin at time of surgery through weeks post partum. | Time of surgery through six weeks post partum |
| 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. |
| 16334959 | Background | Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975. |
| 16566742 | Background | Pineros-Fernandez A, Salopek LS, Rodeheaver PF, Drake DB, Edlich RF, Rodeheaver GT. A revolutionary advance in skin closure compared to current methods. J Long Term Eff Med Implants. 2006;16(1):19-27. doi: 10.1615/jlongtermeffmedimplants.v16.i1.30. |
| 22037686 | Background | Nitsche J, Howell C, Howell T. Skin closure with subcuticular absorbable staples after cesarean section is associated with decreased analgesic use. Arch Gynecol Obstet. 2012 Apr;285(4):979-83. doi: 10.1007/s00404-011-2121-5. Epub 2011 Oct 30. |
| 27632411 | Background | Schrufer-Poland TL, Ruiz MP, Kassar S, Tomassian C, Algren SD, Yeast JD. Incidence of wound complications in cesarean deliveries following closure with absorbable subcuticular staples versus conventional skin closure techniques. Eur J Obstet Gynecol Reprod Biol. 2016 Nov;206:53-56. doi: 10.1016/j.ejogrb.2016.07.501. Epub 2016 Aug 3. |
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Suture Wound Closure | Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand |
| BG001 | Absorbable Staple Wound Closure | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Operating Time | Total time for the procedure | Posted | Mean | Standard Deviation | Minutes | Start of surgery through end of skin closure in minutes |
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| Secondary | Wound Cosmesis | A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing. | Posted | Mean | Standard Deviation | score on a scale | Time of surgery through six weeks post partum |
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| Secondary | Number of Participants With Composite Wound Complication | Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers | Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers | Posted | Count of Participants | Participants | Time of surgery through six weeks post partum |
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| Secondary | Post Operative Pain | Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain. | Posted | Mean | Standard Deviation | Units on a scale | 5-10 days |
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| Secondary | Number of Adverse Events | Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis | Posted | Count of Participants | Participants | Time of surgery through six weeks post partum |
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| Secondary | Use of Resources | Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures | Patients who had follow up who were sent to triage for evaluation | Posted | Count of Participants | Participants | Time of surgery through six weeks post partum |
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| Secondary | Skin Closure Time in Minutes | The average of minutes it takes for closure of the skin at time of surgery through weeks post partum. | Posted | Mean | Standard Deviation | minutes | Time of surgery through six weeks post partum |
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baseline until the end of the study, up to 6 weeks 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 Wound Closure | Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon. Subcuticular monocryl suture manufactured by Ethicon: Under the skin suture placed by hand | 0 | 59 | 0 | 59 | 0 | 59 |
| EG001 | Absorbable Staple Wound Closure | Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical. INSORB: subcuticular stapling device: Under the skin stapling device that delivers absorbable staples | 0 | 56 | 0 | 56 | 0 | 56 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brett Goldman | University of Texas Medical Branch | 9542632359 | brettryangoldman@gmail.com |
| Jun 28, 2024 |
| Prot_SAP_000.pdf |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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