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Based on results of an interim analysis, the study was halted for futility
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue Adhesive | Experimental | Tissue Adhesive will be placed over subcuticular suture closure. |
|
| Steri-Strips | Active Comparator | Sterile strips will be placed over subcuticular suture closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tissue Adhesive | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Complication | Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation | 6-8 weeks from cesarean delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Readmission for Wound Complication | Within 8 weeks from cesarean delivery | |
| Satisfaction With Cesarean Scar | The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Plunkett, MD | Endeavor Health | Principal Investigator |
| Lena Braginsky, MD | Endeavor Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| NorthShore Evanston Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18034920 | Background | Souza EC, Fitaroni RB, Januzelli DM, Macruz HM, Camacho JC, Souza MR. Use of 2-octyl cyanoacrylate for skin closure of sternal incisions in cardiac surgery: observations of microbial barrier effects. Curr Med Res Opin. 2008 Jan;24(1):151-5. doi: 10.1185/030079908x253807. | |
| 25479008 | Background | Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2. |
| Label | URL |
|---|---|
| Patient Scar Scale | View source |
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All of the individual participant data collected during the trial, after deidentification, will be available upon request.
Available immediately after publication with no end date.
Investigators may request data by contacting lbraginsky@northshore.org
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| ID | Title | Description |
|---|---|---|
| FG000 | Tissue Adhesive | Tissue Adhesive will be placed over subcuticular suture closure. Tissue Adhesive |
| FG001 | Sterile Strips | Sterile strips will be placed over subcuticular suture closure. Sterile strips |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tissue Adhesive | Tissue Adhesive will be placed over subcuticular suture closure. Tissue Adhesive |
| BG001 | Steri-Strips | Sterile strips will be placed over subcuticular suture closure. Sterile strips |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Complication | Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation | Posted | Count of Participants | Participants | 6-8 weeks from cesarean delivery |
|
|
8 weeks
Patients were contacted and medical records reviewed to assess for adverse events
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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 | Tissue Adhesive | Tissue Adhesive will be placed over subcuticular suture closure. Tissue Adhesive |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lena Braginsky | NorthShore University HealthSystem | 2245952705 | lena.braginsky.mfm@gmail.com |
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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 | May 19, 2017 | Jul 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D053831 | Surgical Fixation Devices |
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| Sterile strips | Device |
|
|
| 6-8 weeks from cesarean delivery |
| Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | The investigators will review medical records to assess for ambulatory visits for wound complaints | Within 8 weeks of delivery |
| Operative Time | The investigators will review operative records to assess operative time | At time of delivery |
| Number of Participants Requiring Antibiotic Treatment for Wound Complication | The investigators will review medical records to assess for antibiotic prescriptions for wound complications | Within 8 weeks of delivery |
| Evanston |
| Illinois |
| 60201 |
| United States |
| NorthShore Highland Park Hospital | Highland Park | Illinois | 60035 | United States |
| 20878942 | Background | Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214. |
| 25004353 | Background | Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384. |
| 22108085 | Background | Tipton AM, Cohen SA, Chelmow D. Wound infection in the obese pregnant woman. Semin Perinatol. 2011 Dec;35(6):345-9. doi: 10.1053/j.semperi.2011.05.020. |
| 28796687 | Background | Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200. |
| 28153666 | Background | Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30. |
| 31306319 | Derived | Braginsky L, Javellana M, Cleveland E, Elue R, Wang C, Boyle D, Plunkett BA. Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):295-301. doi: 10.1097/AOG.0000000000003367. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Nulliparity | Count of Participants | Participants |
|
| Prior cesarean delivery | Count of Participants | Participants |
|
| Body mass index at delivery | Median | Inter-Quartile Range | kg/m^2 |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Hypertensive disorders | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Immunocompromised | Count of Participants | Participants |
|
| Cesarean delivery while in labor | Count of Participants | Participants |
|
| Chorioamnionitis | Count of Participants | Participants |
|
| Blood loss | Median | Inter-Quartile Range | mL |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Readmission for Wound Complication | Posted | Count of Participants | Participants | Within 8 weeks from cesarean delivery |
|
|
|
| Secondary | Satisfaction With Cesarean Scar | The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups. Please see website in links section for more details on this assessment tool. | Completion of the modified Patient Scar Assessment Scale was accomplished in 203/252 (80.6%) of women in the tissue adhesive group and 203/252 (80.6%) of women in the sterile strips group. | Posted | Median | Inter-Quartile Range | score on a scale | 6-8 weeks from cesarean delivery |
|
|
|
| Secondary | Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication | The investigators will review medical records to assess for ambulatory visits for wound complaints | Posted | Count of Participants | Participants | Within 8 weeks of delivery |
|
|
|
| Secondary | Operative Time | The investigators will review operative records to assess operative time | Posted | Median | Inter-Quartile Range | min | At time of delivery |
|
|
|
| Secondary | Number of Participants Requiring Antibiotic Treatment for Wound Complication | The investigators will review medical records to assess for antibiotic prescriptions for wound complications | Posted | Count of Participants | Participants | Within 8 weeks of delivery |
|
|
|
| 0 |
| 252 |
| 0 |
| 252 |
| 0 |
| 252 |
| EG001 | Sterile Strips | Sterile strips will be placed over subcuticular suture closure. Sterile strips | 0 | 252 | 0 | 252 | 0 | 252 |
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| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |