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| ID | Type | Description | Link |
|---|---|---|---|
| SJ-162 | Other Identifier | The Danish National Committee on Biomedical Research Ethics |
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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Region Zealand | OTHER |
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The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st c-section, no previous lower abdominal surgery - s.l. | Experimental |
| |
| Woman with previous ceasarean section - staples left | Experimental |
| |
| 1st c-section, no previous lower abdominal surgery | Experimental |
| |
| Woman with previous ceasarean section | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staples left, subcuticular suture right | Procedure | Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side. |
| Measure | Description | Time Frame |
|---|---|---|
| Preferred side of the caesarean section scar | Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference. | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in pain between the two ends of the scar | Difference in painscore between the two ends of the scar 1st and 7th postoperative day. Pain is registered by a score on a vas-scale from 0-10. | 1 and 7 days postoperatively |
| The difference in pain between the two ends of the scar |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Jørgen Secher, Profesoor, M.D. | Department of Obstetrics, Hvidovre Hospital | Study Chair |
| Anna J. M. Aabakke, M.D. | Department of Gynaechology and Obstetrics, Holbæk Sygehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynaechology and Obstetrics, Holbæk Sygehus | Holbæk | 4300 | Denmark |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D010149 | Pain, Postoperative |
| D007239 | Infections |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| Subcuticular suture left side and staples right | Procedure | Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side. |
|
Difference in painscore between the two ends of the scar 3 and 6 months postoperatively. Pain is registered by a score on a vas-scale from 0-10. |
| 3 and 6 months postoperatively |
| Pain in the two ends of the scar | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively. | 1 and 7 days postoperatively |
| Pain in the two ends of the scar | Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively. | 3 and 6 months postoperatively |
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 7 days postoperatively |
| Infection | The rate of postoperative infection and what side of the scar - right or left -that is infected. | 3 and 6 months postoperatively |
| Cosmetic objective evaluation of the two ends of the scar | Evaluation of the right and left side of the scar respectively by two blinded doctors using the Singer's "scar evaluation scale" . Difference in Singer's score between the two ends of the scar. | 6 months postoperatively |
| Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section. | Primay and Secondary outcome measures are compared in the two groups of patients. | 6 months |
| Background |
| CORONIS Trial Collaborative Group. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial. BMC Pregnancy Childbirth. 2007 Oct 22;7:24. doi: 10.1186/1471-2393-7-24. |
| 19646316 | Background | Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X. |
| 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. |
| 18090752 | Background | Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10. |
| 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. |
| 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. |
| 16822582 | Background | Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5. |
| 20417924 | Background | Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24. |
| 24084548 | Derived | Aabakke AJM, Krebs L, Pipper CB, Secher NJ. Subcuticular suture compared with staples for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):878-884. doi: 10.1097/AOG.0b013e3182a5f0c3. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |