Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01217567
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preferred side of the caesarean section scar', 'timeFrame': '6 months postoperatively', 'description': 'Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.'}], 'secondaryOutcomes': [{'measure': 'The difference in pain between the two ends of the scar', 'timeFrame': '1 and 7 days postoperatively', 'description': '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.'}, {'measure': 'The difference in pain between the two ends of the scar', 'timeFrame': '3 and 6 months postoperatively', 'description': '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.'}, {'measure': 'Pain in the two ends of the scar', 'timeFrame': '1 and 7 days postoperatively', 'description': 'Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 1 and 7 days postoperatively.'}, {'measure': 'Pain in the two ends of the scar', 'timeFrame': '3 and 6 months postoperatively', 'description': 'Pain in the two ends of the scar registered by a score on a vas-scale from 0-10 3 and 6 months postoperatively.'}, {'measure': 'Infection', 'timeFrame': '7 days postoperatively', 'description': 'The rate of postoperative infection and what side of the scar - right or left -that is infected.'}, {'measure': 'Infection', 'timeFrame': '3 and 6 months postoperatively', 'description': 'The rate of postoperative infection and what side of the scar - right or left -that is infected.'}, {'measure': 'Cosmetic objective evaluation of the two ends of the scar', 'timeFrame': '6 months postoperatively', 'description': '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.'}, {'measure': 'Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.', 'timeFrame': '6 months', 'description': 'Primay and Secondary outcome measures are compared in the two groups of patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cicatrix', 'cesarean section', 'sutures', 'surgical staples', 'postoperative pain', 'Infection'], 'conditions': ['Cesarean Section', 'Cicatrix']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'The CAESAR study: http://www.npeu.ox.ac.uk/caesar'}, {'pmid': '14520211', 'type': 'BACKGROUND', 'citation': "Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8."}, {'pmid': '18336721', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19646316', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9350017', 'type': 'BACKGROUND', 'citation': 'Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.'}, {'pmid': '17825472', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18090752', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19254586', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12804476', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16822582', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20417924', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24084548', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. An objective evaluation of the two ends of the scar 6 months postoperatively.\n2. A patient evaluation of the two ends of the scar 6 months postoperatively.\n3. The difference in pain in the two ends of the scar 1 day postoperatively (blinded).\n4. The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.\n5. The rate of infection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started.\n* Woman who speak and understand Danish\n* Woman who can give informed consent.\n\nExclusion Criteria:\n\n* Level I or II caesarean section (ordered less than 30 min. before surgery is started).\n* Diabetics (this does not include gestational diabetes).\n* Infection\n* Regular treatment with immunosuppressives\n* Alcohol or drug abuse\n* Age under 18\n* Chronic pain disease eg fibromyalgia, rheumatoid arthritis\n* BMI over 35\n* Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).'}, 'identificationModule': {'nctId': 'NCT01217567', 'briefTitle': 'Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Holbaek Sygehus'}, 'officialTitle': "Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section: A Prospective Randomized Single-blinded Case-Control Study With the Case as it's Own Control.", 'orgStudyIdInfo': {'id': 'Cicatricestudiet'}, 'secondaryIdInfos': [{'id': 'SJ-162', 'type': 'OTHER', 'domain': 'The Danish National Committee on Biomedical Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1st c-section, no previous lower abdominal surgery - s.l.', 'interventionNames': ['Procedure: Staples left, subcuticular suture right']}, {'type': 'EXPERIMENTAL', 'label': 'Woman with previous ceasarean section - staples left', 'interventionNames': ['Procedure: Staples left, subcuticular suture right']}, {'type': 'EXPERIMENTAL', 'label': '1st c-section, no previous lower abdominal surgery', 'interventionNames': ['Procedure: Subcuticular suture left side and staples right']}, {'type': 'EXPERIMENTAL', 'label': 'Woman with previous ceasarean section', 'interventionNames': ['Procedure: Subcuticular suture left side and staples right']}], 'interventions': [{'name': 'Staples left, subcuticular suture right', 'type': 'PROCEDURE', 'description': 'Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.', 'armGroupLabels': ['1st c-section, no previous lower abdominal surgery - s.l.', 'Woman with previous ceasarean section - staples left']}, {'name': 'Subcuticular suture left side and staples right', 'type': 'PROCEDURE', 'description': 'Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.', 'armGroupLabels': ['1st c-section, no previous lower abdominal surgery', 'Woman with previous ceasarean section']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Department of Gynaechology and Obstetrics, Holbæk Sygehus', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}], 'overallOfficials': [{'name': 'Niels Jørgen Secher, Profesoor, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Obstetrics, Hvidovre Hospital'}, {'name': 'Anna J. M. Aabakke, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gynaechology and Obstetrics, Holbæk Sygehus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Holbaek Sygehus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Region Zealand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anna Aabakke, M.D.', 'investigatorFullName': 'Anna Aabakke', 'investigatorAffiliation': 'Holbaek Sygehus'}}}}