Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02055794
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Optimal Healing After Laceration Repair Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004659', 'term': 'Enbucrilate'}], 'ancestors': [{'id': 'D003487', 'term': 'Cyanoacrylates'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D014014', 'term': 'Tissue Adhesives'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2014-02-04', 'studyFirstSubmitQcDate': '2014-02-04', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-perceived pain', 'timeFrame': 'Post-partum (PPD), 2 weeks, 6 weeks and 3 months.', 'description': 'The 2 week and 3 month measurements will be done via email, web or mailed questionnaire. Pain will be measured using 3 pain scales: a validated 100-mm Visual Analogue Scale (VAS) (anchors: 0 = none, 100 mm = worst imaginable), a 6 point Likert scale and the McGill pain questionnaire short form.'}], 'secondaryOutcomes': [{'measure': 'Wound assessment', 'timeFrame': '6 weeks post-partum', 'description': 'Wounds will be assessed through wound evaluation (6 weeks post-partum), wound complications (wound infection, dehiscence, granulation tissue), need for additional interventions (silver nitrate, revision of wound) and assessment of wound appearance using a validated 100-mm VAS (anchors: 0 = worst scar, 100 mm = best scar).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['perineal wound', 'perineal tear', 'perineum', 'pain', 'childbirth'], 'conditions': ['Neuralgia, Perineal']}, 'descriptionModule': {'briefSummary': 'The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain.\n\nNull hypothesis: There will be no difference in patient pain among the three different methods for second degree perineal wound repair.', 'detailedDescription': 'At the University of Michigan, there are currently two standard techniques for repairing second-degree perineal lacerations that differ only in management of the perineal skin :\n\n1. Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl suture\n2. Closure of the deep tissues with a continuous 3-0 Vicryl suture and reapproximation of, but not suture-closure of the perineal skin.\n\nThe primary goal of our study is to compare patient pain amongst the following three perineal skin repair techniques after second degree laceration:\n\n1. Perineal skin closure with suturing\n2. Not suturing the perineal skin\n3. Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue.\n\nIn all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0 Vicryl suture, as is current standard practice.\n\nAim: To assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women 18 years old - 45 years old\n* Immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery\n* \\> 32 weeks gestation\n* Second degree laceration from spontaneous tear or midline episiotomy\n* Proficient in English\n\nExclusion Criteria:\n\n* \\<18 years old and \\>45 years old\n* Delivery by Cesarean\n* 1st, 3rd or 4th degree lacerations\n* Induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown\n* Known allergy to cyanoacrylate or formaldehyde\n* Systemic infections, uncontrolled diabetes (women with well-controlled pre-gestational or gestational diabetes will not be excluded)\n* History of connective tissue disorders (e.g. Scleroderma, Ehlers Danlos)\n* Chronic use of steroids\n* Currently under treatment for cancer\n* Previous radiation to the pelvis\n* Any organ transplants\n* History of neurological conditions including multiple sclerosis, stroke, Alzheimer's, or other dementias\n* Not proficient in the English language"}, 'identificationModule': {'nctId': 'NCT02055794', 'acronym': 'PALS', 'briefTitle': 'Promoting Optimal Healing After Laceration Repair Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Promoting Optimal Healing After Laceration Repair Study - PALS Study', 'orgStudyIdInfo': {'id': 'HUM00079230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Suturing of the perineal skin', 'description': 'Suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.', 'interventionNames': ['Procedure: Suturing of the perineal skin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No suturing of the perineal skin', 'description': 'No suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.', 'interventionNames': ['Procedure: No suturing of the perineal skin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closing perineal skin with surgical glue', 'description': 'Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture.', 'interventionNames': ['Procedure: Closing perineal skin with surgical glue']}], 'interventions': [{'name': 'Suturing of the perineal skin', 'type': 'PROCEDURE', 'armGroupLabels': ['Suturing of the perineal skin']}, {'name': 'Closing perineal skin with surgical glue', 'type': 'PROCEDURE', 'otherNames': ['n-Butyl 2-cyanoacrylate', 'Indermil®', 'surgical glue'], 'armGroupLabels': ['Closing perineal skin with surgical glue']}, {'name': 'No suturing of the perineal skin', 'type': 'PROCEDURE', 'armGroupLabels': ['No suturing of the perineal skin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Dee Fenner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Obstetrics & Gynecology', 'investigatorFullName': 'Dee Fenner', 'investigatorAffiliation': 'University of Michigan'}}}}