Skin Closures at Cesarean Delivery, Glue vs Subcuticular Sutures.
NCT ID: NCT04371549
Last Updated: 2022-11-22
Study Results
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Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2020-08-25
2021-03-01
Brief Summary
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Detailed Description
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To date, there have been no randomized clinical trials comparing skin closure with glue to sutures using the Patient and Observer Scar Assessment Scale (POSAS). The POSAS is a validated and reliable instrument that is practical for assessing scars . It is comprehensive and correlates well with patient ratings. The Observer Scar Assessment Scale rates 5 variables: vascularity, pigmentation, thickness, relief, and pliability. Each variable is ranked from 1-10, with 1 representing normal skin. Ratings are summed to obtain a total score ranging from 5-50. The Patient Scar Assessment Scale consists of 6 items: scar-related pain, itchiness, color, stiffness, thickness, and irregularity. Each item is ranked from 1-10, with 1 representing normal skin. Total score ranges from 6-60.
Previous studies regarding skin closure with glue were small, retrospective, and included mixed populations and varying surgical techniques. Therefore, clear, conclusive recommendations are lacking.
Dermabond® is a liquid monomeric (2-octyl cyanoacrylate) formulation that undergoes an exothermic reaction upon exposure to moisture, changing to polymers that form a strong tissue bond. The wound will not be dressed with an abdominal pad or adhesive tape according to manufacturer's instructions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glue
Skin closure after cesarean section using glue
Glue (Dermabond®; Ethicon, Somerville, NJ).
Arm 1: Skin after cesarean section will be closed by glue
Monocryl
Skin closure after cesarean section using running subcuticular sutures using synthetic monofilament
Monocryl
Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament
Interventions
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Glue (Dermabond®; Ethicon, Somerville, NJ).
Arm 1: Skin after cesarean section will be closed by glue
Monocryl
Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament
Eligibility Criteria
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Inclusion Criteria
* BMI: 18.5 - 29.9 kg/m2.
* Gestational Age: term pregnancy (≥ 37 weeks) and viable fetus.
* Scheduled to undergo elective lower segment CD (category 4 CD).
* Hemoglobin level: ≥ 10 gm/dl.
Exclusion Criteria
* Emergency CD (category 1, 2 and 3 CD).
* Clinical signs of infection at the time of CD.
* Medical disorder (Diabetes, Hypertension, Cardiac, Hepatic or renal disorder).
* Uterine anomalies (e.g., septum, Mullerian anomalies or fibroids).
* Previous CD not using Pfannenstiel method (e.g., midline incision).
* Known hypersensitivity to any of the suture materials or glue used in the protocol, or any disorders requiring chronic corticosteroids or immune suppressants.
* History of surgical site infection after previous CD.
20 Years
40 Years
FEMALE
No
Sponsors
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Ain Shams Maternity Hospital
OTHER
Responsible Party
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Ahmed Mohammed Elmaraghy
Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university
Principal Investigators
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Mahmoud K Mohammed, M.B.B.Ch
Role: PRINCIPAL_INVESTIGATOR
AinShams university
Locations
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AinShams university maternity hospital
Cairo, , Egypt
Countries
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References
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Altman R, Bosch B, Brune K, Patrignani P, Young C. Advances in NSAID development: evolution of diclofenac products using pharmaceutical technology. Drugs. 2015 May;75(8):859-77. doi: 10.1007/s40265-015-0392-z.
ACOG Practice Bulletin No. 199 Summary: Use of Prophylactic Antibiotics in Labor and Delivery. Obstet Gynecol. 2018 Sep;132(3):798-800. doi: 10.1097/AOG.0000000000002834.
Bhende S, Rothenburger S, Spangler DJ, Dito M. In vitro assessment of microbial barrier properties of Dermabond topical skin adhesive. Surg Infect (Larchmt). 2002 Fall;3(3):251-7. doi: 10.1089/109629602761624216.
Blanchette H. The rising cesarean delivery rate in America: what are the consequences? Obstet Gynecol. 2011 Sep;118(3):687-690. doi: 10.1097/AOG.0b013e318227b8d9.
Bruns TB, Worthington JM. Using tissue adhesive for wound repair: a practical guide to dermabond. Am Fam Physician. 2000 Mar 1;61(5):1383-8.
Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.
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.
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.
Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
Siddiqui DS, Lacuna EM, Chen HY, Chauhan SP. Skin closure of pfannenstiel incision with dermabond, staples, or suture during cesarean delivery: experience of a single attending. Am J Perinatol. 2013 Mar;30(3):219-24. doi: 10.1055/s-0032-1323583. Epub 2012 Aug 8.
Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. doi: 10.1056/NEJM199710163371607. No abstract available.
Singer AJ, Quinn JV, Clark RE, Hollander JE; TraumaSeal Study Group. Closure of lacerations and incisions with octylcyanoacrylate: a multicenter randomized controlled trial. Surgery. 2002 Mar;131(3):270-6. doi: 10.1067/msy.2002.121377.
Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.
van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
Other Identifiers
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2
Identifier Type: -
Identifier Source: org_study_id
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