NCT04371549

Brief Summary

The optimal choice of skin closure at cesarean delivery has not yet been determined. This study will compare wound complications and scar healing following cesarean delivery between 2 methods of skin closure: glue (Dermabond®; Ethicon, Somerville, NJ) and monofilament (Monocryl®; Ethicon) epidermal sutures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 27, 2020

Last Update Submit

November 20, 2022

Conditions

Cesarean Wound; Dehiscence

Outcome Measures

Primary Outcomes (2)

  • The Patient and Observer Scar Assessment Scale (POSASv2.0):

    In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer Scale POSASv2.0 are as follows (all parameters should be compared to normal skin at a comparable anatomical site whenever possible):The Patient Scale contains six questions applying to pain, itching, colour, pliability, thickness and relief.Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1' and corresponds to the situation of normal skin (normal pigmentation, no itching etc.), and goes up to the worst imaginable

    one week after cesarean section

  • The Patient and Observer Scar Assessment Scale (POSASv2.0):

    In the POSASv2.0 observers rate vascularity, pigmentation, pliability, thickness, relief and surface area. The directions for use of the different parameters of the Observer scale POSASv2.0 are as follows ( all parameters should be compared to normal skin at a comparable anatomical site whenever possible): The Patient scale contains six questions applying to pain, itching, colour, pliability, thickness and relief. Each of the six items on both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is 1 and correspons to the situation of normal skin( normal pigmentation, no itching etc.) and goes up to the worst imaginable

    one month after cesarean section

Secondary Outcomes (2)

  • Surgeons' satisfaction scale:

    immediately after the procedure

  • Duration of surgery

    in minutes from closure of the subcutaneous fat layer to closure of the skin

Study Arms (2)

Glue

ACTIVE COMPARATOR

Skin closure after cesarean section using glue

Procedure: Glue (Dermabond®; Ethicon, Somerville, NJ).

Monocryl

ACTIVE COMPARATOR

Skin closure after cesarean section using running subcuticular sutures using synthetic monofilament

Procedure: Monocryl

Interventions

Glue (Dermabond®; Ethicon, Somerville, NJ).PROCEDURE

Arm 1: Skin after cesarean section will be closed by glue

Glue
MonocrylPROCEDURE

Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament

Monocryl

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal Age: 20-40 years old.
  • 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.

You may not qualify if:

  • Abnormal placental invasion (e.g., placenta previa).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Egypt

Location

Related Publications (14)

  • 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.

    PMID: 25963327BACKGROUND

  • 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.

    PMID: 30134418BACKGROUND

  • 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.

    PMID: 12542926BACKGROUND

  • 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.

    PMID: 21860302BACKGROUND

  • 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.

    PMID: 10735344BACKGROUND

  • 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.

    PMID: 21195384BACKGROUND

  • 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: 20417924BACKGROUND

  • 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.

    PMID: 28153666BACKGROUND

  • 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.

    PMID: 15253184BACKGROUND

  • 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.

    PMID: 22875661BACKGROUND

  • 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.

    PMID: 9329936BACKGROUND

  • 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.

    PMID: 11894031BACKGROUND

  • 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.

    PMID: 17230080BACKGROUND

  • 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.

    PMID: 16079683BACKGROUND

MeSH Terms

Interventions

Adhesivesoctyl 2-cyanoacrylateglycolide E-caprolactone copolymer

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mahmoud K Mohammed, M.B.B.Ch

    AinShams university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology - faculty of medicine - Ainshams university

Study Record Dates

First Submitted

April 27, 2020

First Posted

May 1, 2020

Study Start

August 25, 2020

Primary Completion

January 31, 2021

Study Completion

March 1, 2021

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

EG(1)