Dressing Versus Glue (2-Octyl Cyanoacrylate) for Coverage of the Skin Incision After Closure During Cesarean Delivery

NCT02323711 | Withdrawn

• 1 other identifier: WCHN/IRB 13-56
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is investigating the relative risks and benefits of using two common materials for coverage of the skin incision at cesarean delivery. We will perform the first prospective and the first randomized controlled trial examining the use of a standard postoperative dressing versus skin glue for coverage of the closed skin incision after cesarean delivery. The hypothesis is that using skin glue for coverage of the incision will be associated with decreased wound complications and increased patient satisfaction.

Conditions

Pregnant Women; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Any Significant complications

  the primary outcome of the study will be a composite outcome of any significant complications including wound separation, wound infection, symptomatic seroma or hematoma, or readmission for a wound complication within 30 days postoperatively. This data is gathered from the subject's medical record and from the Discharging Resident Questionnaire.

  30 Days following cesarean delivery.

Secondary Outcomes (1)

• Minor Complications and/or Patient Dissatisfaction

  30 Days following cesarean delivery

Study Arms (2)

Control

NO INTERVENTION

This group would be receiving the standard of care. The subject would receive the standard dressing applied by a member of the surgical team in the standard fashion as follows: The closed incision will be covered first with a primary dressing consisting of a nonadherent, composite dressing (Telfa), which is covered with a secondary dressing consisting of an Army Battle Dressing (ABD), before removal of the sterile surgical drapes. This dressing is then held in place with an adhesive fabric tape, currently Mefix tape, which is typically applied by the surgical scrub tech.

2-octyl cyanoacrylate

EXPERIMENTAL

This group would receive the experimental treatment. If allocated to coverage with glue, no dressing is placed. After closure of the incision with suture or staples, the incision is patted dry under sterile conditions. The incision is then covered longitudinally by a member of the surgical team with a thick layer of skin glue dispensed from 1 tube of surgical skin glue (2-octyl cyanoacrylate, currently using brand: Derma+Flex QS). The glue is then allowed to dry before the sterile surgical drapes are removed.

Device: 2-octyl cyanoacrylate

Interventions

2-octyl cyanoacrylate DEVICE

If the subject is allocated to the experimental group, they would receive 2-octyl cyanoacrylate in place of a primary dressing consisting of their non-adherent composite dressing (Tefla) and a secondary dressing of Army Battle Dressing (ABD).

Also known as: Derma+flex QS

2-octyl cyanoacrylate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women admitted to Labor and Delivery for scheduled cesarean section, for labor, or for induction of labor
• Age \>/= 18 years
• All gestational ages
• All numbers of gestations
• All fetal presentations

You may not qualify if:

• Patient is under 18 years of age.
• Intrauterine fetal death, excluded simply for social reasons concerning consenting the patient for the study during upsetting circumstances.
• Patient is NOT fluent in English, Spanish, or Portuguese.
• Urgent or emergent cesarean delivery for fetal distress that develops before the patient is approached for consent
• Patient incompetent to provide independent informed consent.
• Patient has a known allergy to Glue, Tape, Cyanoacrylate, and/or Formaldehyde.

Sponsors & Collaborators

• Danbury Hospital: lead

Related Publications (8)

• Romero P, Frongia G, Wingerter S, Holland-Cunz S. Prospective, randomized, controlled trial comparing a tissue adhesive (Dermabond) with adhesive strips (Steri-Strips) for the closure of laparoscopic trocar wounds in children. Eur J Pediatr Surg. 2011 May;21(3):159-62. doi: 10.1055/s-0030-1270458. Epub 2011 Jan 31.

  PMID: 21283958 BACKGROUND

• Ong CC, Jacobsen AS, Joseph VT. Comparing wound closure using tissue glue versus subcuticular suture for pediatric surgical incisions: a prospective, randomised trial. Pediatr Surg Int. 2002 Sep;18(5-6):553-5. doi: 10.1007/s00383-002-0728-0. Epub 2002 Jun 14.

  PMID: 12415411 BACKGROUND

• Cho J, Harrop J, Veznadaroglu E, Andrews DW. Concomitant use of computer image guidance, linear or sigmoid incisions after minimal shave, and liquid wound dressing with 2-octyl cyanoacrylate for tumor craniotomy or craniectomy: analysis of 225 consecutive surgical cases with antecedent historical control at one institution. Neurosurgery. 2003 Apr;52(4):832-40; discussion 840-1. doi: 10.1227/01.neu.0000054219.35102.b4.

  PMID: 12657178 BACKGROUND

• Rajimwale A, Golden BK, Oottomasathien S, Krishnamurthy M, Ullrich NO, Koyle MA. Octyl-2-cyanoacrylate as a routine dressing after open pediatric urological procedures. J Urol. 2004 Jun;171(6 Pt 1):2407-8. doi: 10.1097/01.ju.0000125221.50141.33.

  PMID: 15126862 BACKGROUND

• 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: 16079683 BACKGROUND

• Singer AJ, Hollander JE, Valentine SM, Turque TW, McCuskey CF, Quinn JV. Prospective, randomized, controlled trial of tissue adhesive (2-octylcyanoacrylate) vs standard wound closure techniques for laceration repair. Stony Brook Octylcyanoacrylate Study Group. Acad Emerg Med. 1998 Feb;5(2):94-9. doi: 10.1111/j.1553-2712.1998.tb02590.x.

  PMID: 9492126 BACKGROUND

• 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: 22875661 BACKGROUND

• 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.

  PMID: 24084548 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Maternal Fetal Medicine and Medical Director, Labor and Delivery, Department of Obstetrics, Gynecology, and Reproductive Services

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 10, 2015

Record last verified: 2015-03