Clinical trial NCT02323711: Dressing Versus Glue (2-Octyl Cyanoacrylate) for Coverage of the Skin Incision After Closure During Cesarean Delivery
Official title: A Randomized Controlled Trial of Dressing Versus Glue (2-Octyl Cyanoacrylate) for Coverage of the Skin Incision After Closure During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnant Women
Cesarean Section
Lead sponsor: Danbury Hospital
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: Given the plethora of literature regarding technical aspects of performing cesarean delivery, and given the large number of procedures performed each year and available for prospective trials (approximately 700 cesarean deliveries per year at Danbury Hospital), only quality level I evidence is broadly considered influential in this area of research. Therefore we propose a RCT for incision coverage with dressing versus glue at cesarean delivery.

On admission to L\&D for schedule cesarean section, or on admission to L\&D for labor, patients will be asked to participate by a Trial Coordinator or the admitting Obstetrics and Gynecology resident physician. Patients admitted for labor will be asked to participate given the possibility that they may ultimately require cesarean delivery, and because using only patients admitted for scheduled cesarean delivery would eliminate urgent and emergent cesarean deliveries from the trial, and therefore decrease the generalizability of the trial results to general obstetrics practice.

When consented and the patient undergoes cesarean delivery, the patient's surgeon will decide if skin closure will be performed by placement of staples or suture. The circulating nurse in the OR will open one of a set of sequentially numbered, opaque sealed envelopes (SNOSE) to indicate the patient's allocation for coverage of the incision with a dressing or glue. The circulating nurse will then tell the surgeon to which group the patient has been allocated.

Before closure of the incision, care is taken to ensure hemostasis of the subcutaneous tissues and skin edges. If the subcutaneous tissues are \> 2 cm thick, this tissue layer should be approximated before closure of the skin as is currently a level I evidence-based recommendation based on multiple RCTs and promoted by current clinical guidelines. Choice of suture material and needle for the running subcuticular closure, or use of staples for closure, are per the surgeon's preference.

If allocated to coverage with dressing, the standard dressing will be 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.

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.

Staples placed for incision closure are routinely removed on the day of discharge. Sutures placed for skin closure are absorbable and are therefore not removed.

Eligibility criteria: Inclusion Criteria:

* 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
* All maternal and fetal medical or surgical comorbidities are included except as listed in the exclusion criteria

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Any Significant complications
timeFrame: 30 Days following cesarean delivery.
Secondary outcomes:
measure: Minor Complications and/or Patient Dissatisfaction
timeFrame: 30 Days following cesarean delivery
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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