An interventional study of 2-octyl cyanoacrylate in Pregnant Women and Cesarean Section, sponsored by Danbury Hospital. Withdrawn. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by Danbury Hospital · Not applicable and Interventional
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.
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.
Danbury Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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
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
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.
Time frame: 30 Days following cesarean delivery.
Minor Complications and/or Patient Dissatisfaction
Secondary outcomes will include problems with the periwound skin including blistering or skin tears, as well as pain or itching of the wound and periwound skin, narcotic use during the hospitalization, and overall patient satisfaction with the incision at the time of discharge. This data is gathered from the subject's medical record and the Patient Discharge Questionnaire, the Patient Follow-Up Questionnaire, and the Physician Follow-Up Questionnaire(if applicable).
Time frame: 30 Days following cesarean delivery
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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