Clinical trial NCT04622267: Barbed Suture for Hysterotomy Closure During Cesarean Section
Official title: Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterotomy
Keywords: Barbed suture
Blood loss
Hysterotomy
Cesarean section
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.

Study participation will last 1 year and will include the following research procedures :

1. Randomization to barbed suture vs. standard suture
2. Collection of data for primary and secondary outcomes
3. Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.

Detailed description: This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
* age 18-64.

Exclusion Criteria:

* Multifetal gestations
* Placenta previas
* Pre-term patients
* Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)
* Patients undergoing an unplanned or emergency cesarean section

Primary outcomes:
measure: Quantitative Blood Loss
timeFrame: Day 1, At delivery
Secondary outcomes:
measure: Time for Hysterotomy Closure
timeFrame: Day 1, At delivery
measure: Number of Participants Who Need Additional Hemostatic Sutures
timeFrame: Day 1, At delivery
measure: Number of Hemostatic Sutures
timeFrame: Day 1, At delivery
measure: Number of Participants With Surgical Site Infections (SSI)
timeFrame: Day 1, At delivery
measure: Rate of Surgical Site Infections (SSI)
timeFrame: 6 weeks
measure: Change in Pain Score
timeFrame: Day 1, At delivery and 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai Hospital
name: Calvin Lambert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfuntner A, Wier LM, Stocks C. Most Frequent Procedures Performed in U.S. Hospitals, 2010. 2013 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #149. Available from http://www.ncbi.nlm.nih.gov/books/NBK132428/
citation: Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.