Barbed Sutures for Uterine Prolapse

(BEST Trial)

Overseen By Sachin Vyas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Systemic steroids, Immunosuppressives

Disqualifiers: Pelvic organ cancer, Systemic infection, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Day 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of stitches to improve surgery for uterine prolapse, a condition where the uterus slips out of its normal position. Researchers aim to determine if barbed stitches (barbed delayed absorbable suture) can speed up the surgery while still promoting quick recovery with less pain and bleeding. Participants will receive either barbed or non-barbed stitches during their surgery. The trial seeks individuals with a noticeable vaginal bulge due to prolapse who desire surgical treatment. As an unphased trial, it offers participants the chance to contribute to advancements in surgical techniques for uterine prolapse.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking systemic steroids, immunosuppressive, or immunomodulatory treatments, you may not be eligible if taken recently. Please consult with the trial coordinators for more details.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking systemic steroids or immunosuppressive treatments, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that barbed delayed absorbable sutures are generally safe for surgeries like sacrocolpopexy, which corrects pelvic organ prolapse. Studies have found that patients tolerate these sutures well for over a year, with no major safety issues reported. For example, one study followed 20 patients and found the sutures safe and effective. This group experienced no significant negative effects, suggesting the sutures do not cause harm during surgery or recovery. Overall, these sutures have a good safety record in similar procedures, providing reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using barbed delayed absorbable sutures for treating uterine prolapse because they offer a unique advantage over traditional non-barbed sutures. Barbed sutures have tiny barbs along their length, allowing them to grip tissue more securely without needing knots, which can potentially reduce surgery time and improve recovery. Additionally, these barbs help distribute tension evenly across the tissue, possibly reducing the risk of complications and improving overall surgical outcomes. This innovative approach could lead to better, more efficient management of uterine prolapse compared to current methods.

What evidence suggests that this trial's treatments could be effective for uterine prolapse?

This trial will compare barbed delayed absorbable sutures with non-barbed delayed absorbable sutures for vaginal mesh attachment during sacrocolpopexy surgery. Research has shown that barbed delayed absorbable sutures work well for robotic sacrocolpopexy, a surgery to fix uterine prolapse. One study found that these stitches can cut the time needed to attach the vaginal mesh by half compared to regular stitches, making surgeries shorter with less pain and quicker recovery. Another study found that these stitches are safe and effective for at least a year in women who had the surgery. Overall, these stitches have been linked to successful results in treating pelvic organ prolapse. ^{1 2 3 6 7}

Who Is on the Research Team?

Katherine L Woodburn, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 21 with bothersome vaginal bulge, eligible for laparoscopic or robotic sacrocolpopexy due to uterine prolapse. They must not have poorly controlled diabetes, be unable to maintain certain positions during surgery, or have medical conditions preventing surgery. Women who've had prior mesh repairs or pelvic organ cancer, those on recent steroids/immunosuppressants, and with sensitivity to polypropylene are excluded.

Inclusion Criteria

I want surgery for my prolapse symptoms.

I have a prolapse that extends to or beyond the vaginal opening.

Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher

Exclusion Criteria

I am unable to understand or participate in the study procedures.

I do not have any active infections, including UTIs or tissue necrosis.

I need surgery to fix a rectal prolapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive sacrocolpopexy with either barbed or non-barbed delayed absorbable sutures for vaginal mesh attachment

Day 1

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and adverse outcomes, including mesh exposure and quality of life changes

1 year

Multiple visits (in-person and virtual)

Adverse Outcome Monitoring

Adverse outcomes are assessed and classified according to the Clavien-Dindo system

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Barbed delayed absorbable suture
• Non-barbed delayed absorbable suture

Trial Overview The study compares two types of sutures used in minimally invasive sacrocolpopexy: non-barbed delayed absorbable suture versus barbed delayed absorbable suture. The goal is to see if one results in faster operation times without compromising patient outcomes like recovery speed and hospital stay duration.

How Is the Trial Designed?

Group I: Non-barbed delayed absorbable suture Experimental Treatment 1 Intervention

Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Group II: Barbed delayed absorbable suture Experimental Treatment 1 Intervention

Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Barbed delayed absorbable suture is already approved in United States, European Union for the following indications:

Approved in United States as Barbed delayed absorbable suture for:

• Sacrocolpopexy
• Vaginal mesh attachment

Approved in European Union as Barbed delayed absorbable suture for:

• Sacrocolpopexy
• Vaginal mesh attachment

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The use of absorbable barbed wire (V-Loc) sutures during laparoscopic myomectomy significantly reduced operative time (51 minutes) and suturing time (9.9 minutes) compared to traditional continuous sutures (58 minutes and 15.8 minutes, respectively).

Patients in the V-Loc group experienced significantly less intraoperative bleeding and a smaller drop in hemoglobin levels, indicating improved safety and efficacy in surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new type of absorbable barbed suture for use in laparoscopic myomectomy. Angioli, R., Plotti, F., Montera, R., et al.[2016]

In a study of 150 women undergoing laparoscopic sacrocervicopexy, late absorbable sutures were found to be non-inferior to non-absorbable sutures, achieving a 100% success rate in prolapse correction at 12 months.

The use of late absorbable sutures resulted in a lower rate of mesh erosion (0%) compared to non-absorbable sutures (4%), suggesting a potential safety advantage without compromising surgical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial. Tagliaferri, V., Ruggieri, S., Taccaliti, C., et al.[2023]

The use of barbed sutures for vaginal mesh attachment during laparoscopic and robotic sacrocolpopexy was significantly faster, taking about 29 minutes compared to 42 minutes for non-barbed sutures, indicating greater efficiency in the surgical procedure.

Despite the faster attachment time with barbed sutures, both suture types showed comparable anatomic outcomes at 12 months, suggesting that the choice of suture may not impact long-term effectiveness in preventing pelvic organ prolapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of vaginal mesh attachment techniques for minimally invasive sacrocolpopexy. Tan-Kim, J., Nager, CW., Grimes, CL., et al.[2022]

In a study of 20 patients undergoing robotic sacrocolpopexy (RSC) with barbed delayed absorbable sutures, there were no recurrences of apical defects or mesh-related complications after 1 year, indicating the procedure's safety and efficacy.

While the majority of patients had successful outcomes, a few experienced complications, including a grade 2 cystocele and new-onset urinary incontinence, suggesting that while the technique is effective, further research is needed to assess long-term outcomes and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of robotic sacrocolpopexy using barbed delayed absorbable sutures. Borahay, MA., Oge, T., Walsh, TM., et al.[2022]

The V-Loc™ 180 Wound Closure Device demonstrated significantly greater biomechanical strength compared to the Quill™ PDO Knotless Tissue-Closure Device in a porcine model, particularly at critical healing timepoints (days 3 and 7).

Both devices showed no major complications or issues such as suture extrusion or tissue distortion, indicating that they are safe for use in skin closures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of V-Loc™ 180 wound closure device and Quill™ PDO knotless tissue-closure device for intradermal closure in a porcine in vivo model: evaluation of biomechanical wound strength. Gingras, K., Zaruby, J., Maul, D.[2020]

In a study of 57 subjects who underwent uterosacral ligament suspension (USLS) with delayed absorbable polyglyconate suture, only 3.5% experienced suture complications, indicating a high safety profile for this suture type.

The anatomic and symptomatic failure rate was low at 7%, significantly lower than the 44.6% suture erosion rate seen with permanent sutures in previous studies, suggesting that polyglyconate suture is an effective option for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterosacral ligament vaginal vault suspension using delayed absorbable monofilament suture. Wong, MJ., Rezvan, A., Bhatia, NN., et al.[2021]

In a study of 119 women undergoing robot-assisted sacral colpopexy, using delayed absorbable sutures for mesh fixation resulted in significantly fewer suture erosions compared to traditional nonabsorbable sutures, with only 2 erosions noted in the absorbable group versus 9 in the nonabsorbable group.

The use of delayed absorbable sutures did not increase the risk of surgical failure, as apical and posterior compartment failures were similar between the two suture types, suggesting that this alternative suture may improve postoperative outcomes without compromising effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Securing Mesh with Delayed Absorbable Suture Does Not Increase Risk of Prolapse Recurrence After Robotic Sacral Colpopexy. Powell, CR., Tachibana, I., Eckrich, B., et al.[2021]

In a study of 490 women undergoing total laparoscopic hysterectomy, the V-Loc barbed suture was associated with shorter operative times and less estimated blood loss compared to the Polysorb braided absorbable suture.

The V-Loc suture also resulted in fewer cases of vaginal cuff granulomatous formation six months post-surgery, indicating it may be a safer and more effective option for vaginal cuff closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

V-Loc™ 180 suture in total laparoscopic hysterectomy: a retrospective study comparing Polysorb to barbed suture used for vaginal cuff closure. Cong, L., Li, C., Wei, B., et al.[2022]

A review of 8 studies involving 726 subjects found that both autologous fascial slings (AFS) and synthetic slings (SS) are effective in treating female stress urinary incontinence (SUI), with similar success rates in both short- and long-term follow-ups.

While AFS has comparable effectiveness to SS, it requires longer operative times and hospital stays, and is associated with fewer complications like bladder perforation, making it a safer alternative as concerns about synthetic materials grow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resurgence of Autologous Fascial Slings in a Challenging Climate for Sling Surgery: A 20-Year Review of Comparative Data. Chen, YA., Jean-Michel, M.[2022]

A new surgical technique for treating female stress urinary incontinence involves placing two double monofilament sutures in a spiral pattern on the vaginal walls, which are then secured to Cooper's ligament.

In a preliminary study of 26 patients, this technique was found to be easy to perform and showed a wide range of applicability, suggesting it could be a promising option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new colpocystourethropexy for female stress urinary incontinence. Lenzi, R., Barbagli, G., Stomaci, N., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24263027/

Outcomes of robotic sacrocolpopexy using barbed delayed ... Our study suggests that barbed delayed absorbable sutures are safe and effective in RCS procedures over 1 year.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465013013691

Outcomes of Robotic Sacrocolpopexy Using Barbed ... The study included a total of 20 patients, of them 15 had grades 3 or 4 whereas 5 had grade 2 apical defects according to the Baden-Walker classification ...

3. journals.lww.com journals.lww.com/greenjournal/fulltext/2025/05001/best__barbed_suture_efficiency_study_for.48.aspx

BEST: Barbed-Suture Efficiency Study for Sacrocolpopexy The primary objective was to determine if unidirectional barbed suture results in a 50% faster vaginal mesh attachment compared to non-barbed suture for ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6821990/

Current surgical management of pelvic organ prolapse Another retrospective study reported 1-year outcomes in 20 patients who underwent RSC using barbed delayed absorbable sutures (3-0 V-Loc 180, Covidien, Dublin, ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1111/aogs.13997

Comparison of absorbable and permanent sutures for ... The reported success rate for LSC is 74%-98%, and LSC is associated with lower rates of recurrent prolapse (2.3%-4% vs 4.3%-18%) and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06024109

Performance of SYMMCORA® vs. V-Loc® Suture Material ... The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01608568

Affixing Polypropylene Mesh Using Barbed Suture (Quill™ ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...