Absorbable Staples for Cesarean Delivery

Overseen By Michelle L Cassidy, PhD, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Inova Health Care Services

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunosuppression, Skin infection, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 8 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether absorbable staples can speed up cesarean surgeries and improve scar appearance. Participants will have their cesarean incisions closed with either the new staples (subcuticular absorbable staple using the Insorb device) or traditional sutures (subcuticular monocryl suture). Women who are at least 24 weeks pregnant and planning a cesarean are suitable candidates for this study. The goal is to determine if these staples provide better results than the usual stitches used in surgery. As an unphased trial, this study allows participants to contribute to innovative surgical advancements.

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

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

What prior data suggests that these wound closure techniques are safe for cesarean delivery?

Research has shown that subcuticular absorbable staples, such as those from the Insorb device, provide a safe method for closing the skin after a cesarean delivery. Studies have found that these staples can reduce common post-surgery issues, including infections at the surgery site, wound separation, and patient discomfort.

The time required for surgery using these staples appears similar to that with traditional stitches. However, some studies suggest that staples might lead to more wound complications than stitches.

Both staples and stitches have been used in surgeries extensively, providing a wealth of safety information. For more questions about the safety of these treatments, it is advisable to consult the clinical trial team, who can offer detailed information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using absorbable staples for cesarean delivery because they offer a novel approach to wound closure compared to traditional sutures or metal staples. The Insorb device uses subcuticular absorbable staples, which are placed under the skin and naturally dissolve over time, potentially reducing the need for follow-up visits to remove staples and minimizing scarring. This method also aims to decrease the risk of infection and improve patient comfort and recovery time. By providing a more seamless and less intrusive healing process, absorbable staples could become a preferred option for cesarean delivery closures.

What evidence suggests that this trial's treatments could be effective for cesarean delivery?

Research has shown that INSORB staples, which are absorbable and placed under the skin, can be quicker and more cost-effective than traditional stitches for C-section deliveries. In this trial, participants will be assigned to either the absorbable staple wound closure arm or the suture wound closure arm. Studies have found that these staples can shorten surgery time and hospital stays without increasing the need for pain medication. They also seem to reduce the risk of wound problems like infections and wound separation. Patients might also be more satisfied due to better-looking scars. Overall, INSORB staples offer promising results for those considering C-section delivery options. ^{2 3 6 7 8}

Who Is on the Research Team?

Antonio Saad, MD

Principal Investigator

Inova Fairfax Medical Center

Are You a Good Fit for This Trial?

This trial is for women undergoing cesarean delivery. Specific eligibility criteria are not provided, so it's assumed that participants should be in good health and have no conditions that would interfere with wound healing or the use of sutures or staples.

Inclusion Criteria

I am at least 24 weeks pregnant.

Will be undergoing cesarean delivery

I am between 18 and 50 years old.

Exclusion Criteria

I am unable or unwilling to give my consent for participation.

No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery

Incarcerated individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cesarean delivery with either absorbable staples or sutures for skin closure

Up to 8 hours

1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for wound cosmesis, post-operative pain, and adverse events

6 weeks

2 visits (in-person, at POD 5-10 days and 4-6 weeks post-partum)

What Are the Treatments Tested in This Trial?

Interventions

• Subcuticular absorbable staple using Insorb device
• Subcuticular monocryl suture

Trial Overview The study is testing if using subcuticular absorbable staples can improve operative time and wound appearance after a cesarean compared to conventional skin closure with monocryl suture.

How Is the Trial Designed?

Group I: Absorbable staple wound closure Experimental Treatment 1 Intervention

Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical.

Group II: Suture wound closure Active Control 1 Intervention

Absorbable Moncryl sutures for closure of cesarean skin incision

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Citations

1. journals.lww.com journals.lww.com/greenjournal/abstract/2015/05001/absorbable_subcuticular_staples_compared_with.85.aspx

Absorbable Subcuticular Staples Compared With Suture for... CONCLUSION: For cesarean delivery, the INSORB staple is faster and more cost-effective than subcuticular suture and has equivalent analgesic use ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12176926/

Comparison of complications and surgery outcomes in skin ... This study demonstrates that absorbable subcutaneous staples as a skin closure method for cesarean delivery significantly reduce surgery time, hospitalization ...

3. insorb.com insorb.com/wp-content/uploads/500-Consecutive-Cesarean-Deliveries-Closed-With-Subcuticular-Absorbable-Staples.pdf

500-Consecutive-Cesarean-Deliveries-Closed-With- ... Subcuticular staples may offer improvements in clinical outcomes, patient satisfaction, efficiencies and cost savings. The study of 500 consecutive cesarean ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01753518

NCT01753518 | A Clinical Trial of Subcuticular Staples ... The purpose of this study is to determine if the new absorbable subcuticular staples (INSORB) improves outcomes compared to the current standard absorbable ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301211516308284

Incidence of wound complications in cesarean deliveries ... INSORB's subcuticular stapling system reduces postoperative complications such as: i) surgical site infection, ii) wound separation, iii) patient discomfort, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30461155/

Absorbable subcuticular staples versus suture for ... For caesarean section skin closure, absorbable subcuticular staples did not result in significantly different total operative times compared with sutures.

7. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/abs/10.1111/1471-0528.15532

Absorbable subcuticular staples versus suture for caesarean ... Primary outcomes were total operating time, from incision start to close. Secondary outcomes included subcuticular skin closure time, patient ...

8. ajog.org ajog.org/article/S0002-9378(11)01957-0/fulltext

649: Randomized trial of surgical staples vs subcuticular ... Conclusion. Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean section.