Surgical Techniques for C-Section

Recruiting in Palo Alto (17 mi)

Overseen by Joshua F Nitsche, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Must not be taking: Steroids

Disqualifiers: Non-English, Incarcerated, Connective tissue, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using systemic steroids, you would not be eligible to participate.

What data supports the effectiveness of the treatment absorbable subcuticular polyglycolic acid staples (INSORB) for C-section?

Research shows that Insorb absorbable staples can reduce the time it takes to close surgical incisions without compromising healing quality, as seen in studies involving abdominal and breast surgeries. Additionally, poliglecaprone-25 sutures, similar to those used in C-sections, have been shown to effectively close wounds with a low risk of complications. ^{1 2 3 4 5}

Is the use of absorbable subcuticular staples and sutures safe for humans?

Research shows that absorbable subcuticular staples and sutures, like poliglecaprone 25 (Monocryl) and polyglycolic acid, are generally safe for use in humans. They cause minimal tissue reaction and are well-tolerated by the body, with low risk of inflammation at the site of use. ^{1 2 4 6 7}

What makes the treatment with absorbable subcuticular polyglycolic acid staples (INSORB) and polyglecaprone suture (Monocryl) unique for C-section closure?

This treatment is unique because it uses absorbable staples and sutures that reduce closure time without compromising healing quality, offering a quicker and potentially more comfortable recovery compared to traditional non-absorbable sutures that require removal. ^{1 2 3 5 6}

Research Team

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for individuals who have recently undergone a cesarean section (C-section) and are interested in the best method for wound closure to optimize healing and appearance. Specific eligibility criteria details were not provided.

Inclusion Criteria

Scheduled cesarean section

Any race

Any parity

Exclusion Criteria

Body Mass Index (BMI) >40

Non-English Speaking

Incarcerated

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

6 weeks

In-hospital stay

Follow-up

Participants are monitored for scar cosmesis, pain, satisfaction, and wound complications

6 weeks

Digital photography and assessments

Treatment Details

Interventions

• absorbable subcuticular polyglycolic acid staples (INSORB) (Procedure)
• subcuticular, polyglecaprone suture (Monocryl) (Procedure)

Trial Overview The study is comparing two types of wound closure techniques after C-section: stitches with polyglecaprone suture (Monocryl) versus absorbable staples made of polyglycolic acid (INSORB). The goal is to determine which provides better cosmetic outcomes.

Participant Groups

Group I: subcuticular absorbable polyglecaprone suture (Monocryl) Active Control 1 Intervention

Monocryl absorbable staples are used for skin closure

Group II: subcuticular absorbable polyglycolic acid (INSORB) staples Active Control 1 Intervention

Insorb absorbable staples are used for skin closure

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

Using Insorb absorbable staples for closing surgical incisions in procedures like mammaplasty and abdominoplasty significantly reduces closure time, being approximately 7 times faster than absorbable sutures.

Despite the faster closure time with staples, there were no significant differences in scar quality, pruritus, or pain between the two methods, indicating that staples are a safe and effective alternative for incision closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of Absorbable Dermal Staples in Mammaplasty and Abdominoplasty: A 12-Month Prospective Study of 60 Patients. Bron, T., Zakine, G.[2016]

A study involving 124 women undergoing cesarean delivery found that both Monoglyde® and Monocryl® poliglecaprone-25 sutures had similar outcomes regarding wound complications, such as surgical site infections and wound dehiscence, within the first 30 days postpartum.

The research demonstrated that there were no significant differences in secondary outcomes, including pain levels, suture handling, and patient satisfaction, indicating that both sutures are equally effective and safe for use in skin closure after cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Equivalence of Monoglyde® and Monocryl® Absorbable Poliglecaprone-25 Sutures: A Single-Blind, Randomized Study. Sailakshmi, M., Misra, S., Hs, S., et al.[2023]

In a study comparing two suture techniques on 100 skin incisions, the absorbable polyglycolic acid (Dexon) sutures resulted in less inflammation and no increase in hypertrophic scar formation compared to the standard polyamid (Supramid) interrupted sutures.

While Dexon sutures produced broader scars, they offered slightly better cosmetic results and eliminated the need for suture removal, making them a recommended option for skin closure in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyglycolic acid, Dexon subcuticular suture in paediatric orthopaedic surgery. Fasting, OJ., Bjerkreim, I.[2007]

In a laboratory study comparing the knotting abilities of various synthetic absorbable sutures, Monocryl (poliglecaprone 25) demonstrated similar mechanical performance to Vicryl but was less secure than Maxon and PDS-2 for certain knot types.

The results suggest that while Monocryl is effective, its knot security is not superior to some other sutures, indicating that factors like degradation rate should also be considered when choosing sutures for specific applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knotting abilities of a new absorbable monofilament suture: poliglecaprone 25 (Monocryl). Trimbos, JB., Niggebrugge, A., Trimbos, R., et al.[2008]

In a multicenter study involving 100 patients undergoing abdominal dermolipectomy or breast surgery, the use of absorbable staples (Insorb) significantly reduced closure time compared to traditional absorbable thread sutures.

Both methods resulted in similar healing quality after one year, indicating that Insorb staples are a safe and effective alternative for dermal closure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of skin closure time without loss of healing quality: a multicenter prospective study in 100 patients comparing the use of Insorb absorbable staples with absorbable thread for dermal suture. Duteille, F., Rouif, M., Alfandari, B., et al.[2013]

Polyglycolic acid, a new synthetic suture material, showed minimal signs of inflammation in experimental and clinical settings, indicating it is more inert and better tolerated by the body compared to traditional chronic catgut sutures.

The material was tested in both single-layer intestinal sutures and various general surgery operations, suggesting its versatility and potential for broader surgical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental and clinical studies on the use of a new suture material: polyglycolic acid]. Micali, G., Russo, A., Sanfilippo, G.[2011]

In a study involving 72 rats, three types of monofilament synthetic absorbable sutures were compared, revealing that Poliglecaprone 25 and Glycomer 631 caused less tissue reaction than Polydioxanone, making them preferable for minimizing inflammation.

All three suture materials were found suitable for intracuticular use, with absorption times varying: Poliglecaprone 25 absorbed in less than 3 months, Glycomer 631 in 3 to 6 months, and Polydioxanone in about 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study on biocompatibility and absorption times of three absorbable monofilament suture materials (Polydioxanone, Poliglecaprone 25, Glycomer 631). Molea, G., Schonauer, F., Bifulco, G., et al.[2012]

References

1. England pubmed.ncbi.nlm.nih.gov

Placement of Absorbable Dermal Staples in Mammaplasty and Abdominoplasty: A 12-Month Prospective Study of 60 Patients. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Equivalence of Monoglyde® and Monocryl® Absorbable Poliglecaprone-25 Sutures: A Single-Blind, Randomized Study. [2023]

3. Sweden pubmed.ncbi.nlm.nih.gov

Polyglycolic acid, Dexon subcuticular suture in paediatric orthopaedic surgery. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Knotting abilities of a new absorbable monofilament suture: poliglecaprone 25 (Monocryl). [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Reduction of skin closure time without loss of healing quality: a multicenter prospective study in 100 patients comparing the use of Insorb absorbable staples with absorbable thread for dermal suture. [2013]

6. Italy pubmed.ncbi.nlm.nih.gov

[Experimental and clinical studies on the use of a new suture material: polyglycolic acid]. [2011]

7. England pubmed.ncbi.nlm.nih.gov

Comparative study on biocompatibility and absorption times of three absorbable monofilament suture materials (Polydioxanone, Poliglecaprone 25, Glycomer 631). [2012]