Surgical Techniques for C-Section

Overseen By Christina Tulbert

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Steroids

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for closing the skin after a cesarean section (C-section) to determine which might be superior. The methods tested are absorbable subcuticular polyglycolic acid staples (INSORB) and a special type of suture called subcuticular, polyglecaprone suture (Monocryl). Women scheduled for a C-section and receiving neuraxial analgesia (a type of pain relief given around the spine) might be suitable for this trial. The goal is to identify which method offers the best healing and recovery outcomes. As an unphased trial, this study allows participants to contribute to valuable research that could enhance surgical outcomes for future patients.

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 prior data suggests that these surgical techniques are safe for C-section deliveries?

Research has shown that absorbable staples called INSORB, used under the skin, can reduce the need for pain relief after C-sections, indicating good tolerance. One study found that these staples do not increase surgery time compared to traditional stitches, reassuring for safety.

For Monocryl stitches, studies indicate they are safe and linked to fewer infections. They dissolve on their own, eliminating the need for removal, which can ease recovery. Overall, both treatments appear to be safe options for closing the skin after a C-section. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for C-section skin closure because they explore innovative ways to improve healing and patient comfort. Unlike traditional methods using non-absorbable sutures or metal staples, INSORB staples and Monocryl sutures are absorbable, which means they don't need to be removed and can reduce visits to the doctor. This could lead to less scarring and potentially a lower risk of infection. The INSORB staples use a unique material, polyglycolic acid, while Monocryl sutures use polyglecaprone, both designed to be gentle on the skin. These advancements could significantly enhance recovery experiences for new mothers.

What evidence suggests that these surgical techniques for C-section could be effective?

This trial will compare two methods for closing the skin after a C-section: absorbable staples (INSORB) and absorbable stitches (Monocryl). Studies have shown that absorbable staples are generally safe and might enhance patient satisfaction and recovery. In a study of 500 C-sections, these staples proved more efficient and cost-effective. Evidence indicates that absorbable stitches reduce infection rates compared to non-absorbable stitches and may result in better-looking scars. Both methods aim to safely and effectively close the skin after a C-section, providing good options for mothers. ^{1 2 4 6 7}

Who Is on the Research Team?

Joshua F Nitsche, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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

Non-English Speaking

Body Mass Index (BMI) >40

Incarcerated

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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

absorbable subcuticular polyglycolic acid staples (INSORB) is already approved in United States, European Union for the following indications:

Approved in United States as INSORB for:

• Post-operative cesarean section cosmesis
• General soft tissue approximation

Approved in European Union as INSORB for:

• Soft tissue approximation
• Post-operative wound closure

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

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 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]

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]

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]

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 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]

Citations

1. 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.

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6988900/

Techniques and materials for skin closure in caesarean section The two methods of skin closure for caesarean that have been most often compared are non‐absorbable staples and absorbable subcutaneous sutures.

4. journals.plos.org journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0270337&type=printable

Comparison of the effect of skin closure materials on skin ... In conclusion, our network meta-analysis showed that the risk of skin separation with absorbable suture after cesarean delivery was reduced ...

5. withpower.com withpower.com/trial/surgical-techniques-for-c-section-86188

Surgical Techniques for C-Section Research shows that absorbable subcuticular staples and sutures, like poliglecaprone 25 (Monocryl) and polyglycolic acid, are generally safe for use in humans.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06412978

NCT06412978 | Post-Operative Cesarean Section Cosmesis Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study ...

7. ovid.com ovid.com/journals/bjogy/pdf/10.1111/1471-0528.15532~absorbable-subcuticular-staples-versus-suture-for-caesarean

Absorbable subcuticular staples versus suture for ... Secondary outcomes included subcuticular skin closure time, patient and surgeon satisfaction, percutaneous injuries, pain (analgesic use), ...