Suture Techniques for Surgical Wounds

Not currently recruiting at 2 trial locations

Overseen By Eric Wagner, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnant, Prisoners, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best suture methods for closing incisions after upper extremity surgeries, such as those on the hand or shoulder. By comparing different types of sutures and techniques, including Gut sutures (also known as Catgut or Chromic catgut sutures) and Monocryl sutures (Poliglecaprone 25), researchers hope to determine which ones result in less pain and better healing after surgery. The study includes individuals scheduled for surgeries on their fingers, hands, wrists, elbows, or shoulders. Surgeons at Emory will identify participants and inform them about the study before their surgery. As an unphased trial, this study allows participants to contribute to improving surgical outcomes for future patients.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the research team or your doctor.

What prior data suggests that these suture techniques are safe for surgical wound closure?

Research shows that Monocryl stitches often close surgical cuts. They dissolve over time and are easy to handle. However, studies have found that using Monocryl in some surgeries can increase the risk of the wound reopening within 90 days after the operation.

In contrast, Nylon stitches do not dissolve and are commonly used to close skin. The FDA has approved them. One downside is that they can be difficult to tie securely, which might affect healing if not done properly.

Both Monocryl and Nylon have been used for a long time, and evidence suggests they are generally safe. However, like any medical treatment, some risks exist. It's always advisable to consult a healthcare provider to determine the best option for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different suture techniques and materials for closing surgical wounds, which could lead to improved healing and cosmetic outcomes. Standard suture methods often use non-absorbable materials like Nylon or absorbable ones like Gut and Monocryl, but this study examines variations in how these materials are applied, such as whether the sutures are buried or not and if the stitching is interrupted or running. By comparing these methods, researchers hope to identify which techniques provide the best balance of strength, speed of healing, and minimal scarring. This could ultimately lead to better patient experiences and outcomes after surgery.

What evidence suggests that this trial's suture techniques could be effective for surgical wound closure?

This trial will compare different suture techniques for surgical wounds. Research has shown that Monocryl stitches, one of the techniques tested in this trial, can lead to better early results for carpal tunnel surgeries, with higher satisfaction from both patients and doctors. However, the wound may reopen within 90 days more frequently. Monocryl loses strength faster than some other stitches, which might affect its longevity.

For Nylon stitches, another technique under study in this trial, studies indicate they work as well as dissolvable stitches in preventing infections and scars. They are considered a dependable choice for closing surgical wounds without causing additional problems. Both Monocryl and Nylon offer benefits, so the choice may depend on the specific needs of the surgery and the patient. ^{1 2 3 6 7}

Who Is on the Research Team?

Eric Wagner, MD, MS

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 99 with upper extremity injuries (from fingers to shoulders) who need surgery and can consent. It's not for those unable to consent, under 18, pregnant women, or prisoners.

Inclusion Criteria

I am having surgery for an injury to my arm or hand.

Exclusion Criteria

I am unable to give consent for myself.

Prisoners

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo upper extremity surgical procedures with randomized suture types and techniques

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain and wound healing through questionnaires and surgeon assessments

12 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Gut not buried interrupted
• Monocryl buried interrupted
• Monocryl buried running
• Monocryl not buried interrupted
• Monocryl not buried running
• Nylon not buried interrupted
• Nylon not buried running

Trial Overview The study compares two suture types and techniques: Gut sutures using a non-buried interrupted method versus Monocryl sutures with a buried interrupted technique. The goal is to see which one results in less postoperative pain and better wound healing.

How Is the Trial Designed?

Group I: Monocryl buried Active Control 1 Intervention

Upper extremity primary surgical wound closure via suture with Monocryl buried

Group II: Nylon (FDA Approved) not buried Active Control 1 Intervention

Upper extremity primary surgical wound closure via suture with Nylon(FDA Approved) not buried

Gut not buried interrupted is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Gut suture for:

• General soft tissue approximation and/or ligation
• Orthopedic procedures
• Skin closure

Approved in European Union as Catgut suture for:

• General soft tissue approximation and/or ligation
• Orthopedic procedures
• Skin closure

Approved in Canada as Chromic catgut suture for:

• General soft tissue approximation and/or ligation
• Orthopedic procedures
• Skin closure

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

The study found that the bioaccumulation of surfactants like 4-nonylphenol (4-NP) and linear alkylbenzene sulfonates (LAS) in the oligochaete worm Lumbriculus variegatus increased as the organic carbon content of sediments decreased, indicating that lower organic matter leads to higher chemical bioavailability.

Acute toxicity tests revealed that Lumbriculus variegatus tolerated higher tissue residues of both chemicals compared to Chironomus riparius larvae, which experienced sublethal effects on growth, suggesting that body residue measurements are a more reliable indicator of chemical exposure than environmental concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioaccumulation and toxicity of 4-nonylphenol (4-NP) and 4-(2-dodecyl)-benzene sulfonate (LAS) in Lumbriculus variegatus (Oligochaeta) and Chironomus riparius (Insecta). Mäenpää, K., Kukkonen, JV.[2016]

The study found that antifouling paint biocides, particularly Irgarol 1051 and diuron, persist in aquatic environments due to their low tendency to attach to sediments and high resistance to degradation, posing potential long-term environmental risks.

High-pressure hosing of painted hulls was identified as a significant source of biocide input into water bodies, raising concerns about the environmental impact of these substances, especially since they are often released in the form of paint particles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antifouling paint booster biocides in UK coastal waters: inputs, occurrence and environmental fate. Thomas, KV., McHugh, M., Waldock, M.[2019]

A new method was developed that allows the oligochaete Lumbriculus variegatus to self-extract from detrital material, achieving about 90% recovery of the worms at the end of sediment bioaccumulation tests.

The tissue residue analysis showed that the polychlorinated biphenyl levels in the self-extracted worms were comparable to those recovered through traditional manual separation, indicating that this new method is effective and reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Streamlining Freshwater Bioaccumulation Bioassays: Letting the Worms Do the Hard Work. Lotufo, GR., Melby, NL., Biedenbach, JM., et al.[2022]

The study evaluated the bioavailability of four contaminants in sediment samples from three European river basins, finding that the polyoxymethylene passive sampling method is more effective than Tenax extraction for predicting the bioavailability of hydrophobic compounds.

Freely dissolved concentrations in pore water were found to be the main factor influencing the uptake of these contaminants by organisms, suggesting that while sediment characteristics had minor effects, further bioassays are necessary to validate passive sampling methods in risk assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting the bioavailability of sediment-associated spiked compounds by using the polyoxymethylene passive sampling and tenax extraction methods in sediments from three river basins in Europe. Sormunen, AJ., Tuikka, AI., Akkanen, J., et al.[2013]

A new multiresidue method using isotope dilution and LC-ESI-MS/MS was developed to effectively identify and quantify 26 pesticides in sediment, demonstrating high sensitivity and accuracy with limits of detection in the low ng/g range.

The method successfully analyzed real sediment samples from Spanish rivers, detecting five pesticides, including chlorpyrifos, diuron, and diazinon, which are known for their bioaccumulation and low mobility, highlighting the method's practical application in environmental monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a multiresidue method for analysis of pesticides in sediments based on isotope dilution and liquid chromatography-electrospray-tandem mass spectrometry. Köck-Schulmeyer, M., Olmos, M., López de Alda, M., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325003729

Increased wound complications in glabrous skin with ... We found usage of Monocryl sutures following carpal tunnel and trigger finger release associated with higher a dehiscence rate within 90 days post-operation.

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/17531934231178383

and observer-assessed outcomes following carpal tunnel ... Monocryl suture represents an effective method for carpal tunnel closure that leads to improved patient- and observer-reported outcome scores in the early ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK569837/

Evidence review for the effectiveness of closure materials and ... The aim of this review is to identify closure material and techniques that may reduce the risk of surgical site infection.

4. academic.oup.com academic.oup.com/asj/article/39/Supplement_2/S85/5377469

Deep and Superficial Closure | Aesthetic Surgery Journal This paper reviews methods available to perform incisional closure and the published clinical data regarding their use.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/vsu.14224

Impact of suture materials polydioxanone and ... When comparing published tensile strength data, Monocryl weakens faster than Vicryl. The tensile strength of Monocryl is 50% at 1–2 weeks ...

6. sciencedirect.com sciencedirect.com/topics/nursing-and-health-professions/poliglecaprone

Poliglecaprone - an overview Even though Monocryl is an absorbable suture, it has been recommended for superficial skin closure of surgical incisions in numerous anatomic sites such as face ...

7. jnjmedtech.com jnjmedtech.com/en-US/product/monocryl-poliglecaprone-25-suture

MONOCRYL™ (poliglecaprone 25) Suture | Ethicon MONOCRYL Suture is a highly pliable monofilament suture that handles and ties easily, is virtually inert in tissue, and absorbs predictably.