Suture Techniques for Surgical Wounds

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

160 Participants Needed

Trial Summary

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 makes the suture techniques for surgical wounds unique compared to other treatments?

The suture techniques in this trial are unique because they explore different methods of using sutures, such as buried versus not buried and interrupted versus running, with various materials like Monocryl and Nylon. This approach aims to optimize wound healing by comparing the effectiveness and outcomes of these different suture techniques. ^{1 2 3 4 5}

What is the purpose of this trial?

Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques. This study specifically would focus on comparing different suture types and techniques and their efficacy. This will be a randomized controlled trial comparing currently used, standard of care suture types and currently used, standard of care suture techniques to identify differences, if any exist, in postoperative pain scores and wound healing as assessed by exam and postoperative patient surveys. Patients will be identified by the Emory Upper Extremity/Hand Surgeons as they are identified as a candidate for surgery. Participants will then be informed of the study and spoken to about the specifics of the study. The research team will consent and recruit patients either in The Emory Clinic or in the preoperative area prior to surgery. All surgical operations will take place at the ambulatory surgical center in The Emory Clinic or at the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participation in this study. No specimens/data/samples will be collected and stored for later use, and there are no optional substudies. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature.

Research Team

Eric Wagner, MD, MS

Principal Investigator

Emory University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Antifouling paint booster biocides in UK coastal waters: inputs, occurrence and environmental fate. [2019]

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

Streamlining Freshwater Bioaccumulation Bioassays: Letting the Worms Do the Hard Work. [2022]

3. United States 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. [2013]

4. Netherlands 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). [2016]

5. Netherlands 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. [2019]