Sutures vs Staples for Lower Extremity Fractures

(SvS Trial)

Overseen By Pui Yan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Open fractures, Incarcerated, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to close surgical wounds after certain leg fractures by comparing two methods: stitches (sutures) and metal clips (staples) to determine which reduces infection risk. The trial seeks to enroll and follow up with individuals who have recent closed leg fractures, such as those of the knee or lower thigh. Patients who speak English or Spanish and have experienced leg fractures may be suitable candidates. Participants will have their wounds closed using one of the methods and will continue with standard care. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance surgical care for future patients.

Will I have to stop taking my current medications?

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

What prior data suggests that these skin closure methods are safe for surgical wound closure?

Research has shown that using staples to close the skin after surgeries, such as those for ankle fractures, is generally safe. Staples are dependable and usually close wounds effectively. However, some studies have noted that staples might cause more fluid to leak from the wound. One advantage of staples is their quicker application and less painful removal.

Conversely, studies indicate that stitches (sutures) also work well for closing the skin. There is no significant difference in infection rates between different types of stitches. Both dissolving and permanent stitches are similarly effective in preventing infections and other complications.

In summary, both staples and stitches are safe options for closing surgical wounds. Each has its own advantages and minor downsides, but neither is significantly superior in terms of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing sutures and staples for closing wounds in lower extremity fractures because each method offers distinct benefits and potential improvements in patient care. Sutures, traditionally used, provide precise closure and are less likely to cause infection, but they can be time-consuming to apply. Staples, on the other hand, are quicker to apply and may reduce surgery time, potentially lowering the risk of complications. By directly comparing these two methods, researchers hope to determine which one offers better healing outcomes, less pain, or fewer complications, ultimately enhancing recovery for patients with lower extremity fractures.

What evidence suggests that this trial's treatments could be effective for lower extremity fractures?

This trial will compare sutures and staples for wound closure in lower extremity fractures. Studies have shown that stitches generally lead to fewer infections than staples in bone surgeries. Research indicates that staples might cause more fluid leakage from the wound and could extend hospital stays. However, staples are quicker to insert and remove, and some patients find them less painful. Stitches, particularly those that dissolve, can reduce the need for follow-up visits since they don't require removal. Overall, while both methods are effective, stitches seem to slightly lower the risk of infection. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with closed fractures in specific lower leg bones (tibial plateau, tibial pilon, patella, distal femur) who are within three weeks of injury and undergoing surgery. Participants will be chosen randomly to have their surgical wounds closed either with sutures or staples.

Inclusion Criteria

My surgical cuts can be closed with stitches under the skin.

I have a fracture in my lower leg, knee cap, or near my knee.

Exclusion Criteria

Pregnant patients

I have a broken bone that is exposed through my skin.

I have a skin condition like psoriasis or eczema.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical wound closure with either nylon sutures or metallic staples

Immediate post-surgery

Follow-up

Participants are monitored for surgical site infection and complete PROMIS surveys

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Staple
• Suture

Trial Overview The study aims to compare the effectiveness of sutures versus staples in preventing infections after orthopaedic trauma surgeries. It's a pilot study focusing on feasibility: can they enroll enough people, assign them randomly to treatments, and get reliable data from follow-ups?

How Is the Trial Designed?

Group I: Suture Experimental Treatment 1 Intervention

Wound Closure

Group II: Staple Experimental Treatment 1 Intervention

Wound Closure

Staple is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Approved in United States as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Approved in Canada as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Approved in Japan as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Approved in China as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Approved in Switzerland as Surgical Staples for:

• General surgical procedures
• Orthopaedic surgery

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

A proposed large randomized controlled trial will compare the rates of wound complications between sutures and staples in orthopedic surgeries, addressing concerns raised by previous studies that suggested a higher infection risk with staples.

The trial will use a comprehensive approach to measure all types of wound complications, ensuring that the results can provide clear guidance for orthopedic surgeons on the safest wound closure materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial. Shantz, JA., Vernon, J., Leiter, J., et al.[2022]

In a study of 61 patients undergoing foot and ankle surgeries, staple sutures significantly reduced surgical time compared to nylon sutures, indicating a more efficient wound closure method.

Patients who received staple closures reported less pain at the time of stitch removal and at the 6-week follow-up, suggesting higher patient satisfaction with staple sutures over nylon sutures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nylon sutures versus skin staples in foot and ankle surgery: is there a clinical difference? Daniilidis, K., Stukenborg-Colsman, C., Ettinger, S., et al.[2021]

A new method for creating Ti3C2 MXene using gas-assisted exfoliation with phosphorous vapor has been developed, allowing for the direct formation of a safe RP/Ti3C2 nanocomposite.

This nanocomposite shows promise as a flame retardant for epoxide resin, effectively reducing fire risks, highlighting its potential for practical applications in safety-related fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delamination and Engineered Interlayers of Ti3C2 MXenes using Phosphorous Vapor toward Flame-Retardant Epoxy Nanocomposites. Yuan, Y., Pan, YT., Zhang, W., et al.[2021]

The layer by layer (LbL) assembly method for applying flame retardant coatings on polyamide 66 (PA66) fabric resulted in a more uniform coating and significantly improved flame resistance, as indicated by a 23% increase in limiting oxygen index (LOI) and a 25% reduction in peak heat release rate (pHRR).

Only the LbL assembled and thermally cross-linked fabric maintained its flame retardant properties after undergoing 5 washing cycles, demonstrating its durability and effectiveness for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chitosan-based flame retardant coatings for polyamide 66 textiles: One-pot deposition versus layer-by-layer assembly. Kundu, CK., Wang, X., Song, L., et al.[2020]

In a study involving seven patients with patellar fractures, the use of a non-absorbable braided polyester suture (Ti-Cron) successfully fixed the fractures, leading to complete healing and good knee function restoration.

The polyester suture was easier to use than stainless steel wire, resulting in shorter surgery times and fewer complications, with only two patients needing suture removal, which was manageable in an outpatient setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of non-absorbable suture in the fixation of patellar fractures: a preliminary report. Chatakondu, SC., Abhaykumar, S., Elliott, DS.[2022]

In a study involving 200 patients with scalp wounds, metal staples were found to be significantly faster and less painful for wound closure compared to nylon sutures, with no difference in infection rates or overall morbidity.

Using staples also reduces the risk of accidental needle-stick injuries, making it a safer option for healthcare providers compared to traditional suturing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staples versus sutures in the closure of scalp wounds: a prospective, double-blind, randomized trial. Ritchie, AJ., Rocke, LG.[2019]

The novel flame retardant ammonium starch phosphate (ASTP) significantly improved the flame resistance of cotton fabrics, achieving a limiting oxygen index (LOI) of 45.2%, which indicates high flame retardancy.

ASTP-treated cotton fabrics maintained a LOI of 32.1% even after 50 laundry cycles, demonstrating excellent wash durability and suggesting that starch can effectively replace traditional polyhydric alcohols in creating durable, formaldehyde-free flame retardants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bio-based macromolecular phosphorus-containing active cotton flame retardant synthesized from starch. Lu, Y., Zhao, P., Chen, Y., et al.[2022]

The combination of lignin and phytic acid functionalized with graphene oxide significantly improved the flame retardant properties of polyamide 66 fabrics, achieving a 27% increase in limiting oxygen index (LOI) without compromising physical properties like color and strength.

The treated fabrics also showed a 25% reduction in peak heat release rate (pHRR) and maintained a 17% reduction in pHRR after 5 wash cycles, demonstrating both effectiveness and durability of the flame retardant treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graphene oxide functionalized biomolecules for improved flame retardancy of Polyamide 66 fabrics with intact physical properties. Kundu, CK., Li, Z., Li, X., et al.[2021]

In a meta-analysis of 6 studies involving 683 wounds, it was found that closing wounds with staples after orthopedic surgery significantly increased the risk of superficial wound infections compared to sutures, with a relative risk of 3.83.

Specifically for hip surgery, the risk of infection was even higher, at four times greater for staple closure than for sutures, suggesting that staples should be reconsidered for wound closure in orthopedic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. Smith, TO., Sexton, D., Mann, C., et al.[2022]

The DOPO-NH2 flame retardant significantly enhances the thermal, flame retardant, and mechanical properties of polyamide 6 (PA6) composites, outperforming the DIDOPO variant.

At a loading of 15 wt%, DOPO-NH2 improves the flame resistance of PA6, achieving a higher Limiting Oxygen Index (LOI) of 28.0% compared to 25.0% for DIDOPO, and demonstrates better compatibility with PA6 due to its amino-terminal group, which interacts effectively with the PA6 matrix.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Terminal group effects of DOPO-conjugated flame retardant on polyamide 6: Thermal stability, flame retardancy and mechanical performances. Gao, J., He, W., Xiang, Y., et al.[2022]

In a study of 124 patients undergoing foot and ankle surgery, no significant differences were found in clinical outcomes among absorbable sutures, nonabsorbable sutures, and metallic staples, indicating that all three materials are viable options for wound closure.

However, patients with nonabsorbable sutures reported significantly more pain at 6 weeks post-surgery, suggesting that while all materials are effective, absorbable sutures and staples may be preferable for minimizing discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foot and Ankle Surgical Incision Closure With Three Different Materials. Yao, D., Nachtsheim, J., Ettinger, S., et al.[2022]

In a study of 100 patients undergoing total hip and knee replacements, there was no significant difference in wound complications between those closed with staples and those closed with vertical mattress nylon sutures.

Both methods of wound closure resulted in similar levels of patient and nurse satisfaction, suggesting that the choice of closure technique can be based on available resources rather than efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staples versus sutures wound closure in hip and knee arthroplasty: a prospective cohort study. Al-Ajlouni, JM., Alisi, MS., Hammad, YS., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3495200/

Sutures versus staples for wound closure in orthopaedic surgery It is hypothesized that wounds closed with sutures and staples will have similar all-cause complication rates. The alternative hypothesis is that these wound ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958259218300658

Staple versus suture closure for ankle fracture fixation Staple closure is relatively as safe as suture closure with known advantage of reduced closure time, less painful removal and improved cosmetic appearance.

3. bmj.com bmj.com/content/340/bmj.c1199

Sutures versus staples for skin closure in orthopaedic surgery Six outcomes could be assessed with meta-analysis. The risk of a wound infection was over three times greater with staples than with sutures (P= ...

4. mdpi.com mdpi.com/2673-4095/6/3/72

Surgical Site Infection Rate in Sutured Versus Stapled ... Although the SSI type did not differ significantly between closure methods, wounds closed with staples showed increased wound discharge. LOS was notably longer ...

5. withpower.com withpower.com/trial/phase-lower-extremity-fractures-7-2024-1eff6

Sutures vs Staples for Lower Extremity Fractures (SvS Trial) In a study of 124 patients undergoing foot and ankle surgery, no significant differences were found in clinical outcomes among absorbable sutures, nonabsorbable ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32951119/

Skin closure with surgical staples in ankle fractures: a safe ... The current study supports that metal staples are a safe and reliable option in the closure of traumatic ankle fractures.

7. researchgate.net researchgate.net/profile/Case-Martin/publication/344331923_Skin_closure_with_surgical_staples_in_ankle_fractures_a_safe_and_reliable_method/links/5f837970299bf1b53e20bde2/Skin-closure-with-surgical-staples-in-ankle-fractures-a-safe-and-reliable-method.pdf?origin=scientificContributions

Skin closure with surgical staples in ankle fractures The current study supports that metal staples are a safe and reliable option in the closure of traumatic ankle fractures. Meticulous wound closure in ...