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

Trial Summary

What is the purpose of this trial?

This pilot study is designed to assess the feasibility of comparing skin closure methods - sutures versus staples - and subsequent rates of surgical site infection following open reduction and internal fixation surgery for orthopaedic trauma injuries. The primary objectives are to determine if enrollment, randomization, and compliance are feasible and to refine data collection methods. Patients =18 years of age with closed fractures of the tibial plateau, tibial pilon, patella, and distal femur presenting within 3 weeks of injury undergoing definitive treatment of their fracture will be approached for participation. If enrolled, they will be randomized to having their surgical wound closed with either nylon sutures or metallic staples. Patient follow up will be standard of care besides answering PROMIS surveys.

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 data supports the effectiveness of the treatment Sutures vs Staples for Lower Extremity Fractures?

Research shows that staples can significantly reduce the time needed for wound closure compared to sutures, which can be beneficial in surgeries. However, there is a higher risk of infection with staples in some orthopedic procedures, so the choice of material may depend on specific patient factors and surgical context. ^{1 2 3 4 5}

Are sutures and staples safe for wound closure in surgeries?

Both sutures and staples are generally safe for wound closure in surgeries, but there are some differences. Staples are faster to apply and less painful, but they may have a higher risk of infection in some cases. Sutures, especially non-absorbable ones, can sometimes cause discomfort, but they are a good alternative to metal wires in certain surgeries. ^{1 3 5 6 7}

What makes the treatment of sutures vs staples for lower extremity fractures unique?

The treatment of using sutures versus staples for lower extremity fractures is unique because it directly compares two common methods of closing surgical wounds, focusing on their effectiveness and potential benefits in healing and recovery. This approach is novel as it evaluates the specific outcomes of using metallic staples versus various types of sutures (nylon, absorbable, and non-absorbable) in a specific type of fracture, which can help determine the best method for wound closure in these cases. ^{8 9 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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?

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

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

Foot and Ankle Surgical Incision Closure With Three Different Materials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Staples versus sutures wound closure in hip and knee arthroplasty: a prospective cohort study. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Nylon sutures versus skin staples in foot and ankle surgery: is there a clinical difference? [2021]

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

Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The use of non-absorbable suture in the fixation of patellar fractures: a preliminary report. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

A bio-based macromolecular phosphorus-containing active cotton flame retardant synthesized from starch. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Terminal group effects of DOPO-conjugated flame retardant on polyamide 6: Thermal stability, flame retardancy and mechanical performances. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Graphene oxide functionalized biomolecules for improved flame retardancy of Polyamide 66 fabrics with intact physical properties. [2021]

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

Delamination and Engineered Interlayers of Ti3C2 MXenes using Phosphorous Vapor toward Flame-Retardant Epoxy Nanocomposites. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Chitosan-based flame retardant coatings for polyamide 66 textiles: One-pot deposition versus layer-by-layer assembly. [2020]