Wound Closure Techniques for Spinal Injury

Overseen By Cassandra Willson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: Pregnancy, Diabetes, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

Trial Summary

What is the purpose of this trial?

The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or long-term anticoagulation treatment, you cannot participate in the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on systemic corticosteroids or long-term anticoagulation treatment, you cannot participate.

What data supports the idea that Wound Closure Techniques for Spinal Injury is an effective treatment?

The available research shows that wound closure techniques, like vacuum-assisted closure (VAC), are effective in managing wound infections after spinal surgery. For example, one study found that using VAC helped treat early postoperative spinal wound infections, which can prevent the need to remove internal devices and avoid further spinal instability. Another study reviewed 12 cases and highlighted the growing popularity of VAC in managing deep infections after spinal surgery, suggesting it may be more effective than other treatments that have mixed results. Additionally, using specialized closure techniques in pediatric spinal surgeries has been shown to reduce wound complications, indicating their effectiveness in preventing issues after surgery. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Closure technique, Wound Closure Techniques, Suturing Techniques, Stapling, Adhesives for spinal injury?

The research suggests that using specific wound closure techniques, like those involving interdisciplinary care by spinal and plastic surgeons, can help reduce wound complications after spinal surgeries, as seen in pediatric spinal deformity cases. ^{1 2 3 4 5}

What safety data exists for wound closure techniques in spinal injury treatment?

The safety data for wound closure techniques, including sutures, staples, and adhesives, indicates that these methods are generally effective and safe. Studies have shown that cyanoacrylate skin adhesives, such as N-butyl-2-cyanoacrylate and octyl-cyanoacrylate, are effective for wound closure in surgeries, including spinal procedures, without increasing the risk of complications. These adhesives offer advantages like short application time and hemostatic properties. Additionally, newer techniques like zipper devices and novel adhesives are being explored for their potential to reduce complications and operative time compared to traditional sutures and staples. ^{6 7 8 9 10}

Is wound closure using adhesives and other techniques generally safe for humans?

Research shows that using adhesives like cyanoacrylate for wound closure in surgeries, including spinal and other types, is generally safe and does not increase the risk of complications compared to traditional methods like sutures and staples. ^{6 7 8 9 10}

Is the closure technique a promising treatment for spinal injury?

Yes, the closure technique is promising for spinal injury. It includes methods like skin adhesives, which are effective and easy to use, and vacuum-assisted closure, which helps heal infections without removing spinal hardware. These techniques offer benefits like quick application, preventing infections, and maintaining spinal stability. ^{1 6 7 11 12}

How does the wound closure treatment for spinal injury differ from other treatments?

This treatment uses cyanoacrylate skin adhesives, which are quick to apply, easy to use, and have a hemostatic (bleeding control) effect, making them different from traditional sutures or staples. They are also bacteriostatic (prevent bacteria growth) and biodegradable, offering advantages in wound healing and reducing complications. ^{1 6 7 11 12}

Research Team

Arjun Sebastian, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 with a primary diagnosis of spinal stenosis who need surgery for either one or two-level posterior spinal decompression or fusion. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

I am recommended to have surgery for 1 or 2 spinal levels.

I am 18 years old or older.

My primary diagnosis is spinal stenosis.

Exclusion Criteria

I have had surgery on my spine before.

I have been diagnosed with peripheral arterial disease.

Iodine Allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo spine surgery with one of three wound closure techniques: Running Subcuticular Suture, Interrupted Vertical Mattress Suture, or Staple Closure Techniques. Perfusion measurements are taken during the procedure.

At time of procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure, focusing on wound healing and perfusion.

4 weeks

Treatment Details

Interventions

• Closure technique

Trial Overview The study is examining the effectiveness of three different wound closure techniques after spine surgery, focusing on how they affect blood flow around the wound site.

Participant Groups

Group I: Running Subcuticular Suture Active Control 1 Intervention

Group II: Interrupted Vertical Mattress Suture Active Control 1 Intervention

Group III: Staple Closure Techniques Active Control 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The modified vacuum-assisted closure (VAC) treatment, combined with a closed suction irrigation system, effectively reduced wound size and promoted healing in 18 patients with postoperative spinal wound infections, with complete healing achieved in an average of 17 days.

This approach was found to be safe and reliable, with no recurrence of infection at the 1-year follow-up, and it significantly shortened the average hospital stay to 33 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure combined with a closed suction irrigation system for treating postoperative wound infections following posterior spinal internal fixation. Chen, K., Lin, JT., Sun, SB., et al.[2020]

In a retrospective review of 12 patients with deep infections after spinal surgery, the use of the vacuum-assisted closure (VAC) system resulted in clean closed wounds without the need for complex surgeries or complete implant removal.

All patients required antibiotic treatment, but none developed new infections post-treatment, highlighting the VAC system's effectiveness in managing post-operative wounds and reducing the risk of further complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-Assisted Closure in Patients with Post-operative Infections after Instrumented Spine Surgery: A Series of 12 Cases. Kale, M., Padalkar, P., Mehta, V.[2022]

In a study of 73 patients with spinal wound infections, the use of vacuum-assisted wound closure (VAC) was effective, with 98% achieving a clean, closed wound after an average of 1.4 procedures and a follow-up of 14 months.

The presence of methicillin-resistant Staphylococcus aureus (MRSA) or multiple bacteria was identified as a key factor influencing the need for additional debridements before final wound closure, highlighting the importance of infection type in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of spinal wound infections using vacuum-assisted wound closure: risk factors leading to resistance to treatment. Ploumis, A., Mehbod, AA., Dressel, TD., et al.[2014]

In a study of 36 patients with wound infections after spinal surgery, 34 patients healed successfully, indicating that with proper treatment, the majority can recover from this serious complication.

The use of an irrigation-suction system was found to be more effective than debridement alone, and in cases with internal fixation, most implants could be retained, suggesting that implant removal is not always necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of wound infection after spinal operation]. Tian, Y., Chen, ZQ., Zhou, F., et al.[2010]

Wound complications are a common issue after pediatric spinal deformity surgery, leading to significant emotional, physical, and financial burdens for patients and families.

Collaborative care involving both spinal and plastic surgeons has been shown to reduce the rates of wound complications in children with nonidiopathic scoliosis, highlighting the importance of interdisciplinary approaches in surgical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilayered and Flap Closure Technique for Pediatric Spinal Deformity Surgery. Garg, S., Khechoyan, D., Kim, EB., et al.[2023]

N-butyl-2-cyanoacrylate glue was effectively used for skin closure in patients after surgery, showing good healing outcomes with no significant cosmetic impairment at the end of the study.

The use of this topical skin adhesive resulted in a simple and efficient wound closure process, demonstrating advantages such as cost-effectiveness and ease of application compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To Evaluate the Efficacy and Effectiveness of N-butyl-2-cyanoacrylate glue (TRU SEAL) in Closure of Oral and Maxillofacial Laceration and Surgical Incisions. Singh, PK., Degala, S., Shetty, S., et al.[2022]

In a study of 382 patients undergoing posterior spinal surgery, using cyanoacrylate skin adhesives (CSA) for incision closure did not increase the risk of wound-related complications such as cerebrospinal fluid leaks, infections, or dehiscence compared to traditional nylon closure techniques.

The findings suggest that CSA is a safe and effective alternative for skin closure in spinal surgeries, including those involving intradural procedures, providing similar complication rates to established methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Octyl-cyanoacrylate skin adhesive is effective for wound closure in posterior spinal surgery without increased risk of wound complications. Howard, BM., Eshraghi, SR., Holland, CM., et al.[2014]

In a study of 160 patients undergoing total hip or knee arthroplasty, the suture technique showed a trend toward shorter closure times compared to newer methods like zipper devices and mesh, although this was not statistically significant.

All wound closure techniques, including sutures, zipper devices, and mesh, demonstrated equivalent rates of complications, suggesting that the choice of method can be based on cost and provider preference rather than safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Center Randomized Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications. Greenbaum, S., Zak, S., Tesoriero, PJ., et al.[2022]

Understanding various suturing techniques and materials is crucial for achieving optimal surgical outcomes and minimizing complications like infections and scarring.

The review aims to equip surgical nurses and first assistants with practical knowledge on effective wound closure methods, specifically tailored for coronary, surgical, and vascular surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The registered nurse first assistant role in surgical wound closure: an integrated review. East, SA.[2019]

The audit demonstrated that using tissue adhesives in an emergency department for specific lacerations resulted in safe and effective wound closure.

Patient and practitioner satisfaction was high, indicating that tissue adhesives can provide acceptable healing outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound healing outcomes after laceration repair with adhesive. Lewis, S., Styles, J., Hamer, J., et al.[2011]

In a study of 14 children and adolescents with deep spinal infections, the wound vacuum-assisted closure (VAC) system was effective in promoting wound healing, with all wounds healing successfully over an average follow-up of 44 months.

The VAC system allowed for the retention of spinal instrumentation without complications such as hardware removal or recurrent infections, making it a valuable tool for spinal surgeons, especially in patients with neuromuscular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure for deep infection after spinal instrumentation for scoliosis. Canavese, F., Gupta, S., Krajbich, JI., et al.[2022]

In a study of 7405 patients undergoing spinal surgery, the use of barbed sutures resulted in significantly shorter operating room time (mean of 239 minutes) and lower operating room costs ($6673) compared to conventional sutures (mean of 263 minutes and $7100, respectively).

There were no significant differences in wound complications or readmissions between the barbed suture group and the conventional suture group, indicating that barbed sutures are a safe and cost-effective alternative for wound closure in spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barbed and conventional sutures in spinal surgery patients: an economic and clinical outcomes comparison. Johnston, SS., Chen, BP., Tommaselli, GA., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure combined with a closed suction irrigation system for treating postoperative wound infections following posterior spinal internal fixation. [2020]

2. India pubmed.ncbi.nlm.nih.gov

Vacuum-Assisted Closure in Patients with Post-operative Infections after Instrumented Spine Surgery: A Series of 12 Cases. [2022]

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

Therapy of spinal wound infections using vacuum-assisted wound closure: risk factors leading to resistance to treatment. [2014]

4. China pubmed.ncbi.nlm.nih.gov

[Management of wound infection after spinal operation]. [2010]

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

Multilayered and Flap Closure Technique for Pediatric Spinal Deformity Surgery. [2023]

6. India pubmed.ncbi.nlm.nih.gov

To Evaluate the Efficacy and Effectiveness of N-butyl-2-cyanoacrylate glue (TRU SEAL) in Closure of Oral and Maxillofacial Laceration and Surgical Incisions. [2022]

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

Octyl-cyanoacrylate skin adhesive is effective for wound closure in posterior spinal surgery without increased risk of wound complications. [2014]

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

A Single-Center Randomized Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications. [2022]

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

The registered nurse first assistant role in surgical wound closure: an integrated review. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Wound healing outcomes after laceration repair with adhesive. [2011]

11. England pubmed.ncbi.nlm.nih.gov

Vacuum-assisted closure for deep infection after spinal instrumentation for scoliosis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Barbed and conventional sutures in spinal surgery patients: an economic and clinical outcomes comparison. [2022]