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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different wound closure techniques affect blood flow around the wound site after spinal surgery. Researchers are comparing stitches that run under the skin, stitches that loop across the wound, and metal staples. Individuals diagnosed with spinal stenosis and scheduled for specific types of spinal surgeries might be suitable candidates for this study. Participants should not have had previous spinal surgeries or be on long-term medications such as steroids or blood thinners. As an unphased trial, this study provides a unique opportunity to contribute to medical knowledge and potentially improve surgical outcomes for future patients.

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 prior data suggests that these wound closure techniques are safe for spinal injury?

Studies have shown that the running subcuticular suture is often used in spine surgery for its cosmetic appeal and because it does not require later removal. Research suggests this method might carry a lower risk of deep surgical site infections compared to staples.

For the interrupted vertical mattress suture, research indicates it is generally effective and safe. However, some studies found it can cause more pain than simpler sutures, and there is a risk of tissue tearing if placed too close to the wound edge.

Regarding staple closure techniques, studies suggest these might have a higher risk of deep surgical site infections compared to running subcuticular sutures. Despite this, staples remain popular due to their speed and ease of use.

In summary, the three closure techniques each have their own benefits and risks. Running subcuticular sutures might lower infection risks, interrupted vertical mattress sutures might cause more pain and tissue tearing, and staples are fast to use but might lead to more infections. Each method has been generally effective and safe in various surgical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative wound closure techniques following spinal injury. Unlike traditional methods, such as simple sutures or staples, this trial compares running subcuticular sutures, interrupted vertical mattress sutures, and staple closure techniques. Each method aims to improve healing time, reduce infection rates, and enhance cosmetic outcomes. By evaluating these techniques, researchers hope to identify the most effective approach for optimizing recovery and minimizing complications in spinal surgery.

What evidence suggests that these wound closure techniques are effective for spinal injury?

This trial will compare different wound closure techniques for spinal surgery. Research has shown that each technique offers distinct benefits. Participants may receive running subcuticular sutures, which are stitches placed under the skin. Studies have found that this method often results in better-looking scars and fewer infections than staples, with one study reporting no infections with sutures compared to an 8% infection rate with staples.

Another group will receive interrupted vertical mattress sutures. Some studies found no major infections or healing problems with these, although they might cause more pain than simpler stitches.

A third group will receive staple closure techniques. Staples can be useful, especially for reducing infections in certain groups, like people who are obese. However, using staples might require a longer hospital stay. Each method has its advantages, and the best choice depends on individual needs and conditions. ^{4 5 6 7 8}

Who Is on the Research Team?

Arjun Sebastian, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9797933/

Comparing running vs interrupted sutures for skin closure The overall infection rate was 4.4% (3.6% in the continuous suture group and 5.2% in the interrupted suture group). We did not find a ...

2. researchgate.net researchgate.net/publication/394946580_Simple_Suture_vs_Vertical_Mattress_Choosing_the_Best_Suture_for_Palmar_Incision_Based_on_a_Randomized_Clinical_Trial

Choosing the Best Suture for Palmar Incision Based on a ... Results: The mean pain was higher in the vertical mattress sutures group compared with simple sutures, though the pain difference was statistically significant ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/073567579390090X

The shorthand vertical mattress stitch: Evaluation of a new ... No infectious complications, delayed wound healing, or cosmetic problems were observed with the shorthand technique. The shorthand vertical mattress stitch ...

4. 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.

5. withpower.com withpower.com/trial/phase-spinal-injuries-3-2019-f53b1

Wound Closure Techniques for Spinal Injury The safety data for wound closure techniques, including sutures, staples, and adhesives, indicates that these methods are generally effective and safe.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106352/

Progress in tension-relieving suturing surgery This review comprehensively examines the evolution, design principles, and clinical applications—with evidence-based outcomes—of tension-relieving suture ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/clr.14273

The distance of insertion points from wound margins in ... With interrupted sutures, tissue tearing occurred in 22.5% of cases when the insertion points were either at the margin or 1 mm from it, while ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10936887/

Comparative Study of Use of Reusable Skin Staples and ... The aim of this study was to compare the use of skin staples and vertical mattress sutures in the closure of midline abdominal wounds. Materials and Methods:.