Tie-Over Bolster Dressing for Surgical Scars

Recruiting at 1 trial location

Overseen By Keemberly Kim, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Pregnant, Under 18, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-surgery

50 Participants Needed

Trial Summary

What is the purpose of this trial?

When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. One idea is to reduce the tension around the cut. One way to reduce tension is to stitch a small piece of a special gauze over the top of the regular stitches. This procedure is called a "tie-over bolster dressing." As the name implies, this extra dressing "bolsters" the wound closure so that the skin on each side of the cut stays in place. The bolster dressing procedure has been used in the past in special cases, such as when skin grafts are necessary. The bolster dressing helps the skin graft heal by making sure the graft stays exactly in place. Keeping the wound stable with a bolster dressing also reduces bleeding under the wound. For non-grafted wounds, the bolster dressing procedure has not normally been used, and has not been well-studied. In this study the whole wound will be stitched normally and then the bolster dressing will be applied over half of the wound. This will allow us to see if the side with the bolster dressing heals with less scarring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Tie-Over Bolster Dressing for Surgical Scars?

The tie-over bolster dressing is a traditional method used to secure skin grafts, but it may not always provide satisfactory results in difficult body areas. However, a study found that a novel, low-cost method of repeated tie-over dressing resulted in complete skin graft take without complications, suggesting its potential effectiveness in maintaining proper graft position. ^{1 2 3 4 5}

Is the tie-over bolster dressing safe for use in humans?

The tie-over bolster dressing is generally safe for use in humans, but it may cause issues like hematoma (a collection of blood outside of blood vessels) and seroma (a pocket of clear fluid) due to uneven pressure. Studies show no significant differences in safety outcomes like infection rates when compared to other dressing methods. ^{1 2 5 6 7}

How does the tie-over bolster dressing treatment for surgical scars differ from other treatments?

The tie-over bolster dressing is unique because it applies consistent pressure to secure skin grafts, which is crucial for healing. Unlike other methods, it can be easily adjusted or replaced, allowing for quick inspection and reapplication if needed, making it particularly useful in areas where grafts are prone to movement or complications. ^{1 2 5 6 8}

Research Team

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Eligibility Criteria

This trial is for adults over 18 who are having surgery on their head or neck and can close the wound right away. They must be able to consent and come back for a check-up. It's not for those with small wounds, under 18s, prisoners, pregnant women, or those who don't understand English.

Inclusion Criteria

Able to give informed consent themselves

I am scheduled for skin surgery on my head or neck that will be closed up right away.

Willing to return for follow-up visit

Exclusion Criteria

Incarceration

Pregnant women

My wound is expected to close and is less than 3cm long.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical procedures with either standard layered closure or layered closure with tie-over bolster dressing

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for scar assessment and complications using POSAS and trace-to-tape methods

3 months

Multiple visits (in-person)

Treatment Details

Interventions

• Addition of Tie-Over Bolster Dressing

Trial Overview The study tests if adding a 'tie-over bolster dressing'—a special gauze stitched over regular stitches—on half of the surgical wound reduces scarring compared to just stitches alone.

Participant Groups

Group I: Layered Closure with Tie-Over Bolster Dressing Experimental Treatment 1 Intervention

The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.

Group II: Layered Closure Active Control 1 Intervention

A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

In a study of 86 patients, negative-pressure wound therapy significantly improved skin graft take rates compared to tie-over bolster dressing, achieving a 97.2% success rate versus 90.2%.

Negative-pressure wound therapy also reduced the risk of graft displacement and shortened dressing time, making it a more effective and efficient option for securing skin grafts in irregular, high-mobility areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative-Pressure Wound Therapy Improves Take Rate of Skin Graft in Irregular, High-Mobility Areas: A Randomized Controlled Trial. Cao, X., Hu, Z., Zhang, Y., et al.[2022]

The review compares the effectiveness of tie-over bolster dressings and basting sutures in securing full-thickness skin grafts, highlighting their roles in promoting graft adherence and healing.

Evidence suggests that tie-over bolster dressings may provide better outcomes in terms of graft survival and patient comfort compared to basting sutures, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corrigendum. [2019]

In a study involving 212 patients, the use of a polyurethane sponge dressing resulted in a higher success rate of 97.1% for skin grafts, compared to 89.6% with the traditional tie-over bolster dressing.

The polyurethane sponge dressing significantly reduced complications, with only 3 out of 106 patients experiencing issues, highlighting its efficacy as a superior alternative for graft fixation in challenging body areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin grafting: comparative evaluation of two dressing techniques in selected body areas. De Gado, F., Chiummariello, S., Monarca, C., et al.[2008]

A novel low-cost tie-over dressing method using sterile sample collection containers was successfully tested in eight patients, allowing for easy inspection and reapplication without disrupting the graft.

All patients experienced complete graft take without complications such as seroma or hematoma, demonstrating the efficacy and safety of this new dressing technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple and rapid method of repeated tie over dressing. Singh, H., Aggarwal, A., Khazanchi, RK., et al.[2020]

In a study of 128 patients with skin defects, the double tie-over dressing significantly reduced healing time in the head and neck region, averaging 9.19 days compared to 11.05 days for the simple bolster dressing.

The results indicate that the double tie-over dressing is more effective for securing skin grafts and promoting faster healing, with a statistically significant difference (P-value of 0.003) between the two dressing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of double tie-over dressing compared with bolster dressing. Lee, SH., Kim, YJ.[2020]

The new tie-over dressing method using bra hooks and packing rubber bands effectively secures skin grafts to prevent complications like fluid accumulation and graft movement, which are critical for successful healing.

This innovative dressing allows for easy and quick renewal while maintaining adequate pressure and immobilization, addressing common challenges faced with traditional tie-over dressings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new useful and renewable tie-over dressing method using package bands and bra hooks. Doğan, F., Ozyazgan, I., Eskitaşçoğlu, T.[2006]

In a study of 266 patients who underwent skin grafting, there were no significant differences in graft take rates, healing periods, wound infection rates, or hematoma formation between those using tie-over dressings and those using alternative dressings.

The findings suggest that while tie-over dressings may still be necessary for certain areas like eyelids and lips, polyurethane foam dressings can be effective alternatives for most skin grafting cases, potentially reducing complications and operative time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the use of tie-over dressing after skin grafting. Yuki, A., Takenouchi, T., Takatsuka, S., et al.[2018]

The new tie-over dressing design, featuring a flanged disc and neoprene sealing ring, enhances the traditional method used in plastic surgery by making it easier and faster to apply.

This innovative dressing allows for adjustments to the sutures after application and enables early inspection of grafts by allowing for easy removal and replacement, improving overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pressure button: a refinement of the traditional "tie-over" dressing. Burd, DA.[2019]

References

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

Negative-Pressure Wound Therapy Improves Take Rate of Skin Graft in Irregular, High-Mobility Areas: A Randomized Controlled Trial. [2022]

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

Corrigendum. [2019]

3. Greece pubmed.ncbi.nlm.nih.gov

Skin grafting: comparative evaluation of two dressing techniques in selected body areas. [2008]

4. Germany pubmed.ncbi.nlm.nih.gov

A simple and rapid method of repeated tie over dressing. [2020]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of double tie-over dressing compared with bolster dressing. [2020]

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

A new useful and renewable tie-over dressing method using package bands and bra hooks. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Investigating the use of tie-over dressing after skin grafting. [2018]

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

The pressure button: a refinement of the traditional "tie-over" dressing. [2019]