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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to reduce scarring from head and neck surgeries. Typically, doctors close these wounds with stitches, but this trial adds a special gauze, called a "tie-over bolster dressing," over part of the wound. The goal is to determine if this extra layer helps the scar heal better by reducing tension on the skin. Suitable participants are those scheduled for head or neck surgery with a wound expected to be at least 3 cm long and who are willing to attend follow-up visits. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve surgical outcomes 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.

What prior data suggests that the tie-over bolster dressing is safe for reducing scarring?

Research has shown that the tie-over bolster dressing has been successfully used in surgeries like skin grafts. One study with 212 patients reported a 97.1% success rate for a similar dressing in skin grafts, indicating its effectiveness and tolerance in stabilizing wounds.

The bolster dressing reduces tension on the skin, which aids healing. It stabilizes the wound and can also help reduce bleeding. Although not widely studied for wounds without grafts, its success with skin grafts suggests general safety. No major reports of negative effects have emerged from its use.

The bolster dressing appears to be a promising method for improving wound healing with fewer complications. Available evidence suggests it is a safe option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tie-Over Bolster Dressing for surgical scars because it offers a novel way to potentially enhance healing and reduce scarring. Unlike the standard layered closure technique, which only uses sutures, this method adds a bolster dressing to apply gentle pressure to the wound. This pressure can help stabilize the wound edges and promote more even healing, which might lead to smoother, less noticeable scars. This innovative approach could mean better cosmetic outcomes and greater patient satisfaction compared to traditional methods.

What evidence suggests that the tie-over bolster dressing is effective for reducing surgical scars?

Research has shown that tie-over bolster dressings can improve wound healing by reducing pressure around the cut. This method often secures skin grafts and minimizes bleeding. In a study with 212 patients, this dressing type achieved a higher success rate for skin grafts. Some patients also experienced faster healing with this approach. In this trial, one group will receive a layered closure with a tie-over bolster dressing, while another group will receive a standard layered closure. These findings suggest that tie-over bolster dressings might enhance healing and reduce scarring for surgical wounds. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Eisen, MD

Principal Investigator

University of California, Davis - Dermatology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9141235/

Tie-Over Bolster Pressure Dressing Improves Outcomes of ... Moreover, the tie-over bolster dressing technique not only stabilizes the graft but also absorbs exudate from the wound. In some situations, ...

2. journals.lww.com journals.lww.com/dermatologicsurgery/fulltext/2013/10000/tie_over_bolster_for_second_intention_wound.22.aspx

Tie-Over Bolster for Second-Intention Wound Healing In one case series of defects allowed to heal by second intention, 83% of patients and 70% of physicians rated both functional and cosmetic outcomes at 12 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0266435622000766

Are tie-over bolster dressings necessary for healing or ... This retrospective study has shown FTSG success in cutaneous defects of the head and neck to be excellent without the use of tie-over bolsters.

4. withpower.com withpower.com/trial/phase-surgical-wound-4-2023-f889c

Tie-Over Bolster Dressing for Surgical Scars 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5968322/

Effectiveness of double tie-over dressing compared with ... The mean healing time for the head and neck region in the double tie-over dressing group was 9.19±1.78 days, while it was 11.05±3.85 days in the ...

6. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT05758168

Aesthetic Outcome of Tie-over Bolster Application in Surgical ... This study seeks to determine the effectiveness of a tie-over bolster dressing in reducing tension to improve scar cosmesis.

7. mdpi.com mdpi.com/1648-9144/55/12/781

Retrospective Study on the Clinical Superiority of ... In the present study, the silicon-based dressing with VAC produced significantly less tearing pain during dressing removal compared with the conventional tie- ...

8. researchgate.net researchgate.net/publication/360616774_Tie-Over_Bolster_Pressure_Dressing_Improves_Outcomes_of_Skin_Substitutes_Xenografts_on_Athymic_Mice

(PDF) Tie-Over Bolster Pressure Dressing Improves ... The new grafting method reduced medium and large displacement events by 1.26-fold and medium and large contraction events by 1.8-fold, leading ...