Tie-Over Bolster Dressing for Surgical Scars

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Daniel Eisen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Davis

Disqualifiers: Incarceration, Pregnant, Under 18, others

No Placebo Group

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.

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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.

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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.

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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.

Trial 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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, Davis - Dermatology Department Sacramento, CA

UC Davis Dermatology Sacramento, CA

Who Is Running the Clinical Trial?

University of California, Davis Lead Sponsor

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] Tie-over bolster dressing to secure a skin graft is associated with low graft take rates in irregular, high-mobility areas and suboptimal recipient wound beds. Negative-pressure wound therapy has become a well-established method to secure the graft, with a graft take rate of this method reported to be 96.7 percent. However, comparative efficacies between the two methods on irregular, high-mobility areas are yet to be determined.

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

Corrigendum. [2019] Kromka W, Cameron M, Fathi R. Tie-over bolster dressings vs basting sutures for the closure of full-thickness skin grafts: a review of the literature. J Cutan Med Surg. 2018. Original DOI: 10.1177/1203475418782152.

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

Skin grafting: comparative evaluation of two dressing techniques in selected body areas. [2008] Skin grafting is a frequent surgical procedure used to reconstruct a soft-tissue deficit. Tie-over bolster dressing is the traditional technique made to fix the graft to the recipient area. This dressing does not always provide satisfactory results in some difficult body areas, with poor skin graft taking as an outcome. Here, we used a soft "polyurethane sponge" as a compressive tool.

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

A simple and rapid method of repeated tie over dressing. [2020] Tie overdressing is commonly used to secure the graft against the raw surface and prevent loss due to of hematoma or seroma. A conventional tie over dressing with silk sutures, is a useful method of securing the graft to raw area. Refixation is difficult when repeated tie over dressings are needed. We assessed a low cost repeated tie over dressing method using sterile sample collection containers and silk suture threads in eight patients. After the graft is applied on the bed, tie-over stitches are taken, and paraffin gauze is applied over with adequate padding; the tie over sutures are passed through the container and the lid is tightened over it to complete the dressing. The lid can be unscrewed easily at any time to inspect the graft and can be easily reapplied in the outpatient department. The skin graft take in all the patients was complete without any seroma or hematoma. A novel and low-cost tie over dressing that enables simple fixation of the dressing, to maintain proper position of grafts that require repeated fixation is reported here.

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

Effectiveness of double tie-over dressing compared with bolster dressing. [2020] Skin grafting is a commonly performed operation in plastic and reconstructive surgery. The tie-over dressing is an effective technique to secure the grafted skin by delivering persistent downward pressure. However, if an additional dressing is required due to incomplete graft healing, the process of re-implementing the tie-over dressing may be frustrating for both patients and surgeons. Therefore, we introduce the double tie-over dressing, which readily allows for an additional tie-over dressing after the first dressing, and we present a comparison of its effectiveness with that of the simpler bolster dressing.

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

A new useful and renewable tie-over dressing method using package bands and bra hooks. [2006] The purposes of the tie-over dressing are to secure a skin graft toward the wound bed to avoid complications such as fluid or blood accumulation and to prevent graft movements over the wound bed. When there is a concern of uneventful graft take because of infection or blood accumulation underneath the graft, it is necessary to check the status of the graft at the postoperative first and subsequent days. Therefore, an ideal tie-over dressing method should not only ensure adequate immobilization and pressure but also be able to be renewed simply and quickly. We developed a new tie-over dressing method by using bra hooks and packing rubber bands to solve these problematic issues.

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

Investigating the use of tie-over dressing after skin grafting. [2018] Tie-over bolster dressing after skin grafting can prolong operative time, and cause hematoma and seroma formation because of uneven pressure application. To describe the possibility of discontinuing the use of tie-over dressing, we carried out a retrospective comparative study of patients who underwent skin grafting at an institution between January 2009 and December 2014. We investigated and compared the take rate, healing period, wound infection rate and hematoma formation rate for the tie-over dressing group and the non-tie-over dressing group. Among 266 patients, 148 and 118 patients were included in the tie-over dressing group and non-tie-over dressing group, respectively. There were no significant differences between the take rate, healing period, wound infection rate and hematoma formation rate for the two groups. Multivariate analysis showed that the complete graft take rate was not significantly influenced by tie-over dressing, age, sex, graft site, graft procedure and skin graft diameter. Although the use of tie-over dressing might remain necessary on sites with a free margin, including the eyelids, lips or nostrils, because of the difficulty in using tape fixation, the present study showed that alternative dressing with polyurethane foam is also useful in most cases of skin grafting.

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

The pressure button: a refinement of the traditional "tie-over" dressing. [2019] The "tie-over" dressing is commonly used in plastic surgical practice. A simple, cheap and effective refinement of this established technique is described. This consists of a flanged disc over which can be slipped a "neoprene" sealing ring. The advantages of the device include the ease and speed of application: the facility to tighten and adjust the tie-over sutures once they are in place and the possibility of removing and replacing the device if early inspection of the graft is desired.