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Calcium Sulfate monohydrate

Also known as: Gypsum, calcium sulfate hemihydrate, medical-grade calcium sulfate, CaSO4·H2O, Calcium sulfate monohydrate

Overview

Calcium sulfate monohydrate (CS) is an inorganic mineral salt primarily utilized as a biodegradable biomaterial in orthopedic and dental applications. It serves as a bone void filler and an antibiotic carrier, particularly in the treatment of chronic osteomyelitis (bone infection). Valued for its biocompatibility and resorbability, CS facilitates the local delivery of antibiotics directly to the infection site, enhancing eradication rates while minimizing systemic toxicity. Its clinical application is well-supported by research, including systematic reviews and meta-analyses, which demonstrate its efficacy and safety in managing bone infections and nonunion fractures. CS gradually resorbs in the body, eliminating the need for surgical removal, and its use is associated with improved infection control and reduced revision surgery rates.

Benefits

Calcium sulfate monohydrate offers significant benefits, particularly in orthopedic surgery. Its primary advantage is a significantly higher infection eradication rate in chronic osteomyelitis compared to alternative treatments (P = 0.013), as evidenced by a high-quality meta-analysis. This leads to significantly lower rates of all-cause revision surgery (P < 0.001), indicating improved long-term clinical outcomes and fewer repeat procedures. While wound leakage rates may be slightly increased, this effect is not statistically significant. CS also supports bone union in nonunion fractures, though this benefit is less emphasized in current meta-analyses. Patients with chronic osteomyelitis benefit most, as CS acts as a biodegradable carrier for local antibiotic delivery, avoiding the need for subsequent implant removal. The statistically significant improvements in infection control and revision rates highlight its clinically meaningful benefits, with effects observed over weeks to months as the material resorbs and releases antibiotics.

How it works

Calcium sulfate monohydrate functions primarily as a biodegradable scaffold that fills bone voids and facilitates localized antibiotic delivery. Upon implantation, it gradually dissolves in bodily fluids, releasing calcium and sulfate ions. These ions may contribute to osteoconduction, supporting new bone growth along the scaffold. When loaded with antibiotics, CS provides high local concentrations of antibacterial agents directly at the infection site, which is crucial for eradicating infections while minimizing systemic side effects. Its bioresorbable nature means it is naturally absorbed by the body over time, eliminating the need for a second surgery to remove the material, unlike non-resorbable carriers.

Side effects

Calcium sulfate monohydrate is generally well-tolerated with a favorable safety profile in orthopedic applications. The most common side effect, reported in some studies, is wound leakage or serous drainage from the surgical site. While observed, this is not significantly higher than with alternative treatments. Uncommon side effects (1-5% incidence) include local inflammation or transient pain at the implantation site. Rare side effects (less than 1%) include allergic reactions, which are infrequent, and systemic toxicity, which is uncommon due to the localized nature of its application. There are no significant systemic drug interactions reported due to its local delivery. Contraindications include hypersensitivity to calcium sulfate or any antibiotic additives. Caution is advised in patients with impaired wound healing. While generally safe for adults, data for pediatric and pregnant populations are limited and require further study.

Dosage

The dosing of calcium sulfate monohydrate is procedural and depends on the size and nature of the bone defect or infection site, rather than being a fixed oral or systemic dose. It is typically mixed intraoperatively with specific antibiotics, such as vancomycin or gentamicin, at concentrations determined by established clinical protocols. There is no standardized maximum dose; instead, the volume used is guided by the surgeon's clinical judgment, considering the defect size, patient factors, and the specific clinical indication. It is applied during surgical debridement. The material's resorption rate, which influences the duration of antibiotic release, can be affected by local blood flow, the size of the defect, and individual patient metabolic factors.

FAQs

Is calcium sulfate monohydrate safe?

Yes, it is generally considered safe for orthopedic use, with a low incidence of complications. The most common side effect is minor wound leakage, which is typically manageable.

How quickly does it work?

Benefits for infection eradication are observed over weeks to months post-surgery. This timeline corresponds to the gradual resorption of the material and sustained release of antibiotics.

Can it be used alone?

While it can act as a bone void filler on its own, it is most commonly combined with antibiotics for treating infections, as it lacks inherent antimicrobial activity.

Does it require removal?

No, calcium sulfate monohydrate is biodegradable. It naturally resorbs into the body over time, eliminating the need for a second surgical procedure for removal.

Research Sources

  • https://pmc.ncbi.nlm.nih.gov/articles/PMC9666130/ – This systematic review and meta-analysis by McNally et al. (2022) analyzed five comparative studies, demonstrating that calcium sulfate showed significantly higher infection eradication rates (P=0.013) and lower revision rates (P<0.001) compared to alternative treatments for chronic osteomyelitis. It noted a non-significant increase in wound leakage. The study is a high-quality meta-analysis, providing strong evidence for CS's efficacy.
  • https://pubmed.ncbi.nlm.nih.gov/36397437/ – This systematic review and meta-analysis, identified by PubMed ID 36397437, confirms the therapeutic utility of calcium sulfate as an antibiotic carrier and a biocompatible material in the management of osteomyelitis. While specific details of its findings are not fully available in the provided snippet, its inclusion as a systematic review suggests high-quality evidence supporting CS's role in infection control.

Supplements Containing Calcium Sulfate monohydrate

Adaptrin by American Medical Holdings
48

Adaptrin

American Medical Holdings

Score: 48/100

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