Page 202 - Clinical relevance of current materials for cranial implants
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Chapter 10
The primary outcome measure of this future RCT needs to be subsequent implant loss, since this is particularly relevant for the patients involved. Additionally, morbidity, number of reconstructive surgeries or the need for permanent protection are important secondary outcome parameters.
Our systematic review described in chapter 23 showed that the usability of the material as perceived by the surgeons was not taken into account. Details about wound care were also lacking. These two aspects should be included in future research. In this RCT study the surgeon who performs the cranioplasty procedure should assess the usability of the material during surgery, the need for additional intra-operative adjustments and surgery time required to install implant. In general, the time of surgery corresponds with increasing infection rates. Wound care after cranioplasties has never properly been defined or studied in the literature. Variation in the wound care protocol may also affect infection rates. The design of the scalp incision is believed to influence complication rates and should therefore be recorded in the RCT study. The initial incision should be performed over unaffected bone, outside the area of reconstruction, to permit ideal soft tissue coverage and facilitate uneventful wound healing. On the other hand, incision and closure lines over an implant may lead to increased infection rates, especially in case of wound dehiscence.
Whilst patient recruitment in a RCT will take a substantial amount of time, the development of new materials for cranioplasties should not be discontinued in the meantime. Each PMMA subtype has a specific release pattern of residual monomers. To investigate what the effect of residual monomers is on human cells, particularly on cells of the dura and the effect on the surrounding bone, an in vitro study seems indicated. To optimize anti-bacterial properties and reduce infection rates of the cranioplasty, some innovations may be considered:
1) an anti-bacterial substance could be added to the cranioplasty material that elutes from the material cranioplasty;
2) little holes or corridors may be added in the cranioplasty material that are filled with anti-bacterial substance, which is slowly released from the material during the crucial period of healing time;
3) an anti-bacterial foam or spray that could be applied over the cranioplasty or parts of the cranioplasty to prevent the forming of biofilm and bacterial adhesion.



























































































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