Vokurka, S., Skardova, J., Hruskova, R., Kabatova-Maxova, K., Svoboda, T., Bystricka, E., et al. (2011). The effect of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) on oral microbial colonization and pain control compared with other rinsing solutions in patients with oral mucositis after allogeneic stem cells transplantation. Medical Science Monitor : International Medical Journal of Experimental and Clinical Research, 17(10), CR572-6.

Study Purpose

To assess the efficacy, tolerance, and impact on oral cavity microbial colonization in patients with OM post-allogeneic hematopoietic stem cell transplantation.  

Intervention Characteristics/Basic Study Process

Oral cavity nursing care with benzydamine, chlorhexadine, or saliva solutions was started on the first day of conditioning chemotherapy administration and covered the entire inpatient stay. Gelclair was begun for 22 consecutive patients on the day of the development of OM and continued until the OM resolved when oral cavity nursing care was resumed until the patient was discharged.

Sample Characteristics

The study was comprised of 37 patients, age 19-68 years.

There were 51 males and 49 females.

KEY DISEASE CHARACTERISTICS: AML, ALL, CLL, CML, HL, NHL, MDS, MM

 

Setting

SITE: Single site

LOCATION: Stem Cell Transplant Center of Hokkaido University Hospital

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

Prospective observational study in adults with oral mucositis post-allogeneic stem cell transplant in 2008-2009.

Measurement Instruments/Methods

  • WHO Grading 0-4 daily    
  • VAS for tolerance of oral rinses daily 1-5 scale (1 = tolerable without any problems and 5 = intolerable)  
  • Pain reduction and food intake improved daily, VAS score 1-5 (1 = excellent and 5 = no effect at all).
  • Oral cavity swabs weekly in the AM beginning on admission to the transplant unit and continuing through the post OM phase
     

Results

There was no difference in the median value of tolerability of the rinses. There was also no difference in the improvement of oral intake. The duration of pain relief was significantly longer in the Gelclair group, and significantly fewer pathogens were found in the Gelclair group compared to the control group. There was significant increase in pathogen colonization after discontinuation of the Gelclair in the post OM phase.

Conclusions

Gelclair may be helpful in the management of OM and pain in some patients after allogeneic stem cell transplant. Use of Gelclair seemed to have helped protect the mucosa from enterococcus and candida colonization.

Limitations

Small sample <30

No cost comparison performed.

Nursing Implications

Further randomized controlled studies are needed to assess the efficacy of Gelclair in the transplant population. There is also further study needed regarding the reduction in incidence of pathogen colonization with the use of Gelclair and to clarify the cost effectiveness of this treatment regimen.